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FOREWORD
Ayurveda and Siddha have been in vogue in this country from the earliest times, serving
the medical needs of most of our people. These systems were developed by ancient scholars on
the basis of their own philosophy, oriental methodologies and practices prevalent in that era and
have popularized and almost completed it in all aspects as a system of medicine. The advent of
foreign invasion and cross interaction had definite impact on these systems.
The worldwide interest in the use of natural products and plant-based remedies had led to
different situations developing in different countries. In countries with a strong foundation of
traditional medicine such as India and China, nationally recognized parallel traditional systems have
run for long periods, along with Western medicine with varying degrees of acceptance, integration
and assimilation.
During the last decade, use of traditional medicine has expanded globally and has gained
popularity. It has not only continued to be used for primary health care of the poor in developing
countries, but has also been used in countries where conventional medicine is predominant in the
national health care systems. With the tremendous expansions in the use of Ayurveda and Siddha
world wide, the safety and efficacy as well as quality control of herbal medicines and traditional
procedure-based therapies have become important concerns for both health authorities and the
public. Various practices of traditional medicine have been developed in different cultures in
different regions without a parallel development of international standards and appropriate methods
for evaluating Ayurveda and Siddha systems of Medicine. Like other systems of ancient India
learning Ayurveda was discovered through most suitable sources (Pramanas) viz. (1) Pratyaksha
(direct perception), (2) Anumana (logical inference), (3) Aptopadesa (verbal and authentic
documentary testimony) and (4) Yukti (experimental evidence) etc.
In modern medicine, a clinical trial is almost always undertaken to test the efficacy of
pharmaceutical products (drugs, devices etc.) and some times to study the efficacy of ‘non-
therapeutic interventions’. The global acceptance of modern system of medicine as a whole is
because it has been reviewed systematically by modern scientific parameters. Similar scientific
evidences through clinical trials are the need of time, to make the traditional medical systems
scientifically acceptable by all.
III
scientists to devise parameters and design suitable models for clinical studies/trials. The pursuit of
a better understanding of the facts and phenomena in Ayurveda and Siddha, through scientific
research will be able to fill this gap.
Only using the modern scientific tools without considering the holistic concepts of traditional
medical system, may sometimes lead to inappropriate conclusions. This is high time to create the
scientific evidences on Ayurvedic principles and practices taking into the consideration of basic
principles and philosophies embodies in the literature and correlating them with the modern
scientific concepts, which will rightly convey and translate the merits of Ayurveda and other
traditional systems of medicine.
The Central Council for Research in Ayurveda and Siddha has been engaged in scientific
research in Ayurveda and Siddha since more than past three decades and executing research
adopting the integrative protocols. I appreciate the involvement of scholars from various reputed
organizations like Indian Council of Medical Research, All India Institute of Medical Sciences, Lady
Harding Medical College, NIMHANS, Bangalore and other institutes while drafting and finalizing
the protocols.
The views and endorsement of experts from both Ayurveda and Allopathic systems
enriched the protocols providing a good scope of integrative research for creating scientific
evidence.
As research methodology is a continuously evolving subject, one should always consult the
current updates and modify the protocols and formats as per the needs from time to time. This
document would greatly serve as basic reference material for scientists and scholars who are
involved in clinical research in Ayurveda, Siddha and other traditional systems of medicine.
I appreciate the efforts of CCRAS in bringing out this document and would certainly
receive a warm welcome from scientists and scholars engaged in traditional medicine research.
IV
PREFACE
Research is essential for development of any science. This is even more necessary in
respect of ancient sciences like Ayurveda and Siddha. The various schemes and initiatives of
Government of India led to establishment of a National body “Central Council for Research in
Indian Medicine and Homeopathy (CCRIMH) in 1969. The Central Council for Research in
Ayurveda & Siddha was started in 1978 as a successor to CCRIMH, for research in Ayurveda
and Siddha.
The Central Council for Research in Ayurveda & Siddha, Department of AYUSH, Ministry
of Health & Family Welfare, Government of India is an apex Nodal Body in India for the
formulation of Research in Ayurveda and Siddha on scientific lines. The research activities of
CCRAS include Literary Research, Drug Research, Clinical Research including Nutraceuticals
Research, Cosmeceutical Research and Bio-medical instrumentation and Reproductive and Child
Health Care Research. The Council has been carrying out its research activities through the
network of the peripheral institutes across the country and also in collaboration with various
National and International academics and Research Organizations.
The Council is executing research studies on scientific lines as per the prevalent guidelines
with Ayurveda and Siddha related part so as to make it integrative in nature. The Council has
currently undertaken execution of clinical trials on more than 30 priority areas on phased manner
adopting the current norms of drug development process viz. pre-clinical standardization/toxicity
studies and phased clinical trials.
The integrative research protocols and Case Report Forms (CRFs) incorporating basic
principles of Ayurveda and current requirement and methodology of research etc. have been
developed from time to time through extensive consultative process involving high profile experts
in the field of Ayurveda and Allopathic system of medicine from reputed institutes viz. AIIMS,
ICMR, CSIR, NIMHANS and so on.
Dissemination of these methodologies by publishing the formats of selected diseases along
with protocols, Case Report Forms (CRFs) would help the scientists, academicians, PG and
V
Ph.D. scholars etc. who wish to conduct research on different diseases/conditions in developing
protocols and serving as a basic reference material. However, the specific protocol could be
developed by individuals suitable to their needs based on the specific objectives.
There has been a great need for a comprehensive compendium of Protocol formats and
Case Report Forms (CRFs) for ready reference of research scholars, scientists etc. Keeping this
in view the Council is publishing the present compendium and I am convinced that this will be of
immense help not only for researchers more so ever to the Post Graduate and Doctorial
Scholars.
I am highly thankful to Dr. C. D. Tripathi, Professor & Head, Deptt. of Pharmacology,
Vardhman Mahavir Medical College & Safdarjung Hospital, New Delhi for sparing his valuable
time by offering suitable suggestions that has made this document more authentic and scientific.
I greatly appreciate the scientists of CCRAS, expert members of task force whose efforts
made this work possible. I also appreciate Dr. M.M. Sharma, Dr. B.S. Sharma, Mr. Upendra
Singh & Mr. Narender Singh from publication section for their tireless efforts in bringing out this
publication, Mr. Gaurav Kumar and Mr. Prasanto Choudhary, Data Entry Operators for secretarial
assistance.
VI
CHIEF EDITOR
EXPERT REVIEWER
EDITOR
PROGRAMME COORDINATOR
Dr. N. SRIKANTH
Assistant Director (Ay.)
Central Council for Research in Ayurveda and Siddha, New Delhi
VII
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VIII
CORE SCIENTIFIC GROUP
IX
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X
TASK FORCE OF EXPERTS FROM REPUTED
INSTITUTES
XI
Dr. Arvind Pandey Dr. Abha Rani Aggarwal
National Institute of Medical Statistics Scientist E
ICMR Head Quarters Campus, Ansari Nagar National Institute of Medical Statistics
New Delhi – 110029 ICMR Head Quarters Campus
Ansari Nagar
New Delhi – 110029
Vallabh Bhai Patel Chest Institute, Sir Ganga Ram Hospital, Delhi
University of Delhi, Delhi
XII
Dr. S.M. Sathe Dr. G. Veluchamy
Plot No. 9 Ex. Director CCRAS,
Gananjay Society Unit – 1 New Delhi
Azad Nagar, Kothrud
Pune – 411038
TECHNICAL SUPPORT
XIII
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XIV
INDEX
XV
6. Section – VI Metabolic Disorders 437
1. 6.1 Obesity (Medoroga) 441
2. 6.2 Diabetes Mellitus (Madhumeha) 459
7. Section – VII Eye Disorders 479
1. 7.1 Cataract (Linganasha) 483
2. 7.2 Dry Eye Syndrome (Shushkakshipaka / Parishuskha 501
Netra)
3. 7.3 Allergic Conjunctivitis (Kaphaja abhishyanda) 519
8. Section – VIII Connective Tissue Disorders 535
1. 8.1 Deep Vein Thrombosis 539
9. Section – IX Geriatric Disorders 557
1. 9.1 Rejuvenation (Rasayana) in healthy elderly persons 561
2. 9.2 Rejuvenation (Kaya kalpa) in healthy elderly persons 593
10. Section – X Reproductive System 615
1. 10.1 Menopausal Syndrome 619
2. 10.2 Dysfunctional Uterine Bleeding 643
3. 10.3 Dysmenorrhoea (Kashtartava) 661
11. Section – XI Cardio Vascular System 701
1. 11.1 Essential Hypertension (Uchcharaktachapa) 705
2. 11.2 Chronic Stable Angina (Hridroga) 727
12. Section – XII Urinary System 745
1. 12.1 Urolithiasis (Mutrashmari) 749
13. Section – XIII Vector Borne Diseases 769
1. 13.1 Kala-Azar 773
2. 13.2 Filariasis (Shleepada) 801
14. Section – XIV Haematological Disorders 827
1. 14.1 Iron Deficiency Anaemia (Pandu) 831
2. 14.2 Sickle Cell Anemia 865
XVI
15. Section – XV Immune System 883
1. 15.1 HIV Infected Persons 887
16. Section – XVI Disorders of Skin 911
1. 16.1 Psoriasis (Kitibha) 915
17. Section – XVII Reproductive and Child Health Care 941
1. 17.1 AYUSH AG TAB during Pregnancy 943
2. 17.2 AYUSH PG TAB in edema during pregnancy 958
3. 17.3 AYUSH B.R. Leham for immunity in infants 973
4. 17.4 AYUSH PK-Avaleha in preventing postpartum 985
complications and puerperial care.
5. 17.5 AYUSH SS-Granules to ensure quality & quantity of 996
breast milk
18. Section – XVIII Clinical Safety of some 1007
Ayurveda and Siddha Drugs
1. 18.1 Clinical safety of herbo-mineral and metallic preparation 1011
(Rasamanikya Rasa)
2. 18.2 Clinical safety of herbo-mineral and metallic preparation 1049
(Vasantakusumakara Rasa).
19. Section – XIX Annexure 1085
1. 19.1 Case Report Form for determination of 1087
Prakriti/Udaliyal/Mizaj
XVII
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XVIII
RESPIRATORY SYSTEM
SECTION - I
1
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2
MULTICENTRIC CLINICAL TRIAL OF AYURVEDIC
FORMULATION IN THE TREATMENT OF KASA
(BRONCHITIS)
3
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4
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC CLINICAL TRIAL OF AYURVEDIC FORMULATION IN THE
TREATMENT OF KASA (BRONCHITIS)
I. BACKGROUND
Kasa (Bronchitis)1is prevalent all over the world and certainly most common acute disease
of lungs. It is characterized by inflammation of brochial tubes and is much more common in
childhood and after middle age. Attacks are much more likely to occur in the winter and spring
seasons. The disease commonly commences with symptoms of an acute respiratory infection and
a slight sore throat. In the course of a day or so it affects the trachea and larger bronchi with
feeling of soreness behind the sternum, tightness in the chest, frequent and mainly dry cough and
a rise in temperature. The voice becomes husky. The sputum is initially thick and scanty but later
on becomes more copious, mucopurulent and more easily to cough ups. In the cases of great
severity, there is a severe bronchitis affecting the larger and smaller tubes, a high rising temperature
(104o – 105o F), severe dyspnoea, cyanosis, and prostration. The sputum may be streaked with
blood. Especially at extremes of life death may occur, or recovery will be taking 4-8 weeks.
According to modern medicine, bronchitis may follow exposure to cold. In majority of cases there
is an infection of upper respiratory tract. A number of drugs including antibiotics are available for
the successful treatment of the disease but recurrence of the condition, development of bacterial
resistance against drug is now a days common. Besides of these number of side effects, adverse
effects of antibiotic therapies have been reported time to time. So it is better to seek for a safe
and effective alternative treatment for the cure.
The disease is very well described in Ayurveda and a number of drugs have been
mentioned. Vyaghriharitaki is one of the classical compound drugs which has been in practice since
ancient times for its successful treatment. A protocol is designed here with special reterence
Vyaghriharitaki which may be principally utilized for management with suitable ammendments.
References
1. Charaka Samhita; Chaukhamba Publication, Varanasi; 2nd Edition; Sutra Sthana, Chapter 25, Verses 40
2. Savill’s System of Clinical Medicine- revised and edited by E.C.Warner, 14th edition, page No. 183- 186
3. Davidson’s Principle and Practice of Medicine 18th Edition pages 339
4. Charaka Samhita; Chaukhamba Publication, Varanasi; 2nd Edition; Chikista Sthana, Chapter 18, Verses 10
&133
5. www.emedicinehealth.com
5
II. OBJECTIVES
1. To evaluate the clinical efficacy of Vyaghriharitaki in the cases of Kasa (bronchitis)
2. To validate the clinical efficacy of Ayurvedic drug Vyaghriharitaki on the scientific
parameters in the patients of Kasa (bronchitis)
3. To evaluate the safety of Vyaghriharitaki in the patients of Kasa (bronchitis).
III. CENTRES
CCRAS centers in collaboration with other centers
IV. SAMPLE SIZE & METHODS
Sample size — 120 (60 patients in each group)
Design of the study — Open clinical study.
Drug/Dosage/Duration
Group – A — Vyaghriharitaki without restriction of pathyapathya
(Restrictions related to diets and life style).
Group – B — Vyaghriharitaki with restrictions of pathyapathya
Dose & Duration — 2.5 gm B.D. for 1 (one) month
Total period — 1 year and 6 months to complete the study
V. CRITERIA FOR INCLUSION
1. Patients of either sex with Age between 15 years to 60 years
2. Cases with confirmed diagnosis by signs/symptoms/lab findings of bronchitis.
3. Duration of illness not more than 6 months.
4. Repeated attacks of bronchitis
5. Smokers.
VI. CRITERIA FOR EXCLUSION
1. Age below 15 years and more than 60 years
2. Cough associated with other respiratory disorders like Bronchial carcinoma, Bronchial
Asthma, Bronchiectasis, cases of tuberculosis, interstitial lung disease/occupational Lung
disease, tropical pulmonary eosinophilia, Loffler`s disease, Allergic Bronchopulmonary
Aspergillosis etc.
3. Diabetes Mellitus, Hypertension and other serious cardiovascular disorders.
6
4. Severe renal/Hepatic disease
5. HIV positive cases
6. Pregnant/lactating mother
7. Any other serious systemic disease.
VII. CRITERIA FOR WITHDRAWAL
During the course of the trial treatment, if any serious condition or any serious adverse
effect / event which requires urgent treatment or if patient by own wants to withdraw from the
study, such subjects may be withdrawn from the trial and managed by the Principal Investigator
accordingly.
VIII. ROUTINE EXAMINATION AND ASSESSMENT
Screen of the patient will be recorded as per the proforma (Form I). The full details of
history and physical examination of the patients will be recorded as per the proforma (Forms II).
Clinical assessment will be done before treatment, at 15 days of treatment period and at the end of
the treatment as per proforma - III. The laboratory investigations will be carried out before and after
treatment as recorded as proforma - IIIA. Adverse events will berecorded in the proforma - IV.
IX. STATISTICAL ANALYSIS
Data collected will be analyzed using appropriate statistical tools.
X. CRITERIA FOR ASSESSMENT
The assessment of progress & outcome of treatment are assessed on the basis of
improvement in the score of clinical signs and symptoms and laboratory findings and safety
evaluation will be made on the basis of serial recording of the adverse events if any and Liver and
Kidney function tests as PROFORMA II B and III.
XI. TRIAL MONITORING AND STATISTICAL ANALYSIS
Data on clinical symptoms and objective tests before and after the treatment will be
tabulated and analyzed using appropriate statistical tools. However the data of each case will have
to be communicated on completion of trial therapy to the Statistical Officer of CCRAS through e-
mail (ccras_stat@nic.in). The monitoring of progress of the trial will also be undertaken by
CCRAS Hqrs. New Delhi.
XII. ETHICAL REVIEW
A. Institutional Ethical Committee (IEC): The proposal will be placed before Institutional
Ethical Committee (IEC) of trial centre for getting clearance certificate before the project
is initiated. Patient’s information sheet and informed consent form will be submitted along
with project proposal for approval by IEC.
7
B. Data and safety monitoring board: A Data and safety monitoring board (DSMB) at
Hqrs will carefully monitor the data and side effects during the period of study and put in
a place where by prompt reporting of adverse events occur and take appropriate steps in
case of any adverse events occur. The data will be reviewed for every 20 participants
included into the study and administered the trial drugs. The research team will report
immediately to the PI and Data Monitoring Board, any life threatening conditions whether
they are perceived to be study related or not. The Board will decide whether the adverse
effects warrant discontinuation of the study protocol or not. Protocols will be written and
approved for the treatment of study related adverse events about the clinical trial conduct
and laboratory procedures in order to maintain the uniformity.
XIII. TRAVELING EXPENSES FOR RESEARCH SUBJECTS
A consolidated amount of Rs…../- per visit will be paid to each subject as an incentive.
XIV. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
Short-term two-day training will be provided to the Investigators and Laboratory
personnel involved in the multi-centric trial at C.C.R.A.S. Hqrs. and Central Research Institute
(Ay.), New Delhi. The investigators and technicians will be detailed about the clinical trial conduct
and laboratory procedures in order to maintain the uniformity.
XV. LABORATORY INVESTIGATIONS
The Laboratory Investigations (Pathological/Biochemical, etc.), which are not available at
research Institutes should be conducted at identified reputed labs /Government Institutes under
intimation to this Council following codal formalities.
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF THERAPEUTIC EFFICACY & SAFETY OF
VYAGHRIHARITAKI IN THE MANAGEMENT OF KASA (BRONCHITIS)
WRITTEN INFORMED CONSENT FORM
CERTIFICATE BY INVESTIGATOR
I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature of the subject: ______________
Name: ____________________________
CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending physician, the purpose of the
clinical trial and the nature of drug treatment and follow-up, including the laboratory investigations
to be performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so.
I, exercising my free power of choice, hereby give my consent to be included as a subject
in the clinical trial on “Assessment of Therapeutic Efficacy & Safety of Vyaghriharitaki in the
management of Kasa (Bronchitis)
Date:___________ Name of the Subject:_____________________________
Relationship ___________________________________
9
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF THERAPEUTIC EFFICACY & SAFETY OF
VYAGHRIHARITAKI IN THE MANAGEMENT OF KASA (BRONCHITIS)
PATIENT INFORMATION SHEET
10
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF THERAPEUTIC EFFICACY & SAFETY OF
VYAGHRIHARITAKI IN THE MANAGEMENT OF KASA (BRONCHITIS)
CASE REPORT FORM I – SCREENING
BEFORE TREATMENT
(Enter a in the appropriate box)
1. Centre: ………………..……….
6. Address ……………………………………..………………………………………
11
10. Diabetes Mellitus and Hypertension and other
serious cardiovascular disorders.
12
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF THERAPEUTIC EFFICACY & SAFETY OF
VYAGHRIHARITAKI IN THE MANAGEMENT OF KASA (BRONCHITIS)
CASE REPORT FORM II – HISTORY
(Enter a in the appropriate box)
1. Centre: ………………..……….
7. Address ……………………………………..……………..........…………………………
8. Educational status: Illiterate (1) Read and Write(2) Primary School (3)
Chief complaints with duration (in days) Yes (1) No (0) Duration
(in days)
13
12. Sputum - Thick and scanty/Mucoid/
Mucopurulent/Streaks with blood
13. Dyspnoea
14. Wheezing
17. Fever
21. Treatment given so far: Traditional Medicine (1) Modern Medicine (2)
PERSONAL HISTORY
a). Smoking
14
c). Alcohol Yes (1) No (0)
Sannipataj (7)
PHYSICAL EXAMINATION
37. Jaundice
38. Koilonychia
39. Cyanosis
40. Lymphadenopathy
15
SYSTEMIC EXAMINATION
i) Liver
ii) Spleen
43. CNS
SAMPRAPTI (PATHOGENESIS)
16
52. Dushya (Involved) Rasa (1) Rakta(2) Mamsa (3)
Srotas Pareeksha
17
Avipaka (Indigestion) (3)
18
59. Mamsavaha srotas
19
Moorchh (Syncope) (3)
Manovibramsha (1)
Budhivibramsha (2)
Smritivibhramsha (4)
Bhaktivibhramsha (5)
Sheelavibhramsha (6)
Acharavibhramsha (8)
20
Alpaalpa (Scanty urination) (4)
21
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF THERAPEUTIC EFFICACY & SAFETY OF
VYAGHRIHARITAKI IN THE MANAGEMENT OF KASA (BRONCHITIS)
CASE REPORT FORM III - CLINICAL ASSESSMENT
(0, 15, 30 days)
1. Centre: ………………..……….
SYMPTOMS: The following clinical symptoms (Serial no 1-5) along with question on beta
–2 agonist use and another on FEV1% predicted are noted as per ACQ.
1. AIRE (ACQ)* ASTHMA CONTROL QUESTIONN
a. On average, during the past week, how often were you woken by your asthma during the
night?
i. Never (0)
22
ii. Very mild symptoms (1)
c. In general, during the past week, how limited were you in your activities because of your
asthma?
i. Not limited at all (0)
d. In general, during the past week, how much shortness of breath did you experience because
of your asthma?
i. None (0)
e. In general, during t he past week, how much of t he time did your wheeze?
i. Not at all (0)
23
ii. Hardly any of the time (1)
f. On average, during the past week, how many puffs of short-acting bronchodilator (e.g.
Ventorlin) have you used each day?
i. None (0)
24
12. Respiratory rate (per minute)
13. FEVI (Spirometery) —————————————————— (% 0f predicted value)
14. Overall clinical assessment by the Doctor on the basis of ASTHMA CONTROL
QUOTIONNAIRE
Continuing (1)
25
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF THERAPEUTIC EFFICACY & SAFETY OF
VYAGHRIHARITAKI IN THE MANAGEMENT OF KASA (BRONCHITIS)
CASE REPORT FORM IIIA - ADVERSE EVENTS RECORD FORM
(0, 15, 30 days)
1. Centre: ………………..……….
ADVERSE EVENTS
Do the patients have any symptoms with medication in trial groups? Yes (1) No (0)
Please complete all sections & enter l approximate information in numbers in open boxes
1 2 3 4
Adverse
Experience
Date started
Date
26
Time
Date stopped
Pattern
Isolated-1
Intermittent-2
Continuous-3
Severity
Mild-1
Moderate-2
Severe-3
*Mild-No interference with usual activity. *Moderate-Significant interference with usual
activities. *Severe-Prevents usual activities.
Serious*
Yes-1
No-2
Serious ADE is defined as fatal, life-threatening, permanently, disabling requires inpatient
hospitalization or as a congenital anomaly, cancer or overdose. If yes, please till serious
Adverse experiences report form provided. In case of Serious adverse event sponsor should
be informed immediately telephonically.
Relationship to study
medication
Unrelated-1
Possible-2
Probable-3
27
Unrelated: A reaction that does not follow a reasonable temporal sequence from the
administration of the drug; or a known adverse reaction pattern of the suspected drugs
could have been produced by the patients clinical stage, intermittent illness, trauma, accidents
etc:
Possible: follows a reasonable temporal sequence from administration of the drug; follows a
known response pattern to the suspected drug but could have been produced by the patients
clinical stage or other modes of therapy administered to the patients;
Probable: follows a reasonable temporal sequence from administration of the drug; follows a
known response pattern to the suspected drug; that could not be reasonably explained by the
known characteristics of the patients clinical state.
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF THERAPEUTIC EFFICACY & SAFETY OF
VYAGHRIHARITAKI IN THE MANAGEMENT OF KASA (BRONCHITIS)
FORM IV– LABORATORY INVESTIGATIONS
(Before and after the treatment except Sl.No.23 which is to be done at
‘0’ week and Kidney, Liver function tests 0th, 15th and 30th day only)
1. Centre: ………………..……….
Urine Examination
7. Routine____________
8. Microscopic___________
Blood Examination
9. DC: P (%) ________ L (%) ________ E (%) ________ M (%) ________B (%) _______
29
Kidney function tests (Sl.No.14 & 15)
Total
Direct
Indirect
30
ASSESSMENT OF SAFETY AND THERAPEUTIC
EFFICACY OF SHIRISHADI KWATHA IN THE
MANAGEMENT OF MILD PERSISTENT ASTHMA
(TAMAKA SHWASA)
31
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32
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF SAFETY AND THERAPEUTIC EFFICACY OF SHIRISHADI
KWATHA IN THE MANAGEMENT OF MILD PERSISTENT ASTHMA
(TAMAKA SHWASA)
I. BACKGROUND
Tamaka Shwasa1 (Bronchial asthma) is prevalent all over the world. It is characterized
by chronic airway inflammation and increased airway responsiveness resulting in symptoms of
wheeze, cough, chest tightness and dyspnoea. It is also functionally characterized by the airflow
limitations usually reverses spontaneously or with treatment. The available treatment in modern
medical science like bronchodilators, steroids even in the form of inhalers and leukatriens modifiers
have made tremendous success in providing instant or symptomatic relief in Bronchial asthma. But
there is recurrent acute exacerbation and remissions and treatment has many side effects like
nausea, vomiting, tremor, huskiness of voice, disturbance of hypothalamus – pituitary –adrenal axis.
In Ayurveda, Shireeshadi kwatha (3) which has been in practice as well as has shown
anti-asthmatic effect in the clinical studies conducted in BHU, Varanasi & in clinical units of Central
Council for Research in Ayurveda and Siddha, Department of ISM & H, Ministry of Health &
Family Welfare, New Delhi.
The toxicity studies done at the Industrial Toxicology Research Center(CSIR), Lucknow,
December, 2002 report showed no acute and sub-acute toxicity of Shirisadi kwath at the dose of
2500 mg. per Kg. Single dose (acute oral) and 200 ml. per kg. per day (subacute oral 1ml=0.5
mg.) in mice.
References
1. Davidson’s Principle and Practice of Medicine 19th Edition pages 513-521
2. Charaka Samhita, Chikitsa Sthana, Hikka swasha, Chapter–17, Vidyotini Hindi Vyakhya by Pt. Kashinath,
Choukhamba Orientalia, Varanasi
3. Ambika Dutta Sashtri(1989) Susruta samhita (text with Hindi commentary), Uttara Tantra Chapter 51, VIIth
Edition Chaukhamba Sanskrit Series Office, Varanasi.
4. Harrison’s Principle of Internal medicine: 15th Edition pages 1456-1460
5. Annual Reports, P.R.U., Haffkine Institute, Bombay
6. Annual Report, P.R.U., L.H.M.C., New Delhi.
33
II. OBJECTIVE
Primary Objective:
To evaluate the comparative efficacy of Shireeshadi kwatha & sustained-release
theophylline in the mild persistent asthma.
Secondary Objective:
To evaluate the safety of Shireeshadi kwatha in the patients of mild persistent asthma.
III. CENTRE: CCRAS centers in collaboration with other centers
IV. SAMPLE SIZE AND METHODS
Sample Size: 250 (125 patients in each group)
Treatment:
A. Pre-treatment period:
There will be wash out period of two week (any oral bronchodilators should be
withdrawn gradually in both groups and patients in both groups will be allowed to take beta-2
agonist inhalation s.os.).
B. Treatment period:
1. Trial drugs:
i) Shirishadi Kwatha(Decoction)
Shirishadi kwatha (50 gm.) contains Albizzia Lebbeck (Shirish) , Solanum Surattence
(Kantkari), Adhatoda Vasica leaves (Vasa), Hedychium Spicatum (Shati) and equal in quantity.
Method of preparation of decoction: 50 gm. powder should be mixed in 400 ml of
water and reduced to 100 ml. by boiling on low flame and constant stirring. It should then be
filtered.
Dose & Duration: 100 ml in three divided doses daily for ninety days
2. Control Drug: theophylline sustained release tablet.
Dose: 400mg orally after dinner once daily.
Salbutamol inhaler 100 mcg.2 puffs sos is allowed if patient may feel acute
Breathlessness in both groups in pretreatment & treatment period. If patients ave
constipation, patient can take Vyaghri Haritaki 3-6 gm. with lukewarm water.
Design of the study – randomized controlled clinical study.
34
Duration of the study – 3 months drug therapy.
Period of Study: 3 months drug treatment period. Total duration will be 1 years to
complete the trial. Recruitment of the patients up to seven months, treatment period for three
months in both groups and data will be analyzed in next two months.
V. CRITERIA FOR INCLUSION
1. Age between 18 years to 40 years.
2. Both the sexes with equal distribution with or without rhinitis.
3. Mild persistent cases of Asthma (as per WHO GINA Guideline) of duration more than 6
months.
4. Asthmatics who meet reversibility criteria (15% improvement in FEV I after beta-2
agonist inhalation).
5. Symptoms/exacerbation (Wheeze, cough and breathlessness) greater than weekly and less
than daily in frequency.
6. Night symptoms > twice per month but less than once a week.
7. FEV1 > 80% of the predicted value.
8. Never smokers.
VI. CRITERIA FOR EXCLUSION
1. Mild intermittent, Moderated persistent, severe persistent to severe Asthma.
2. FEV<80%.
3. Age below 18 years and more than 40 years
4. Dyspnoea due to other disease like Left ventricular failure, COPD (Chronic Bronchitis,
Emphysema), Upper respiratory tract obstruction, Bronchiectasis, cases of tuberculosis,
interstitial lung disease/occupational Lung disease, tropical pulmonary eosinophilia, Loffler
s disease & Allergic Bronchopulmonary Aspergillosis etc
5. Diabetes Mellitus and Hypertension.
6. Severe renal/Hepatic disease
7. HIV positive cases
8. Pregnant/lactating mother
9. Patient who need Salbutamol inhaler daily.
35
VII. CRITERIA FOR WITHDRAWAL
During the course of the trial treatment, if any serious condition or any serious adverse
events which requires urgent treatment or if patients himself want to withdraw from the study, such
subjects may be withdrawn from the trial and managed by the Principal Investigator accordingly.
VIII. ROUTINE EXAMINATION AND ASSESSMENT
The full details of history and physical examination of the patients will be recorded as per the
proforma (Forms I & IA). Clinical and physiological assessment will be done before treatment
and fortnightly during treatment period and at the end of the treatment. The laboratory
investigations will be carried out as per recorded in the proforma.
IX. STATISTICAL ANALYSIS
Data collected on scores of ACQ (ANNEX-1) & VAS (ANNEX-2) based on which
progress of treatment will be analyzed using appropriate statistical tools.
X. CRITERIA FOR ASSESSMENT
The assessment of progress & outcome of treatment are assessed on the basis of
improvement in the score of ASTHMA CONTROL QUESTIONNAIRE (Anexxure-1) and VAS
(ANNEX-2) and safety evaluation will be made on the basis of serial recording of the adverse
events and Liver and Kidney function tests as per recorded in the proforma II B and III.
XI. TRIAL MONITORING AND DATA ANALYSES
The monitoring of progress of the trial and data analysis will be undertaken by CCRAS,
Hqrs., New Delhi.
XII. ETHICAL REVIEW
Each Institutional Ethical Committee (IEC) of participating Center’s should give clearance
certificate before the project is initiated. Patient’s information sheet and informed consent form
should be submitted along with project proposal for approval by IEC. Both should be maintained
in duplicate with one copy given to the patient at the time of entry to the trial. The study will be
conducted in accordance with Good Clinical Practice. This incorporates principles laid down in
the Declaration of Helsinki.
XIII. TRAVELING EXPENSES FOR RESEARCH SUBJECTS
A consolidated amount of Rs…../- per visit i.e., on the 1st day of recruitment after
screening, 15th, 30th, 45th, 60th, 75th and 90th days (7 times).
XIV. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
Short-term two-day training will be provided to the Investigators and Laboratory
36
personnel involved in the multi-centric trial at CCRAS Hqrs. and Central Research Institute (Ay.),
New Delhi. The investigators and technicians will be detailed about the clinical trial conduct and
laboratory procedures in order to maintain the uniformity.
XV. LABORATORY INVESTIGATIONS
The Laboratory Investigations (Pathological/Biochemical, etc.), which are not available at
research Institutes should be conducted at identified reputed labs /Government Institutes under
intimation to this Council following codal formalities.
37
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
WRITTEN INFORMED CONSENT FORM
CERTIFICATE BY INVESTIGATOR
I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature of the subject: ______________
Name: ____________________________
CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending physician, the purpose of the
clinical trial and the nature of drug treatment and follow-up, including the laboratory investigations
to be performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so.
I, exercising my free power of choice, hereby give my consent to be included as a subject
in the clinical trial on “Assessment of Safety & Therapeutic Efficacy of Shireeshadi kwatha in the
management of Mild Persistent Asthma (Tamaka Swasa).
Relationship ___________________________________
38
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF SAFETY& THERAPEUTIC EFFICACY OF SHIRISHADI
KWATHA IN THE MANAGEMENT OF MILD PERSISTENT ASTHMA
(TAMAKA SWASA)
PATIENT INFORMATION SHEET
39
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF SAFETY& THERAPEUTIC EFFICACY OF SHIRISHADI
KWATHA IN THE MANAGEMENT OF MILD PERSISTENT ASTHMA
(TAMAKA SWASA)
CASE REPORT FORM I - SCREENING
BEFORE TREATMENT
(Enter a in the appropriate box)
1. Centre: ………………..……….
6. Address Permanent postal address with phone number and email if any.
_______________________________________________________________________
_______________________________________________________________________
40
14. Ever smoker.
16. FEV<80%
41
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF SAFETY& THERAPEUTIC EFFICACY OF SHIRISHADI
KWATHA IN THE MANAGEMENT OF MILD PERSISTENT ASTHMA
(TAMAKA SWASA)
CASE REPORT FORM II – HISTORY
(Enter a in the appropriate box)
1. Centre: ………………..……….
7. Educational status: Illiterate (1) Read and Write(2) Primary School (3)
42
11. Paroxysm of breathlessness
12. Wheezing
13. Cough
a). Breathlessness,
b). Wheezing
1. Sneezing
2. Running nose
3. Blocked nose
43
Treatment History
Personal History:
History of Environmental
44
30. Tobacco chewing
Occasional (1) : 1
Regular (2) : 2
Never (3) : 3
33. Prakriti:
Sama (7)
Physical Examination
36. B.M.I
{ Weight (kg.)
Height (meters) 2 } ____________
45
43. Edema ____________
44. Pallor
45. Lymphadenopathy
(Area)__________
Systemic Examination
Shape of chest:
Auscultation
If abnormal, details____________________________________________
46
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF SAFETY& THERAPEUTIC EFFICACY OF SHIRISHADI
KWATHA IN THE MANAGEMENT OF MILD PERSISTENT ASTHMA
(TAMAKA SWASA)
FORM III -CLINICAL AND PHYSIOLOGICAL ASSESSMENT
(0, 15, 30, 45, 60, 75, 90 days)
1. Centre: ………………..……….
7. Address Permanent postal address with phone number and email if any.
_______________________________________________________________________
_______________________________________________________________________
SYMPTOMS: The following clinical symptoms (Serial no 1-5) along with question on beta
–2 agonist use and another on FEV1% predicted are noted as per ACQ.
a. On average, during the past week, how often were you woken by your asthma during the
night?
i. Never (0)
47
vii. Unable to sleep because of asthma’ (6)
b. On average, during the past week, how bad were your asthma symptoms when you wok up
in the morning?
i. No symptoms (0)
c. In general, during the past week, how limited were you in your activities because of your
asthma?
d. In general, during the past week, how much shortness of breath did you experience because
of your asthma?
i. None (0)
48
iv. Quite a lot (3)
e. In general, during the past week, how much of the time did your wheeze?
f. On average, during the past week, how many puffs of short-acting bronchodilator (e.g.
Ventorlin) have you used each day?
i. None (0)
1 95-90%
3 79-70%
49
FEV1 % predicted………………………...... 4 69-60%
5 59-50%
6 <50% predicted
9. a. Blood pressure
i. Systolic (mmHg.)
c. Temperature
(% 0f predicted value)
10. Overall clinical assessment by the Doctor on the basis of ASTHMA CONTROL
QUOTIONNAIRE
50
12. Overall impression of well-being by the Subject:
Continuing (1)
51
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF SAFETY& THERAPEUTIC EFFICACY OF SHIRISHADI
KWATHA IN THE MANAGEMENT OF MILD PERSISTENT ASTHMA
(TAMAKA SWASA)
CASE REPORT FORM III A - ADVERSE EVENTS RECORD
(0, 15, 30, 45, 60, 75, 90 days)
1. Centre: ………………..……….
7. Address Permanent postal address with phone number and email if any.
_______________________________________________________________________
_______________________________________________________________________
ADVERSE EVENTS
8. Does the patient have any symptoms with medication in trial group? Yes(1) No(0)
Please complete all sections & enter l approximate information in numbers in open boxes
1 2 3 4
Adverse
Experience
52
Date started
Date
Time
Date stopped
Pattern
Isolated-1
Intermittent-2
Continuous-3
Severity
Mild-1
Moderate-2
Severe-3
Serious*
Yes-1
No-2
53
Relationship
to study
medication
Unrelated-1
Possible-2
Probable-3
Unrelated: A reaction that does not follow a reasonable temporal sequence from the
administration of the drug; or a known adverse reaction pattern of the suspected drugs could
have been produced by the patients clinical stage, intermittent illness, trauma, accidents etc:
Possible: follows a reasonable temporal sequence from administration of the drug; follows a
known response pattern to the suspected drug but could have been produced by the patients
clinical stage or other modes of therapy administered to the patients;
Probable: follows a reasonable temporal sequence from administration of the drug; follows a
known response pattern to the suspected drug; that could not be reasonably explained by the
known characteristics of the patient's clinical state.
54
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF SAFETY& THERAPEUTIC EFFICACY OF SHIRISHADI
KWATHA IN THE MANAGEMENT OF MILD PERSISTENT ASTHMA
(TAMAKA SWASA)
CASE REPORT FORM IV – LABORATORY INVESTIGATIONS
(Before and after the treatment except Sl.No.23 which is to be done at ‘O’
week and Kidney, Liver function tests O, 6th and 12th week only.)
1. Centre: ………………..……….
7. Urine Examination
Routine____________ Microscopic___________
8. C (Cells/Cmm.)_____________________
55
Kidney function tests (Sl.No.14 & 15)
21. S. Bilirubin(mg./dL)
Total: ___________
Direct: ___________
Indirect: ___________
Place: ……………
56
PROTOCOL FOR ASSESSMENT OF THERAPEUTIC EFFICACY OF
SHIRISHADI KWATHA IN THE MANAGEMENT OF TAMAKA SHWASA
(BRONCHIAL ASTHMA)
Annexure-1: ASTHMA CONTROL QUESTIONNAIRE 1
SYMPTOMS: The following clinical symptoms (Serial no 1-5) alongwith question on beta –2
agonist use and another on FEV1% predicted are noted as per ACQ.
57
1 Very slightly limited (1)
2 Slightly limited (2)
3 Moderately limited (3)
4 Very limited (4)
5 Extremely limited (5)
6 Total limited (6)
4. In general, during the past week, how much shortness of breath did experience because of
your asthma?
0. None (0)
1. A very little (1)
2. A moderate amount (2)
3. Quite a lot (3)
4. A great deal (4)
5. A very great deal (5)
5. In general, during the past week, how much of the time did your wheeze?
0. Not at all (0)
1. Hardly any of the time (1)
2. A moderate amount of the time (2)
3. A lot of the time (3)
4. Most of the time (4)
5. All the time. (5)
6. On average, during the past week, how many puffs of short-acting bronchodilator (e.g.
Ventorlin) have you used each day?
0. None (0)
1. 1-2 puffs most days (1)
2. 3-4 puffs most days (2)
3. 5-8 puffs most days (3)
4. 9-12 puffs most days (4)
58
5. 13-16 puffs most days (5)
6. More than 16 puffs most days.
To be completed by a member of the clinic staff.
7. FEV1 prebronchodilator……………...... 0 > 95% predicted
1 95-90%
FEV1 % predicted…….……….....… 2 89-80%
3 79-70%
FEV1 % predicted………………...... 4 69-60%
5 59-50%
6 < 50% predicted
Patients are asked to recall their symptoms & short-acting beta-2 agonist use during the previous
week. All seven questions as mentioned in ACQ are scored on a seven point scale (0=good
control,6=poor control) ,and the overall score is the mean of seven responses.
1: Elizabeth F.Juniper, Paul M et al. Am J Respir Crit Care Med Vol 162 pp1330-34, 2000
59
PROTOCOL FOR ASSESSMENT OF THERAPEUTIC EFFICACY OF
SHIRISHADI KWATHA IN THE MANAGEMENT OF TAMAKA SHWASA
(BRONCHIAL ASTHMA)
Annexure-II
References
1. J. Asthma 2003; 40:27-39
2. National Heart, Lung, and Blood Institute, Publication No.97-4051, Expert Panel Report II, 1997.
60
GASTRO INTESTINAL SYSTEM
SECTION - II
61
Blank
62
CLINICAL VALIDATION OF BILWAMAJJA CHURNA
IN KAPHAJA PRAVAHIKA (IBS)
63
Blank
64
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL VALIDATION OF BILWAMAJJA CHURNA IN KAPHAJA
PRAVAHIKA (IBS)
I. BACKGROUND
Kaphaja Pravahika1 (vis-à-vis Irritable bowel syndrome) is a disease of the
Purishavaha srotas, caused due to excessive intake of unctuous and heavy foods and is
characterised by the association of excessive mucous in the stool along with abdominal pain,
discomfort and bloating.
According to allopathic system of medicine Irritable bowel syndrome (IBS) is a blanket
term for a variety of diseases causing discomfort in the gastro-intestinal tract. It is a functional
bowel disorder characterized by chronic abdominal pain, discomfort, bloating, and alteration of
bowel habits in the absence of any organic cause. In some cases, the symptoms are relieved by
bowel movements. Certain psychological conditions are also more common in those with IBS.
Treatments for IBS includes attempt to relieve symptoms, including dietary adjustments, medication
and psychological interventions. Patient education and a good doctor-patient relationship are also
important.
Owing to the complications and adverse effects of current modern medication to manage
such condition, need is felt for search of safe /effective Ayurvedic oral dosage forms with scientific
parameters. Keeping the gravity of the situation and the public health needs in view, the council has
initiated scientific studies on Bilwamajja Churna, a promising herbal drug that is being successfully
prescribed by Ayurvedic physicians without any side effects since centuries in Kaphaja Pravahika
(IBS).
II. OBJECTIVE
To assess the effect of Bilwamajja Churna in reducing the signs and symptoms of Kaphaja
Pravahika (IBS)
References
1. Charaka Samhita, Chikitsa Sthana, Chapter–17, Vidyotini Hindi Vyakhya by Pt. Kashinath, Choukhamba
Orientalia, Varanasi
2. Ambika Dutta Sashtri (1989), Susruta samhita (text with Hindi commentary), Uttara Tantra Chapter 40,
VIIth Edition Chaukhamba Sanskrit Series Office, Varanasi.
3. Harrison’s Principle of Internal medicine: 17th Edition, Vol – 1, Page: 970
65
III. CENTERS
CCRAS identified Centers
IV. SAMPLE SIZE AND METHODS
No. of Groups : One
Sample size : 30 Subjects per center
Trial Drug /Dosage /Duration : Bilwamajja churna 3 gms twice daily after
food for 30 days with warm water for 30
days and follow-up for another 15 days
without medicine.
Design of the study : Open trial
Total period of the study : One year
Follow up study: : For a period of 15 days at the interval of
7 days after completion of the therapy.
V. CRITERIA FOR INCLUSION
1. Age between 15 and 60 years
2. History of frequent passing of little quantity of stool along with mucous and tenesmus.
3. The frequency of passing of stool should be 3 times or more in 24 hours.
4. Stool examination should be positive either with E.H. cyst or E.coli or both.
VI. CRITERIA FOR EXCLUSION
1. Age below 15 years and above 60 years.
2. Stool test negative for E.H. cyst and/or E.coli.
3. Mixed infection with other parasites like round worms, hook worms etc.
4. Complicated with tuberculosis, malignancy or hepatic abscess.
5. Associated with other grave systemic diseases like cardiac disorders, jaundice, diabetes
mellitus etc.
VII. CRITERIA FOR WITHDRAWAL
During the course of the trial, if any serious condition or any serious adverse events which
requires urgent treatment or if subjects themselves want to withdraw from the study, such subjects
may be withdrawn from the trial.
66
VIII. ROUTINE EXAMINATION AND ASSESSMENT
The full details of screening and history along with physical examination of the subjects will
be recorded as per case report form I & II respectively. Clinical and physiological assessment in
form III and laboratory investigations in form IV will be done at 0, 15th & 30th days.
Consolidated data on periodical observation will be recorded in case report form-V.
IX. ASSESSMENT CRITERIA :
67
X. STATISTICAL ANALYSIS:
Data on clinical symptoms and objective tests before and after the treatment will be
tabulated and analyzed using appropriate statistical tools. However the data of each case will have
to be communicated on completion of trial therapy to the Statistical Officer of CCRAS through e-
mail (ccras_stat@nic.in).
XI. TRIAL MONITORING AND DATA ANALYSIS:
CCRAS, Hqrs, New Delhi will undertake the monitoring of progress of the trial and data
analysis.
XII. ETHICAL REVIEW:
A. Institutional Ethical Committee (IEC): The proposal will be placed before
Institutional Ethical Committee (IEC) of trial center for getting clearance certificate before the
project is initiated. Patient’s information sheet and informed consent form will be submitted along
with project proposal for approval by IEC.
B. Data and safety monitoring board: A Data and safety monitoring board (DSMB)
at Hqrs will carefully monitor the data and side effects during the period of study and put in a
place where by prompt reporting of adverse events occur and take appropriate steps in case of
any adverse events occur. The data will be reviewed for every 20 participants included into the
study and administered the trial drugs. The research team will report immediately to the PI and
Data Monitoring Board, any life threatening conditions whether they are perceived to be study
related or not. The Board decides whether the adverse effects warrant discontinuation of the study
protocol. Protocols will be written and approved for the treatment of study related adverse events
about the clinical trial conduct and laboratory procedures in order to maintain the uniformity.
XIII. TRAVELING EXPENSES FOR RESEARCH SUBJECTS
A consolidated amount of Rs……./- per visit will be paid to subject selected in the study.
XIV. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
Short-term two-day training will be provided to the Investigators and Laboratory
personnel involved in the multicentric trial at CCRAS Hqrs. and Central Research Institute (Ay.),
New Delhi. The investigators and technicians will be detailed about the clinical trial conduct and
laboratory procedures in order to maintain the uniformity.
XV. LABORATORY INVESTIGATIONS
1. Stool:
Routine & Microscopic
E.H. Cyst & E. Coli
68
Mucous
Occult blood
Ingested Vegetable particles
2. Urine:
Routine & Microscopic
3. Blood:
TLC
DC
Hb%
ESR
FBS
Mx Test
69
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL VALIDATION OF BILWAMAJJA CHURNA IN KAPHAJA
PRAVAHIKA (IBS)
WRITTEN INFORMED CONSENT FORM
CERTIFICATE BY INVESTIGATOR
I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature of the subject: ______________
Name: ____________________________
CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending physician about the purpose of
the clinical trial and the nature of drug treatment and follow-up, including the laboratory
investigations to be performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so. I am willing to undergo any risk for inclusion in
this study.
I, exercising my free power of choice, hereby give my consent to be included as a subject
in the “Clinical validation of bilwamajja churna in kaphaja pravahika (IBS)”
Relationship ___________________________________
70
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL VALIDATION OF BILWAMAJJA CHURNA IN KAPHAJA
PRAVAHIKA (IBS)
PATIENT INFORMATION SHEET
71
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL VALIDATION OF BILWAMAJJA CHURNA IN KAPHAJA
PRAVAHIKA (IBS)
CASE REPORT FORM I – SCREENING
BEFORE TREATMENT
(Enter a in the appropriate box)
1. Centre: ………………..……….
6. Address ……………………………………..………………………………………
7. E. Coli or both
72
10. Mixed infection with other parasites like round worms,
hook worms etc
73
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF THERAPEUTIC EFFICACY & SAFETY OF
VYAGHRIHARITAKI IN THE MANAGEMENT OF KASA (BRONCHITIS)
CASE REPORT FORM II – HISTORY
(Enter a in the appropriate box)
1. Centre: ………………..……….
7. Address ……………………………………..……………..........…………………………
8. Educational status: Illiterate (1) Read and Write(2) Primary School (3)
Less than Rs.60, 000/- (1) More than Rs.60, 000/- (2)
74
Chief complaints with duration (in days) Yes (1) No (0) Duration
(in days)
14. Tenesmus
17. Bloating
PERSONAL HISTORY
Sannipataj (7)
75
28. Manasa Prakriti: Sattva (1) Rajas (2) Tamas (3)
Sama (7)
PHYSICAL EXAMINATION
36. Pallor
37. Jaundice
38. Koilonychia
39. Lymphadenopathy
SYSTEMIC EXAMINATION
41. CNS
76
42. CVS with chest
i) Liver
ii) Spleen
Normal Abnormal
SAMPRAPTI (PATHOGENESIS)
Mutravaha(7)
77
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL VALIDATION OF BILWAMAJJA CHURNA IN KAPHAJA
PRAVAHIKA (IBS)
CASE REPORT FORM III -PERIODICAL OBSERVATION AND CLINICAL
ASSESSMENT
(On Day 0, 7th, 15th, 30th day)
Separate form should be used on each visit
(Enter a in the appropriate box)
1. Centre: ………………..……….
Chief complaints with duration (in days) Yes (1) No (0) if yes, Duration
(in days)
7. Tenesmus
9. Abdominal pain
10. Bloating
78
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL VALIDATION OF BILWAMAJJA CHURNA IN KAPHAJA
PRAVAHIKA (IBS)
(On Day 0, 7th, 15th, 30th day)
CASE REPORT FORM IV-PERIODICAL OBSERVATION AND LABORATORY
ASSESSMENT
(Enter a in the appropriate box)
1. Centre: ………………..……….
7. Date of Assessment
8. Stool examination
Routine Microscopic
Ova/Cyst
Mucous,
Vegitative cells
9. Urine Examination
Routine Microscopic
Blood
11. DC: P _____ (%) L _____ (%) E ______ (%) M _____ (%) B ______(%)
79
12. ESR (mm / 1st hour.) __________
14. S. Bilirubin
• Total (mg/dl)
• Direct (mg/dl)
• Albumin (g/dl)
• Globulin (g/dl)
Specific Investigations:
22. Mx Test
23. FBS
80
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL VALIDATION OF BILWAMAJJA CHURNA IN KAPHAJA
PRAVAHIKA (IBS)
CASE REPORT FORM V-CONSOLIDATED DATA ON PERIODICAL
OBSERVATIONS
(Enter a in the appropriate box)
1. Centre: ………………..……….
7. Date of Assessment
81
Diarrhoea Not applicable
Skin rashes Not applicable
8. TC (Cells/Cu. mm.) Not applicable
9. DCLLLL P _____% P _____% P _____%
L _____% Not L _____% L _____%
E _____% applicable E _____% E _____%
10. ESR (mm / 1st hour.) Not
applicable
a. Total
(mg/dl) Not Not
b. Direct applicable applicable
(mg/dl)
14. SGPT (IU/L)
15. SGOT (IU/L)
16. S. Alkaline
phosphatase
(U/L)
17. S. Proteins
(Total) (g/dl)
18. Albumin (g/dl)
19. Globulin (g/dl)
20. Renal function
tests
21. Blood urea Not Not
(mg/dl) applicable applicable
82
22. S. Creatinine
(mg/dl)
23. Urine
Examination
Routine Not
applicable
Microscopic Not
applicable
24. Stool
Examination
Occult Blood Not Not
applicable applicable
Ova/Cyst Not Not
applicable applicable
Mucous Not Not
applicable applicable
Vegetative Not Not
cells applicable applicable
Completed (1)
83
Blank
84
MULTICENTRIC OPEN CLINICAL TRIAL OF
PALASABEEJA CHURNA IN KRIMI ROGA
(GANDUPADA KRIMI)
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC OPEN CLINICAL TRIAL OF PALASABEEJA CHURNA IN
KRIMI ROGA (GANDUPADA KRIMI)
I. BACKGROUND
Krimi Roga (Intestinal nematode infections)1 is the most common ailment which affect one
fourth to one third of the world’s population. Of these, the Gandupada Krimi (intestinal
roundworm-Ascaris lumbricoides) is the most common. Worldwide, 1.4 billion people are
infected with a lumbricoides. While the vast majority of these cases are asymptomatic, infected
persons may present with pulmonary or gastrointestinal complaints.
The rate of complications secondary to Ascariasis ranges from 11-67%, with intestinal and
biliary tract obstruction representing the most common serious sequelae. Although infection with A
lumbricoides is rarely fatal, it is responsible for an estimated 8,000-100,000 deaths annually,
mainly in children. Ascariasis predominates in areas of poor sanitation and is associated with
malnutrition, iron-deficiency anemia, and impairments of growth and cognition.
Owing to the gravity of the signs, symptoms and rate of complications caused by Ascaris,
it is need to explore and re-establish the efficacy of classical drug Palashbeeja Churna in oral
dosage form to treat the patients affected with Gandupada Krimi (A lumbricoides).
II. OBJECTIVES
1) To see the clinical efficacy of Palashbeeja Churna in the management of Gandupada
Krimi Roga (Ascariasis).
2) Observe the clinical safety of Palashbeeja Churna in the subjects affected by the
Gandupada Krimi (A lumbricoides).
References
1. Charaka Samhita, Vimana Sthana Chapter– 7, Vidyotini Hindi Vyakhya by Vd. Ambikadatta Shastry,
Choukhamba Orientalia, Varanasi
2. Harisson’s Principles of internal medicine, Volume-1, 14th Edition, International Editions, 1998, Published
by McGraw-Hill CompaniesInc.pp1208-1209
3. Davidson’s Principles and practice of Medicine, 18th Edition, 1999, Published by Harcourt Brace and
Company, pp173-174
4. Diagnosis and Treatment of diseases in Ayurveda based on Ayurveda saukhyam of Todaranand, Part-II
by Bhagawan Dash & Lalit Kashyap, 1982, pp-286
5. Bhaisajya Ratnavali, Krimiroga Chikitsa Prakarana, Chaukhamba Sanskrit Samsthan, Varanasi
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III. CENTRE
Identified CCRAS Institutes.
IV. SAMPLE SIZE AND METHODS
Sample size : 40 subjects per centre
Trial Drug /Dosage /Duration : Palashbeeja Churna 750 mg-3 gm
(Dragee form) twice daily before meal for
fifteen (15) days with honey.
Design of the study : Open observational
Total period of the study : 1 year (recruitment of Subjects up to the
end of 6th Month, continuation of trial
therapy till end of 8th Month, last 4
months for compilation of data and
Statistical analysis)
V. CRITERIA FOR INCLUSION
1. Age between 5 to 20 years of either sex.
2. Presence of signs and symptoms caused by A. lumbricoids
3. Positive ova of Ascaris in the stool
4. No history of other parasitic infestation
VI. CRITERIA FOR EXCLUSION
1. Age less than 5 years and more than 20 years.
2. Negative ova of Ascaris in the stool
3. Other parasitic infestation like hook worm, giardia, EH cyst, etc.
4. Any concomitant disorder of the liver, kidneys, heart, lungs or others
VII. CRITERIA FOR WITHDRAWAL
During the course of the trial treatment, if any serious condition or any serious adverse
events which requires urgent treatment or if patients himself want to withdraw from the study, such
subjects may be withdrawn from the trial.
VIII. ROUTINE EXAMINATION AND ASSESSMENT
The full details of screening, history and physical examination of the subjects will be
recorded as per case report form I & II. Clinical and physiological assessment in form III and
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laboratory investigations in forms IV A, B, C will be done at 0, 8th & 15th days respectively.
Consolidated data on periodical observation will be recorded in case Report form V at 15th day.
IX. CRITERIA FOR ASSESSMENT
Changes in the signs and symptoms and absence of ova of Ascaris will be considered for
assessing the outcome of the treatment on 8th and 15th day. The safety parameters (liver and kidney
function) will be assessed at 0 and 45th day.
X. STATISTICAL ANALYSIS:
Data on clinical symptoms and objective tests before and after the treatment will be
tabulated and analyzed using appropriate statistical tools. However, the data of each case will have
to be communicated on completion of trial therapy to the Statistical Officer of CCRAS through e-
mail.
XI. TRIAL MONITORING AND DATA ANALYSIS:
CCRAS, Hqrs, New Delhi will undertake the monitoring of progress of the trial and data
analysis.
XII. ETHICAL REVIEW
A. Ethical Committee (IEC): The proposal will be placed before Ethical Committee
(IEC) of trial center for getting clearance certificate before the project is initiated. Patient’s
information sheet and informed consent form will be submitted along with project proposal for
approval by EC. Both will be maintained in duplicate with one copy given to the patient at the
time of entry to the trial.
B. Data and safety monitoring board: A Data and safety monitoring board (DSMB)
at Hqrs. will carefully monitor the data and side effects during the period of study and put in a
place where by prompt reporting of adverse events occur. The data will be reviewed as every 20
participants entered the study and administered the trial drugs. The research team will report
immediately to the PI and Data Monitoring Board if, any life threatening conditions whether they
are perceived to be study related or not. The Board decides whether the adverse effects warrant
discontinuation of the study protocol. Protocols will be written and approved for the treatment of
study related adverse events.
XIII. TRAVELING EXPENSES FOR RESEARCH SUBJECTS
A consolidated amount of Rs.100/- per visit i.e., on the 1st day of recruitment after
screening, 8th day, and 15th day. (3 times)
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XIV. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
Short-term two-day training will be provided to the Investigators and Laboratory
personnel involved in the multi-centric trial at CCRAS Hqrs. and Central Research Institute (Ay.),
New Delhi. The investigators and technicians will be detailed about the clinical trial conduct and
laboratory procedures in order to maintain the uniformity.
XV. LABORATORY INVESTIGATIONS
The Laboratory Investigations (Pathological/Biochemical, etc.), which are not available at
research Institutes should be conducted at identified reputed labs /Government Institutes under
intimation to this Council following codal formalities.
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC OPEN CLINICAL TRIAL OF PALASABEEJA CHURNA IN
KRIMI ROGA (GANDUPADA KRIMI)
WRITTEN INFORMED CONSENT FORM
CERTIFICATE BY INVESTIGATOR
I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature of the subject: ______________
Name: ____________________________
CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending physician, the purpose of the
clinical trial and the nature of drug treatment and follow-up, including the laboratory investigations
to be performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so. I am willing to undergo any risk for inclusion in
this study.
I, exercising my free power of choice, hereby give my consent to be included as a subject
in the clinical trial on “Multicentric open Clinical trial of Palasabeeja Churna in Krimi Roga
(Gandupada Krimi)”.
Relationship ___________________________________
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC OPEN CLINICAL TRIAL OF PALASABEEJA CHURNA IN
KRIMI ROGA (GANDUPADA KRIMI)
PATIENT INFORMATION SHEET
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC OPEN CLINICAL TRIAL OF PALASABEEJA CHURNA IN
KRIMI ROGA (GANDUPADA KRIMI)
CASE REPORT FORM I – SCREENING
BEFORE TREATMENT
(Enter a in the appropriate box)
1. Centre: ………………..……….
6. Address ……………………………………..………………………………………
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A patient is eligible for admission to the trail
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF THERAPEUTIC EFFICACY & SAFETY OF
VYAGHRIHARITAKI IN THE MANAGEMENT OF KASA (BRONCHITIS)
CASE REPORT FORM II – HISTORY
(Enter a in the appropriate box)
1. Centre: ………………..……….
7. Address: Permanent postal address with phone number & E-mail if any.
..............................................................................................................................................
..............................................................................................................................................
8. Educational status: Illiterate (1) Read and Write(2) Primary School (3)
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12. HISTORY OF PRESENT ILLNESS:
Chief complaints with duration (in days) Yes (1) No (0) Duration
(in days)
a) Jvara (Fever)
b) Vivarnata (Discoloration)
d) Hridroga(Cardiac disorders)
e) Sadana(Fatigue)
f) Bhrama(Giddiness)
g) Bhaktadwesha (Anorexia)
h) Atisara (Diarrhoea)
j) Hrillasa (Nausia)
k) Avipaka (Indigestion)
l) Anaha (Tympanitis)
m) Karshya (Cachexia)
p) Duration of disease
a) Smoking
b) Non-Vegetarian diet
c) Alcoholic
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c. Sharirika Prakriti: Vata (1) Pitta (2) Kapha (3)
Sannipataj (7)
h) Pallor
i) Jaundice
j) Koilonychia
k) Lymphadenopathy
b) CNS
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c) Digestive system
d) Uro-genital system
e) Respiratory system
i) Liver
ii) Spleen
a) Anubandhya dosha
b) Anubandh dosha
c) Avaraka dosha
d) Ksheen dosha
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC OPEN CLINICAL TRIAL OF PALASABEEJA CHURNA IN
KRIMI ROGA (GANDUPADA KRIMI)
CASE REPORT FORM III -PERIODICAL OBSERVATION AND ASSESSMENT
(On Day 0, 8th, and 15th)
Separate form should be used on each visit
(Enter a in the appropriate box)
1. Centre: ………………..……….
Chief complaints with duration (in days) Yes (1) No (0) Duration
(in days)
8. Jvara (Fever)
9. Vivarnata (Discoloration)
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16. Swasakrichhrata (Dyspnea)
ii. Nausea
iii. Diarrhoea
Continuing (1)
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC OPEN CLINICAL TRIAL OF PALASABEEJA CHURNA IN
KRIMI ROGA (GANDUPADA KRIMI)
(On Day 0)
FORM IV-A – LABORATORY INVESTIGATIONS
(Enter a in the appropriate box)
1. Centre: ………………..……….
Urine Examination
8. Routine: _____________
9. Microscopic: ______________
Stool examination:
Blood
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15. DC - P _____ (%) L _____ (%) E ______ (%) M _____ (%) B ______(%)
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC OPEN CLINICAL TRIAL OF PALASABEEJA CHURNA IN
KRIMI ROGA (GANDUPADA KRIMI)
(On Day 08)
FORM IV-B – LABORATORY INVESTIGATIONS
(Enter a in the appropriate box)
1. Centre: ………………..……….
Stool:
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC OPEN CLINICAL TRIAL OF PALASABEEJA CHURNA IN
KRIMI ROGA (GANDUPADA KRIMI)
(On Day 15)
FORM IV-C – LABORATORY INVESTIGATIONS
(Enter a in the appropriate box)
1. Centre: ………………..……….
Urine Examination
8. Routine: _________________________________
9. Microscopic: _________________________________
Stool examination
Blood
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15. DC - P _____ (%) L _____ (%) E ______ (%) M _____ (%) B ______(%)
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC OPEN CLINICAL TRIAL OF PALASABEEJA CHURNA IN
KRIMI ROGA (GANDUPADA KRIMI)
CASE REPORT FORM V-CONSOLIDATED DATA ON PERIODICAL
OBSERVATIONS
(Enter a in the appropriate box)
1. Centre: ………………..……….
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12. Anaha (Tympanitis)
13 Karshya (Cachexia)
14. Adverse reaction
Burning sensation in abdomen
Nausea
Diarrhoea
Skin rashes
Any other
15. TC (Cells/Cmm.)
16. DC P _____% P _____% P _____%
L _____% L _____% L _____%
E _____% E _____% E _____%
M _____% M _____% M _____%
B _____% B _____% B _____%
17. ESR (mm / 1st hour.)
18. Hb(g/dl)
19. Ova(A. lumbricoids) in the
stool
20. Liver function tests
S. Bilirubin (mg/dl)
SGPT (IU/L)
SGOT (IU/L)
S. Alkaline phosphatase
(KA unit)
S. Proteins (gm/dl)
21. Renal function tests
Blood urea (mg/dl)
S. Creatinine (mg/dl)
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Overall clinical assessment
Continuing (1)
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CLINICAL EVALUATION OF VIJAURA NIBU SWARAS
ALONGWITH SAINDHAVA, KALAMI SHORA AND
NAUSADARA IN ONE GROUP VIS-A-VIS PATHAR
CHATTI SWARAS ALONGWITH IKSHUARAKA AND
KALI MIRCH IN THE MANAGEMENT OF
PITTASHMARI (GALL STONE)
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF VIJAURA NIBU SWARAS ALONG WITH
SAINDHAVA, KALAMI SHORA AND NAUSADARA IN ONE GROUP VIS-A-VIS
PATHAR CHATTI SWARAS ALONG WITH IKSHUARAKA AND KALI MIRCH
IN THE MANAGEMENT OF PITTASHMARI (GALL STONE)
I. BACKGROUND
Ayurvedic literature describes ‘Ashmari’ primarily as a disease of urinary tract. Vataj, Pittaj,
Kaphaj and Shukraj these four types of Ashmaris are described in general. No specific etiology or
treatment has been mentioned Pittashmaris. However, the existence of ‘Pitteshu Iva Rochna go’ is
considered Sushruta in Nidana Sthana Chapter III and Chikitsa Sthana Chapter VII describes
Ashmaris etiology and treatment respectively. The entire description belongs to the Ashmaris or
urinary tracts. Gall stones are usually found in the gall bladder, but in 20 percent of cases, stones
may be present in the bile duct. Most of the times, it is the one sone amongst which is
responsible for patient’s sufferings (Bailey & Love’s)1.
The factors responsible for the formation of gall stones may be:
- Metabolic
- Infective
- Bile Stone
The effects and complications of gall stones may be:
(i) Stone in gall bladder
- Silent stones
- Flatulent dyspepsia
- Gall stone colic
- Acute cholecystitis
References
1. Harisson’s Principles of internal medicine, Volume-1, 14 th Edition, International Editions, 1998,
Published by McGraw-Hill Companies Inc .pp1208-1209
2. Bhaisajya Ratnavali, Krimiroga Chikitsa Prakarana, Chaukhamba Sanskrit Samsthan, Varanasi
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- Chronic cholecystitis
- Carcinoma
(ii) In the bile ducts
- Obstructive jaundice
- Acute/recurrent poncreatitis
- Cholangitis
(iii) In the intestine
- Acute intestinal obstruction
TYPE OF GALL STONES
The gall stones may be:
- Cholesterol
- Pigment stones (12% of gall stones)
- Mixed stones (majority 80-82% of gall stones)
A fat fertile, female of forty is an easy victim to the disease.
The incidence of gall-stone rises with diabetes mellitus, raised serum triglycerides,
pregnancy, obesity, patients taking clofibrate, oestrogen replacement therapy and contraceptive
pills. Patients with cirrhosis liver and hemolytic anemia have more chances of pigment stones.
Modern therapy advocates surgery/lithotripsy in most of the cases. However
chenodeoxycholic acid (10-15 mg./Kg./day) or Ursodeoxycholic acid 8-10 mg./Kg./day) may be
given to dissolve gall stone in 50-70% of the cases within 2 years. Recurrence can occur on
discontinuation of the therapy.
The patient of cholelithiasis-cholecystitis may present as acute cholecystitis or chronic
cholecystitis. The patients to be taken for Ayurvedic research may be of chronic cholecystitis.
II. OBJECTIVE
No significant contribution has been made to the treatment of Pittashmari (Gall Stone) in
Ayurvedic science, yet there are different claims. It has been considered worthwhile to find out the
effect of some claimed and popular Ayurvedic medicines, practiced to remove stone. The present
study is launched with a view to:
Study the disease incidence, Clinical picture and disease pattern of Pittashmari (Gall
Stones).
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See the effect of Vijaura Nimbu swaras + saindhava + Kalami Shora + Nausadara + Ela
combination of radiologically/ultrasonographically proved cases of Pittashmari (Gall Stone).
See the effect of Pathar Chatti swaras + Ikshuraka Kshara + Kali Mirch in the diagnosed
cases of Pittashmari (Gall Stone)
To study comparatively the effect of treatments in group (ii) and (iii).
III. CENTRE :
CCRAS identified Centres
IV. SAMPLE SIZE & METHODS
No of Groups: 2
No of patients in each group: 20
(Patients to be randomly allocated to different treatment groups)
Treatment:
Group I: Vijaura Nibu swarasa — 750 ml.
Saindhava — 20 gm.
Kalami Shora — 10 gm.
Nausadara — 10 gm.
Ela — 10 gm.
Mixed and filtered — 20 ml. thrice a day for 30 days
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V. CRITERIA OF INCLUSION
1) Age > 10 years < 60 years
2) Sex-either-sex
3) Chronicity: Disease note older more than 5-7 years.
4) Murphy’s sign: Pain/Catch in deep breath when the fingers are pressed below right coastal
cartilage.
5) Patients of chronic cholecystitis/silent gall stones
6) Obese/non-obese
7) High lipid/normal lipid
8) Clinical feature of chronic cholecystitis with positive murphy’s sign.
9) Gall stone observed by definite investigative procedures e.g.
- Plain X-ray abdomen
- Oral cholecystogram
- Ultrasonography
- Endoscopic retrograde cholangiography and percutaneous hepatic cholangiography
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11. Patients on steroids
12. Patient with polyarteritis
VII. CRITERIA FOR WITHDRAWAL:
1. Discontinuation of treatment during the trial
2. Development of any complications
3. Aggravation of the disease symptoms
4. Any side effect of the drug
VIII. ROUTINE EXAMINATION AND ASSESSMENT
The full details of history and physical examination of the patients will be recorded as per
the proforma (Forms I & IA). Clinical and physiological assessment will be done before drug
administration and after every two weeks. The laboratory investigations- urine routine and
microscopic, stool examination, blood sugar fasting & pp, lipid profile, x-rays: plain x-ray
abdomen, oral cholecystogram, ultrasonography,endoscopic retrograde, cholangiography will be
recorded before drug administration, at the end of treatment (Form-III)
IX. CRITERIA FOR ASSESSMENT
Assessment will be done as per proforma after 3 months of regular treatment as per the
proforma. However, the patients are to be reviewed after every two weeks.
1. Good Response: Complete disappearance of signs and symptoms with no complications
and considerable regression in the size of the stone/complete disappearance of the stone.
2. Fair response: 50% and above relief in symptomatology with some regression in the size
of the stone.
3. Poor response: 25% and above relief in symptomatology with no change in the size of the
stone.
X. STATISTICAL ANALYSIS:
Data on clinical symptoms and objective tests before and after the treatment will be
tabulated and analyzed using appropriate statistical tools. However, the data of each case will have
to be communicated on completion of trial therapy to the Statistical Officer of CCRAS through e-
mail.
XI. TRIAL MONITORING AND DATA ANALYSES
The progress of the trial will be monitored by CCRAS HQrs. New Delhi. Data analysis
will be undertaken at the Monitoring Unit CCRAS HQrs. New Delhi
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XII. ETHICAL REVIEW
Each Institutional Ethical Committee (IEC) of participating centers should give clearance
certificate before the project is initiated. Patient’s information sheet and informed consent form
should be submitted along with project proposal for approval by IEC. Both should be maintained
in duplicate with one copy given to the patient at the time of entry to the trial.
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF VIJAURA NIBU SWARAS ALONGWITH
SAINDHAVA, KALAMI SHORA AND NAUSADARA IN ONE GROUP VIS-A-VIS
PATHAR CHATTI SWARAS ALONGWITH IKSHUARAKA AND KALI MIRCH
IN THE MANAGEMENT OF PITTASHMARI (GALL STONE)
WRITTEN INFORMED CONSENT FORM
CERTIFICATE BY INVESTIGATOR
I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature of the subject: ______________
Name: ____________________________
CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending physician, the purpose of the
clinical trial and the nature of drug treatment and follow-up, including the laboratory investigations
to be performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so.
I, exercising my free power of choice, hereby give my consent to be included as
a subject in the clinical trial on evaluation of vijaura nibu swaras alongwith saindhava,
kalami shora and nausadara in one group vis-a-vis pathar chatti swaras alongwith
ikshuaraka and kali mirch in the management of pittashmari (gall stone).
Date:___________ Name of the Subject:_____________________________
Relationship ___________________________________
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF VIJAURA NIBU SWARAS ALONGWITH
SAINDHAVA, KALAMI SHORA AND NAUSADARA IN ONE GROUP VIS-A-VIS
PATHAR CHATTI SWARAS ALONGWITH IKSHUARAKA AND KALI MIRCH
IN THE MANAGEMENT OF PITTASHMARI (GALL STONE)
PATIENT INFORMATION SHEET
118
What happens at the end of the study?
The trial treatment will be stopped at the end of 30 days. You will be put back on an
appropriate treatment available in the market.
What are the alternatives?
Your doctor will be pleased to explain to you the available alternative treatment.
When you can leave the study?
Your participation in the study is entirely voluntary. You can choose to leave the study at
any time. Your decision to leave the study will not affect your medical care or relationship with
your doctor.
Your doctor may decided that you should not continue in the study if, a) your blood sugar
becomes very high or very low, b) you start on insulin or other medication that affect blood sugar,
c) you take part in any other trial.
What is the cost of the study?
All medication and tests to be done during the study will be free of charge.
If you do not want to participate, you are free to do so. It will not affect your medical
care or relationship with your doctor in any way.
What happens now if you decided to take part?
You will asked to sign a consent form saying that you have been given information about
the study and you voluntarily agree to take part.
It is important to follow all instruction given by your doctor or doctor’s assistant carefully.
If you are found eligible, you would be put on trial treatment for 30 days.
At each visit, you will be supplied with sufficient quantities of drugs to last until
your next visit. If any adverse reactions like skin allergy, nausea, vomiting and
palpitation/tremor etc., noticed during the treatment period, this should be noticed to the
Principle Investigator.
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF VIJAURA NIBU SWARAS ALONGWITH
SAINDHAVA, KALAMI SHORA AND NAUSADARA IN ONE GROUP VIS-A-VIS
PATHAR CHATTI SWARAS ALONGWITH IKSHUARAKA AND KALI MIRCH
IN THE MANAGEMENT OF PITTASHMARI (GALL STONE).
CASE REPORT FORM I – SCREENING
BEFORE TREATMENT
(Enter a in the appropriate box)
1. Centre: ………………..……….
6. Address ……………………………………..………………………………………
7. Obese/Non-obese
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CRITERIA FOR EXCLUSION Yes (1) No (0)
9. Acute cholecystitis
13. Pregnancy
14. Colic/Typhoid/Jaundice
16. Empyema/Septicaemia/Shock
If Sl. No. 1-8 is ‘Yes’ and Sl. No. 9-18 are ‘No’
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF VIJAURA NIBU SWARAS ALONGWITH
SAINDHAVA, KALAMI SHORA AND NAUSADARA IN ONE GROUP VIS-A-VIS
PATHAR CHATTI SWARAS ALONGWITH IKSHUARAKA AND KALI MIRCH
IN THE MANAGEMENT OF PITTASHMARI (GALL STONE)
CASE REPORT FORM II – HISTORY
1. Centre: ………………..……….
4. Address : ..............................................................................................................................
7. Educational status: Illiterate (1) Read and Write(2) Primary School (3)
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10. Religion Hindu (1) Muslim (2) Christian (3)
16. Nausea
17. Fever
18. Jaundice
If yes, specify…………………………………………………………….........……………
H/o Operation
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H/o Treatment-hepatotoxic drugs/oestrogens/steroids
24. Carcinoma
26. Polyarteritis
If yes specify……………………………………......….…………………………………….
PERSONAL HISTORY
If yes, specify………………………………………………………………………............
Sannipataj (7)
Sama (7)
PHYSICAL EXAMINATION
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36. Gait Normal (1) Abnormal (2)
40. Pulse
Non-tender
Palpable
Tender
Palpable
Tender
Palpable
46. C.N.S
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47. Digestive system
Pidika
Mukhapak
Vidradhi (Abcess)
Kamla
Atibadha Purisha
Atidhrava Purisha
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Scantly stool
Painful defecation
LAB INVESTIGATION
Microscopic
1. Urine
Routine
2. Blood
(i) Hb%
(ii) TLC
(iii) DLC
(iv) ESR
BIOCHEMICAL
Microscopic
(1). Urine
Routine
(iii) HDL
(iv) LDL
(v) VLDL
(vi) S. CHOLESTEROL
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X-RAY
(iii) Ultrasonography
Provisional Diagnosis
Final Diagnosis
Medical Management
Dose
Vehicle
Diet
Summary of findings
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF VIJAURA NIBU SWARAS ALONGWITH
SAINDHAVA, KALAMI SHORA AND NAUSADARA IN ONE GROUP VIS-A-VIS
PATHAR CHATTI SWARAS ALONGWITH IKSHUARAKA AND KALI MIRCH
IN THE MANAGEMENT OF PITTASHMARI (GALL STONE)
CASE REPORT FORM III– CLINICAL ASSESSMENT
1. Centre: ………………..……….
4. Address : ..............................................................................................................................
CLINICAL PARAMETERS
Pain abdomen
Fullness/belching/wretching
Nausea/Vomiting
Fever
Jaundice
Hyprochondriac tenderness
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF VIJAURA NIBU SWARAS ALONGWITH
SAINDHAVA, KALAMI SHORA AND NAUSADARA IN ONE GROUP VIS-A-VIS
PATHAR CHATTI SWARAS ALONGWITH IKSHUARAKA AND KALI MIRCH
IN THE MANAGEMENT OF PITTASHMARI (GALL STONE)
CASE REPORT FORM IV – LABORATORY INVESTIGATION
Post Prandial
2. E.S.R.
3. Lipid Profile
- HDL
- LDL
- VLDL
- S. Cholesterol
- Serum Triglycerides
- Ultrasonography
- Oral Cholecystogram
130
CLINICAL STUDY ON SERO CONVERSION OF HBs
Ag (CARRIERS) WITH CODED AYURVEDIC
FORMULATION ‘AYUSH-LIV’
131
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132
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL STUDY ON SERO CONVERSION OF HBs Ag (CARRIERS) WITH
CODED AYURVEDIC FORMULATION ‘AYUSH-LIV’
I. BACKGROUND
Hepatitis B1 is one of the major diseases of mankind and is a serious global public health
problem. It is preventable with safe and effective vaccines that have been available since 1982.
Hepatitis B Virus (HBV) is the most versatile of the hepatotropic Viruses. HBV can produce (1)
Acute hepatitis (2) Chronic non progressive hepatitis (3) Progressive chronic disease ending in
cirrhosis (4) Fulminant hepatitis with massive liver necrosis and (5) an a symptomatic carrier with
or without progressive disease. It has been documented by the WHO that world wide, there are
over 400 million hepatitis ‘B’ carriers, of which 42 million are in India alone. These carriers are at
200 times greater risk of developing serious liver complication including cirrhosis and liver cancer.
An HBV carrier is one who had hepatitis B in his blood for more than six months. A
carrier usually has no signs or symptoms of HBV but remains infected with the virus for years or
for a life time and is capable of passing the disease on to others. Sometimes HBV carriers will
spontaneously clear the infection from their bodies, but most will not. Any one who has not cleared
the virus after six months and has elevated liver enzymes is considered to have chronic hepatitis.
This means, the virus is infecting living liver cells and damaging them. Scar tissue called cirrhosis
replaces the damaged cells. The build up of Cirrhosis causes the liver to become hard and bumpy
and distorts the blood flow through this vital organ.
Characteristics of a HBs Ag Carrier state:
Carriers usually have no history of acute hepatitis and no clinical features of liver disease.
All of them have HBs Ag in blood. Some have HBe Ag and Anti HBe. Most of them have
normal liver function tests. Prognosis is uncertain. Virus can be carried for years. Some develop
chronic hepatitis and others are at increased risk of developing cirrhosis and hepato cellular
carcinoma.
Transmit ion of infection:
Hepatitis B Virus is transmitted by contact with blood or body fluids of an infected person
in the same way as human immuno-deficiency Virus (HIV). However HBV is 50 to 100 times
more infectious than HIV.
References
1. Harrison’s Principle of Internal Medicine 15th Edition
133
The Hepatitis B Virus (HBV) gets transmitted through
1. Prenatal (From mother to baby at the birth)
2. Child to child transmission
3. Unsafe injections and transfusions
4. Sexual contact
Hepatitis B virus is not spread by contaminated food or water and cannot be spread
casually in the work place.
Viral markers:
Chronic HBV infection is marked by the presence of HBs Ag) in the blood. At times the
Hbe Ag and Anti Hbe is also present. Presence of Hbe Ag indicates active viral replication.
Presence of Anti Hbe implies that replication is occurring at much lower level or that viral DNA
has become integrated into host Hepatocyte DNA.
PCR: Polymerase chain reaction can show HBV DNA in the blood, implying that viral
replication is occurring. This is essentially needed for formulating the treatment protocol..
Based on serological markers, hepatitis B carriers are classified into two categories super
carriers and simple carriers.
Super carrier: Those who have HBe Ag in their blood and are in the early stage of the
carrier state are very highly infectious. Very minute amount of serum or blood from such carriers
can transmit the infection. They have high titres of HBs Ag and DNA Polymerase in their blood.
Simple carrier: Very common type with no HBe Ag and a low level of HBs Ag in the
blood. HBV DNA Polymerase is negative. Simple carrier transmits the infection only when large
volumes of blood or serum are transferred as in blood transfusion. Simple carrier represents the
later stage of the carrier state.
Interferon is one of the drugs of choice for use in Chronic hepatitis B infection. Clinical
utility of interferon is limited by substantial adverse effects such as Flu like symptoms. Fatigue,
visual disturbances, Neuro toxicity, Neutropenia , Hypo tension etc.
As per Ayurvedic texts several plant drugs are known for its hepato protective, anti
hepatotoxic and anti-viral properties. A coded drug Ayush-Liv with four herbal ingredients having
above mentioned properties is selected to explore the possibilities of these drugs in combination in
the clearance of Hepatitis-B Virus.
II. OBJECTIVES
1. To study the efficacy of the Ayush-Liv formulation to get the viral marker, Hbs Ag sero
negative.
134
2. To study the efficacy of Ayush-Liv formulation in maintaining the liver parameters within
normal limits.
III. CENTERS
CCRAS identified Centers
IV. SAMPLE SIZE & METHODS
Sample size: 30 cases
Type of Study: Open trial
Trial Drug /Dosage /Duration
Group I - Allopathic drug + placebo (60 days)
Group II - Allopathic drug + AYUSH-LIV (two Caps, 550mg each twice
a day after food with water).
Type of study : Placebo controlled study
Period of study: Two months for each case and Post study surveillance screening
for one month. Total duration will be two years to complete the
study.
Follow Up : One follow up will be carried out after three months of completion
of the treatment.
V. CRITERIA FOR INCLUSION
1. Age between 18-60
2. HBs Ag positive in blood (Eliza test)
3. Normal liver function test [Serum bilirubin total<1 mg, Serum bilirubin direct <0.2mg,
Serum bilirubin indirect) <.0.8mg, SGOT<=40, SGPT<=40, SAP<13 KA Unit
4. Total protin <5.6>8.5 gm,
5. Albumin >4<6.7 gm
6. Total Globulin >1.2<2.9 gm
VI. CRITERIA FOR EXCLUSION
1. Age below 18 and above 60 years.
2. Viral markers positive for Anti HBc (IgG,IgM) Anti HBs, HBeAg, anti HBe
3. History of Jaundice during last two years
135
4. Abnormal Hematological cell count
5. Drug addicts
6. Alcohol addicts
7. Serum bilirubin total>1 mg, Serum bilirubin direct>0.2mg, Serum bilirubin
Indirect >.0.8 mg., SGOT>40 , SGPT>40, SAP>13 KA Unit
8. Total protein >5.6<8.5 gm,
9. Albumin <4>6.7 gm
10. Total Globulin <1.2>2.9 gm
VII. CRITERIA FOR WITHDRAWAL
i) If any increase in LFT parameters is observed in subsequent investigations the case will be
withdrawn.
ii) A case will be withdrawn from the study if there is development of any major ailments or
clinical symptoms of Jaundice.
iii) Patients failure to report for follow up or irregular medication (discontinuation for seven
days or above)
Patients withdrawn from the study will be managed by the Investigators.
VIII. ROUTINE EXMINATION AND ASSESSMENT
The full details of history and physical examination of patients will be recorded as per the
Proforma (Form I &IA). Clinical assessment will be done before drug administration, every
fortnightly till the completion of the treatment. The laboratory investigations will be recorded before
drug administration, every month till the end of treatment and at the end of follow-up. [Form III].
Eliza Test for HBs Ag : Every month and at the end of follow-up
Anti HBc, anti HBs : At the time of inclusion
Hbe Ag and anti HBe
LFT : Before treatment and every month till the end of
treatment and at the end of follow-up.
IX. CRITERIA FOR ASSESSMENT
If HBs Ag becomes sero negative during treatment or after completion of the treatment it
will be considered a successful outcome of the treatment. 40% difference in the success rate
between the placebo ant the treatment group will be considered significant outcome.
136
X. STATISTICAL ANALYSIS
Data on clinical symptoms and objective tests before and after the treatment will be
tabulated and analyzed using appropriate statistical tools. However, the data of each case will have
to be communicated on completion of trial therapy to the Statistical Officer of CCRAS through e-
mail.
XI. TRIAL MONITORING AND DATA ANALYSIS
CCRAS, Hqrs, New Delhi will undertake the monitoring of progress of the trial and data
analysis.
XII. ETHICAL REVIEW
A. Ethical Committee (IEC): The proposal will be placed before Ethical Committee
(IEC) of trial center for getting clearance certificate before the project is initiated. Patient’s
information sheet and informed consent form will be submitted along with project proposal for
approval by EC. Both will be maintained in duplicate with one copy given to the patient at the
time of entry to the trial.
B. Data and safety monitoring board: A Data and safety monitoring board
(DSMB) at Hqrs. will carefully monitor the data and side effects during the period of study and
put in a place where by prompt reporting of adverse events occur. The data will be reviewed as
every 20 participants entered the study and administered the trial drugs. The research team will
report immediately to the PI and Data Monitoring Board if, any life threatening conditions whether
they are perceived to be study related or not. The Board decides whether the adverse effects
warrant discontinuation of the study protocol. Protocols will be written and approved for the
treatment of study related adverse events.
XIII. TRAVELING EXPENSES FOR RESEARCH SUBJECTS
A consolidated amount of Rs.……. /- per visit will be paid to subject.
XIV. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
Short-term two-day training will be provided to the Investigators and Laboratory
personnel involved in the multi-centric trial at CCRAS Hqrs. and Central Research Institute (Ay.),
New Delhi. The investigators and technicians will be detailed about the clinical trial conduct and
laboratory procedures in order to maintain the uniformity.
XV. LABORATORY INVESTIGATIONS
The Laboratory Investigations (Pathological/Biochemical, etc.), which are not available at
research Institutes should be conducted at identified reputed labs /Government Institutes under
intimation to this Council following codal formalities.
137
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL STUDY ON SERO CONVERSION OF HBs Ag (CARRIERS) WITH
CODED AYURVEDIC FORMULATION ‘AYUSH-LIV’
WRITTEN INFORMED CONSENT FORM
CERTIFICATE BY INVESTIGATOR
I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature of the subject: ______________
Name: ____________________________
CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending physician, the purpose of the
clinical trial and the nature of drug treatment and follow-up, including the laboratory investigations
to be performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so.
I, exercising my free power of choice, hereby give my consent to be included as a subject
in the clinical trial on healthy carriers of hepatitis ‘B’ with herbal compounds.
Relationship ___________________________________
138
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
PROTOCOL FOR CLINICAL STUDY ON SERO CONVERSION OF HBs Ag
(CARRIERS) WITH CODED AYURVEDIC FORMULATION AYUSH-LIV
PATIENT INFORMATION SHEET
139
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
PROTOCOL FOR CLINICAL STUDY ON SERO CONVERSION OF HBs Ag
(CARRIERS) WITH CODED AYURVEDIC FORMULATION AYUSH-LIV
CASE REPORT FORM I - SCREENING
BEFORE TREATMENT
(Enter a in the appropriate box)
1. Centre: ………………..……….
6. Address ……………………………………..………………………………………
6. SGOT<=40 mg
7. SGPT<=40 mg
8. SAP<13 KA Unit
140
CRITERIA FOR EXCLUSION Yes (1) No (0)
24. SGOT>40 mg
25. SGPT>40 mg
141
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
PROTOCOL FOR CLINICAL STUDY ON SERO CONVERSION OF HBs Ag
(CARRIERS) WITH CODED AYURVEDIC FORMULATION AYUSH-LIV
CASE REPORT FORM II – HISTORY
(Enter a in the appropriate box)
1. Centre: ………………..……….
7. Address ……………………………………..……………..........…………………………
8. Educational status: Illiterate (1) Read and Write(2) Primary School (3)
10. Income
142
History of Past Illness Yes (1) No (0)
11. Jaundice
Any injection
14. Intramuscular
15. Intravenous
Personal History
Addiction
143
21. Any other, specify: ___________________________________________________
Physical Examination
28. CVS
If abnormal details___________________________________________
30. CNS
33. If any
If Present, specify____________________________________________
144
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
PROTOCOL FOR CLINICAL STUDY ON HEALTHY CARRIERS OF
HEPATITIS ‘B’ WITH CODED AYURVEDIC FORMULATION AYUSH-LIV
(0th, 1st & 2nd Month)
CASE REPORT FORM III – CLINICAL ASSESSMENT
1. Centre: ………………..……….
7. Date of Assessment:
8. Period of Assessment: Initial (0) 1st Month (1) 2nd Month (2)
9. Fever
10. Anorexia
11. Nausea
12. Vomiting
16. Malaise
145
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
PROTOCOL FOR CLINICAL STUDY ON SERO CONVERSION OF HBs Ag
(CARRIERS) WITH CODECD AYURVEDIC FORMULATION AYUSH-LIV
(0, First & Second Month)
CASE REPORT FORM IV– LABORATORY INVESTIGATIONS
1. Centre: ………………..……….
7. Date of Assessment:
9. Sugar: ___________________
Blood
146
17. Blood Sugar – PP (mg. /dl): ________________
Physiological Parameters
147
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148
JOINT DISORDERS
SECTION - III
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150
COMPARATIVE CLINICAL EVALUATION OF
PHANCHKARMA VERSUS PHYSIOTHERAPY IN
PATIENTS OF SANDHIVATA (OSTEOARTHRITIS) -
KNEE JOINT
151
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152
COMPARATIVE CLINICAL EVALUATION OF PHANCHKARMA VERSUS
PHYSIOTHERAPY IN PATIENTS OF SANDHIVATA (OSTEOARTHRITIS)-
KNEE JOINT
I. BACKGROUND
Panchakarma is a textual classical and authentic treatment procedure of Ayurveda. Our
ancient sages and scholars like Charaka and Vagbhatta have attributed a lot of potential benefits
to Panchkarma practices. The aim of the study is to see the effect of Panchakarma in group I
patients of Sandhivata (Osteoarthritis) and to compare the results with known physiotherapy
treatment in the patients of group II. This Physiotherapy treatment is usually referred to by doctors
of various Systems of Medicines1.
II. OBJECTIVE
Comparative clinical evaluation of Panchkarma versus Physiotherapy in patients of
Sandhivata (Osteoarthritis) - knee joint, with selected clinical parameters.
III. CENTRES
CCRAS identified centers
IV. SAMPLE SIZE AND METHODS
Type of study : Open trial
Level of study : OPD/IPD
Number of Groups : Two Groups
Sample Size : 30 (15 patients in each group)
References
1. Charaka Samhita with Ayurveda Dipika commentary of Chakrapanidatta, Chikitsa Sthana, Chapter – 28,
Chaukhambha Sanskrit Sansthan, 5th edition, Varanasi, 2001
2. Clare Jinks, Kelvin Jordan Measuring the population impact of knee pain and disability with the
Western Ontario and McMaster Universities Osteoarthritis Index. Pain 2002: 100, 55-64.
3. Gail D Dyele, Stephen C Allison, Robert L Matekel. Physical Therapy treatment effectiveness for
osteoarthritis of the knee: A randomized comparison of supervised clinical exercise and manual therapy
procedures versus a home exercise program. Physical Therapy 2005: 85, 12, 1301-1317.
4. Effects of repetitive shortwave diathermy for reducing synovitis in patients with knee osteoarthritis: An
ultrasonographic study Physical therapy 2006: 86, 2, 236-244.
153
Drug/Dosage/Duration:
Group-I Panchkarma Group:
• Local application of Pancaguna Taila 10-15 ml each joint, thrice a day
• Nadi Sweda with Dashmoola Kwatha for 15 minutes, followed by rest for 15
minutes.
The above mentioned Panchkarma treatment will be given for 4 weeks in the hospital
followed by 2 weeks Pancaguna Taila application at home.
Group-II Physiotherapy Group:
• Exercise Protocol for 4 weeks continuously in the hospital which will consist of
Manual Therapy, Stretching, Strengthening, and Range of Motion Exercises, followed
by exercises at home for another 2 weeks.
• Associated with above treatment, shortwave diathermy (a type of thermal therapy) for
initial 2 weeks (6 days/ week).
Duration of treatment : 4 weeks in both the groups
Follow up period : After 2 wks
V. CRITERIA FOR INCLUSION
1. Age between 40 years to 70 years.
2. Sex-Either sex
3. Patients with Primary Osteoarthritis – knee joints (single or both knees)
4. Kellgren Lawrence (Radiological scale) of e” 2.
Note: Patients taking Ayurvedic/Allopathic NSAIDs orally may be included in the study but the
treatment may be considered as basal treatment and it should not be altered during the trial.
VI. CRITERIA FOR EXCLUSION
1. Age less than 40 years or more than 70 years.
2. Patients with skin allergies/skin diseases
3. Patients with Pott’s spine/infections/other systemic diseases
4. Patients with systemic conditions such as Gouty Arthritis, Rheumatoid Arthritis Psoriatic
Arthritis, SLE.
5. Patients with Diabetes/Hypertension
154
6. Bed ridden patients
7. Patients using local Anti-inflammatory medicine other than the research drugs.
8. Patients taking active Allopathic/Homeopathic treatment.
9. Low backache with or without radiation to legs.
10. Patients with metallic implants.
11. Subjects having any deformity of knee, hip or back.
12. History of bony or soft tissue injury to knee joint.
VII. CRITERIA FOR WITHDRAWAL
During the course of treatment, if any serious condition or any serious adverse events
occurs or pain/stiffness/swelling increases, or if subject himself/herself wants to withdraw from the
study, such subjects may be withdrawn from the study.
VIII. ROUTINE EXAMINATION/ASSESSMENT:-
Inclusion into study - 0 day
1st assessment - 14th day
2nd assessment - 28th day
3rd assessment - 42nd day
Assessment Chart – annexed in case record form.
(Based on visual analogue scale).
Radiography-I
To diagnose the patients (at or before day 0) at the time of inclusion.
Radiography-II
To be compared with Radiography-I at the time of final assessment i.e. 45th day.
However much radiographical changes are not expected.
Result expectations:
30 to 35% improvement is expected in treatment groups.
However 10 to 20% improvement may also be there in placebo group.
IX. STATISTICAL ANALYSIS
Clinical symptoms and laboratory parameters will be analyzed using appropriate statistical
methods.
155
X. TRIAL MONITORING
Monitoring unit of CCRAS Headquarters, New Delhi will monitor the progress of the trial.
Data analysis will be undertaken by the Monitoring unit at CCRAS headquarter.
XI. ETHICAL REVIEW
A. Institutional Ethical Committee (IEC): The proposal will be placed before Ethical
Committee (IEC) of trial center for getting clearance certificate before the project is initiated.
Patient’s information sheet and informed consent form will be submitted along with project
proposal for approval by EC. Both will be maintained in duplicate with one copy given to the
patient at the time of entry to the trial.
B. Data and Safety Monitoring Board (DSMB): A Data and safety monitoring board
(DSMB) at Hqrs. will carefully monitor the data and side effects during the period of study and
put in a place where by prompt reporting of adverse events occur. The data will be reviewed as
every 20 participants entered the study and administered the trial drugs. The research team will
report immediately to the PI and Data Monitoring Board if, any life threatening conditions whether
they are perceived to be study related or not. The Board decides whether the adverse effects
warrant discontinuation of the study protocol. Protocols will be written and approved for the
treatment of study related adverse events.
XII. TRAVELING EXPENSES FOR RESEARCH SUBJECTS
A consolidated amount of Rs……. /- per visit.
XIII. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
Short-term two-day training will be provided to the Investigators and Laboratory
personnel involved in the multi-centric trial at CCRAS Hqrs. The investigators and technicians will
be detailed about the clinical trial conduct and laboratory procedures in order to maintain the
uniformity.
XIV. LABORATORY INVESTIGATIONS
The Laboratory Investigations (Pathological/Biochemical, etc.), which are not available at
research Institutes should be conducted at identified reputed labs /Government Institutes under
intimation to this Council following codal formalities.
Counseling about life style:-
During the research period, the patient should maintain uniform life style or basal life style
(what he was adopting in general). Over exercise, over strain, riding bicycle, going upstairs or
sitting in squatting positions may seriously alter the results.
156
To Check the drug compliance
The packing of the oil should be proper with no mark over the bottle so as to avoid bias.
At each visit, patient must bring his/her medicine bottle and submit it to the researcher so that the
consumption of medicine may be checked.
Expected medicine requirement for 42 days
Oil requirement for 6 weeks (42 days):
One application on one joint = 10-15 ml x 3 times a day
= 30-45 ml.
In case of two joint involved 60 - 90ml per day.
Let us take average of 50ml per day per patient.
Thus total oil requirement for 42 days for 15 patients will be = 50 x 42 x 15
= 32 liters
Medicine requirement for 4 weeks (28 days):
Dashmoola required per day per patient = 50 gms
Requirement for 28 days for 1 patient = 50 x 28
= 1400 gms
Thus total medicine required for 28 days for 15 patients = 50 x 28 x 15
= 21kg
PHYSIOTHERAPY TREATMENT
1. Patient Exercise Program: Strengthening Exercises
157
Standing Perform 3 X per week Hold each contraction for 3 s.
terminal knee Patient stands with a resistive band or a Repeat 10X
extension cuff from a weighted pulley mechanism Increase resistance as
behind a slightly flexed knee. Patient tolerated
contracts the gluteal and quadriceps
femoris muscles to fully straighten the hip
and knee
158
2. Patient Exercise Program: Stretching Exercises
159
3. Patient Exercise Program: Range of Motion Exercises
Knee in mid- Performed once daily Two 30-s bouts with 3-s hold
flexion to full- Patient is positioned supine or supine at end range.
flexion supported Clinical observation: pain with
on elbows Knee is brought to full flexion end-range knee flexion may
with assistance of the upper extremities be due to degenerative
or a strap A gentle challenge to end- meniscal tears
range flexion is sustained. Over-pressure to end range
should be applied with
caution.
160
4. Common Knee Impairments Addressed by Manual Therapy
Loss of knee Manual mobilization through ROM and Mobilization grades of III-
flexion knee flexion at end range and IV- to III+ and IV+ 2–6
Knee flexion bouts of 30 s per manual
Knee flexion plus medial (internal) technique
rotation Clinical observation: pain with
end-range knee flexion may
be due to degenerative
meniscal tears; end-range
techniques should be
utilizedwith caution.
161
Hamstrings Clinical observation: the
Gastrocnemius lumbar spine should be
Adductors manually stabilized and
Iliopsoas protected during all extremity
Tensor fasciae latae and the iliotibial stretches, particularly hip
band flexor stretches; many of
these patients also will have
arthritic changes in the spine,
and symptoms can be
increased without care in
positioning.
162
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
COMPARATIVE CLINICAL EVALUATION OF PHANCHKARMA VERSUS
PHYSIOTHERAPY IN PATIENTS OF SANDHIVATA (OSTEOARTHRITIS)-
KNEE JOINT
INFORMED CONSENT FORM
CERTIFICATE BY INVESTIGATOR
I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature of the subject: ______________
Name: ____________________________
CONSENT BY SUBJECT
The attending physician, the purpose of the clinical trial and the nature of drug treatment
and follow-up have informed me to my satisfaction, including the laboratory investigations to be
performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so. I am willing to undergo any risk for inclusion in
this study.
I, exercising my free power of choice, hereby give my consent to be included as a subject
in the “Comparative clinical evaluation of phanchkarma versus physiotherapy in patients of
sandhivata (osteoarthritis)-knee joint”.
Relationship ___________________________________
163
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
COMPARATIVE CLINICAL EVALUATION OF PHANCHKARMA VERSUS
PHYSIOTHERAPY IN PATIENTS OF SANDHIVATA (OSTEOARTHRITIS)-
KNEE JOINT
PATIENT INFORMATION SHEET
164
Any risk to the subject associated with the study
Though the side effects are not very common, however in rare cases patient might develop
allergy with the oil. At times local irritation/ skin burn may happen during heat application.
Maintenance of the confidentiality of records
The records of the study will be kept confidential to protect volunteer’s privacy.
Compensation of subjects for disability or death resulting from injury
Not applicable
Freedom of individual to participate and to withdraw from research at anytime
without penalty or loss of benefits to which the subject would otherwise be entitled
Subjects will be free to withdraw from the study at any stage without assigning any reason,
without penalty or loss of benefits to which he/she would otherwise be entitled.
165
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
COMPARATIVE CLINICAL EVALUATION OF PHANCHKARMA VERSUS
PHYSIOTHERAPY IN PATIENTS OF SANDHIVATA (OSTEOARTHRITIS)-
KNEE JOINT
CASE REPORT FORM – 1 SCREENING
Before Treatment
(Please tick wherever is applicable)
1. Centre: ………………..……….
6. Address ……………………………………..………………………………………
2. Sex-Either sex
166
11. Patients with systemic conditions such as Gouty
Arthritis, Rheumatoid Arthritis Psoriatic Arthritis, SLE.
167
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
COMPARATIVE CLINICAL EVALUATION OF PHANCHKARMA VERSUS
PHYSIOTHERAPY IN PATIENTS OF SANDHIVATA (OSTEOARTHRITIS)-
KNEE JOINT
CASE REPORT FORM – II HISTORY
Before Treatment
(Please tick wherever is applicable)
1. Centre: ………………..……….
7. Address ……………………………………..……………..........…………………………
9. Educational status: Illiterate (1) Read and Write(2) Primary School (3)
168
12. Total family members:
18. History of past illness, having relation with present illness : Yes (1) No (0)
If yes, Specify______________________________________________________
Family History:
Fish-veg (4)
Sannipataj (7)
Sama (7)
169
Chief complaints with duration:
24. PAIN
Duration
25. STIFFNESS
Duration
26. SWELLING
Duration
Duration
Duration
Climate
Season
170
Day/night
Rest/movement
Walking/exertion
171
Samprapti (pathogenesis) of the disease according to Ayurvedic concept:
Anubandhya dosha
Anubandh dosha
Avaraka dosha
Ksheen dosha
172
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
COMPARATIVE CLINICAL EVALUATION OF PHANCHKARMA VERSUS
PHYSIOTHERAPY IN PATIENTS OF SANDHIVATA (OSTEOARTHRITIS)-
KNEE JOINT
CASE REPORT FORM – III LABORATORY INVESTIGATION
(Please tick wherever is applicable)
1. Centre: ………………..……….
9. Date of Assessment :
INVESTIGATIONS PROFORMA
• TLC: _________________________
• DLC: _________________________
• ESR: _________________________
• Hb %: _________________________
• RA Factor: _________________________
173
• Blood Urea: _________________________
• Others: _________________________
12. Radiology
• Effusion: _________________________
• Osteoporosis: _________________________
• Deformity: _________________________
• Ankylosis: _________________________
174
ASSESSMENT OF TRIAL
Grade 0 = No Symptoms
Grade 1 = Mild Symptoms
Grade 2 = Symptoms Sufficient to Cause Distress/Difficulty in performing routine work
Grade 3 = Symptoms very severe/ patient unable to perform his routine work.
0 1 2 3 0 1 2 3
Pain
Tenderness
Swelling
Stiffness
Fatigue
Restricted Movement
Deformity
Walking Time
(Seconds)
Pressing Power
(mm/Hg)
ESR(mm/Hr)
Hb (Gm %)
175
WOMAC OSTEROARTHRITIS INDEX
SECTION A
PAIN
1 2 3 4 5 6 7 8 9 10
1 2 3 4 5 6 7 8 9 10
1 2 3 4 5 6 7 8 9 10
1 2 3 4 5 6 7 8 9 10
5. While standing?
1 2 3 4 5 6 7 8 9 10
176
SECTION B
STIFFNESS
6. How severe has your stiffness been after you first woke up in the morning?
1 2 3 4 5 6 7 8 9 10
7. How severe has your stiffness been after sitting or lying down or while resting leter in the
day?
1 2 3 4 5 6 7 8 9 10
177
SECTION C
PHYSICAL FUNCTION
1 2 3 4 5 6 7 8 9 10
1 2 3 4 5 6 7 8 9 10
1 2 3 4 5 6 7 8 9 10
1 2 3 4 5 6 7 8 9 10
1 2 3 4 5 6 7 8 9 10
178
13. When walking on a flat surface?
1 2 3 4 5 6 7 8 9 10
1 2 3 4 5 6 7 8 9 10
1 2 3 4 5 6 7 8 9 10
1 2 3 4 5 6 7 8 9 10
1 2 3 4 5 6 7 8 9 10
1 2 3 4 5 6 7 8 9 10
179
APPENDIX
180
RECEIPT
Received an amount of Rs 500/ (Five hundred only) from the institute as traveling expenses
for traveling to and fro the Institute for 4 weeks so as to participate in the above mentioned
research,
181
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182
CLINICAL VALIDATION OF GUGGULU, SHUNTI &
GUDUCHI IN RHEUMATOID ARTHRITIS
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL VALIDATION OF GUGGULU, SHUNTI & GUDUCHI IN
RHEUMATOID ARTHRITIS
I. BACKGROUND
Rheumatoid arthritis1 is a chronic multisystem disease characterized by persistent
inflammatory synovitis, usually, involving peripheral joints in a symmetric distribution. The potential
of synovial inflammation to cause cartilage destruction and bone erosions & subsequent changes in
joint integrity is the hallmark of the disease.
Exact etiology is unknown. Although recent work has focused on the possible role of
super antigens produced by a number of microorganism including staphylococci, streptococci and
mycoplasma arthritidis, other possible etiology mechanism in RA include a breakdown in normal self
tolerance leading to reactivity to self antigens in the joint such as type-II collagen or loss of
immuno regulatory control mechanism resulting in polyclonal ‘T’ cell activation. Superantigens are
protein with the capacity to bind to HLA-DR molecules and particular Vâ segments of the
heterodimetric T cell receptor and stimulate specific T cell expressive the Vâ gene products.
Of all the potential environmental triggers, the one only clearly associated with the
development of RA is cigarette smoking. Rheumatism arthritis effect females in three times more
than males it generally occurs in late third or fourth decade of their life spans.
The Ayurvedic treatment of Amavata - Rheumatoid arthritis is being increasingly recognized
as an alternate approach to its treatment. The modern treatment of this disease is not very
satisfactory and is often attended with serious reactions. As such efforts are being persistently
made for this dreadful disease. An important aspect of Ayurvedic treatment is its easy availability
and abundance of its ingredients.
According to Ayurveda some of etiological factors such as Viruddhahara (Improper &
irregular dietary habits), Viruddhachesta (Improper Physical and Psychological activities),
Mandagni, Sedentary habits and exercise immediately after food are said to be responsible for
the origin of Amavata.
References
1. Harrison’s Principle of Internal medicine: 15th Edition Page: 2083, Vol-II.
2. Madhav Nidana, Chapter 25,
185
Various studies on Amavata-Rheumatoid arthritis have been published in the JRAS and
other scientific journals. Some of the important publications dealing with development of diseases,
the Ayurvedic concepts of its etiopathogenesis, the dietetic management and effect of certain
therapies are presented in this compilation on Amavata.
The Agnimandhya-Grahani Dosa has been considered to be the main factor in pathogenesis
of this disease in Ayurveda. Certain studies have been conducted and reviewed to assess the
gastro-intestinal function. The findings indicate impaired secretion of gastric acid secretion, deranged
liver function and reduced intestinal absorption.
The cardinal features of Amavata are swelling and pain like scorpion bite over the joints
like hands and legs (especially knee, ankle wrist, metacarpals and metatarsals). Based on the
cardinal feature and other associated features, many effective regimens are described in Ayurvedic
classics.
Owing to the gravity of the situation, a need is felt for searching the safe /effective
Ayurvedic formulations to reduce the symptoms. Keeping all these view in consideration and the
public health needs, the council intends to initiate scientific studies on well known and safe classical
Ayurvedic formulation that is being successfully prescribed by Ayurvedic physicians without any
side effects since centuries.
For the present study, coded Ayurvedic drug like AYUSH-RA tab. and AYUSH-RA oil
have been taken to assess its clinical safety and efficacy.
II. OBJECTIVES
To study the effect of Guggulu, Shunti & Guduchi in rheumatoid arthritis
III. CENTRES
CCRAS identified Centres
IV. SAMPLE SIZE AND METHODS
Sample Size : 50 cases in each center
Trial period : 18 months
Design of the study : Open observational Trial.
Drug & dosage : Tab. AYUSH-RA 2gm twice daily after food and
AYUSH - RA oil for external application 2 to 3
time daily.
Duration of the study : 45 days drug therapy with a follow up for 15
days without drug.
186
Study period : 1 year to complete study.
Follow – Up : The follow-up will be carried out after 15 days of
treatment.
V. CRITERIA FOR INCLUSION
• Age between 35 - 65 years of either sex
• Presence of any four of the following seven criteria (according 1987, revised criteria of
American College of Rheumatology)
(a) Morning stiffness: Stiffness in and around joints lasting one hour before maximal
improvement (More than 6 week’s duration).
(b) Arthritis of three or more joints (at lest three joint area, observed by Physician
simultaneously having pain with soft tissue swelling or joint effusion, not just bony
over growth) (More than 6 weeks duration).
(c) Arthritis of Hand joints (More than 6 weeks duration).
(d) Symmetric arthritis (More than 6 week’s duration).
(e) Presence of Rheumatoid Nodules
(f) Serum Rheumatoid factor- positive
(g) Typical Radiographic changes of arthritis on PA view of hand & wrist radiograph
that must include erosions or unequivocal bony decalcification adjacent to involve
joints.
VI. CRITERIA FOR EXCLUSION
1. Age below 35 and above 60 years.
2. Patients who develop secondary complication of RA e.g. Pleuro-pericardial disease,
severely damaged joint with bed ridden patients.
3. Any other serious illness e.g. Hepatic/ renal failure.
4. Patient with diagnosed other arthritis like Gouty arthritis, tuberculosis arthritis etc.
5. Patient receiving any other method of treatment.
VII. CRITERIA FOR WITHDRAWAL
The cases with following complications will be withdrawn from the study.
1. Aggravation of the disease during the course of the trial period.
2. Discontinuation of the treatment during trial.
187
3. Development of any serious complications requiring change in the treatment.
VIII. ROUTINE EXAMINATION AND ASSESSMENT
• The full details of history and physical examination of the patients will be recorded as per
the proforma (Forms I & IA).
• Clinical assessment will be done and recorded on ‘0’ day, 15th day, 30th day, 45th day
and 60th day.
• Laboratory investigation will be done before and after treatment i.e. on ‘0’and 45th day.
IX. METHOD OF ASSESSMENT OF TREATMENT
The changes in the subjective and objective parameters before and after the treatment shall
be considered for assessment of the safety and efficacy the drug.
1. Clinical Assessment
Clinical assessment will be done (symptoms graded from 0 to 3) and recorded on the
zero day (i.e. one day before administering the trial drug), after completion of the treatment period
(i.e. on 45th day of the treatment) and on the final day of the follow-up (i.e. on 60th day).
Joint pain:
Morning stiffness:
188
Tenderness:
Swelling:
The circumference of swollen Proximal inter Phalangeal joints (PIPj) and big / major joints
are measured with simple measuring methods (soft & thin tape). (only a maximum of 3 PIPj & 3
major joints are to be measured indicating the names of the joints measured for the follow-up)
Swelling:
189
2. Functional assessments
Apart from this walking time in seconds, gripping power, pressing power using inflated mercury
manometer and writing time before treatment and once in every 15 days would be recorded till
the completion of the treatment.
a) Functional tests: To have an objective view of the improvements in the functions of the
affected joints, periodical functional tests have been done (Loxton, et al. 1952 and By-
waters et.al.,1950)
• Walking time: Patients were asked to walk a distance of 150 ft. and time taken has
been recorded.
190
• Grip power: Patients were asked to squeeze the inflated cuff up to 50 mmHg of the
sphygmomanometer and the grip power has been recorded in m.ms. of mercury depending
upon the rise of mercury column.
• Pressing power: Similarly when the patient presses the same inflated cuff up to 50 mmHg
against a table then it is recorded as pressing power.
191
Sl. Grip power Grade Score
1 If the scale shows between Zero 0
50-55 mmHg
2 between 56 - 65 mmHg I 2
3 between 66 - 75 mmHg II 4
4 between 76 - 85 mmHg III 6
5 86 mmHg & above IV 8
192
X. STATISTICAL ANALYSIS
Data of clinical symptoms, physiological parameters and laboratory parameters will be
tabulated and analyzed by using appropriate statistical methods. The data of each case will have
to be communicated on completion of trial therapy to the Statistical Officer of CCRAS through e-
mail for analysis
XI. TRIAL MONITORING AND DATA ANALYSES
The progress of the trial will be monitored through field visits by monitoring unit of
CCRAS. Data analysis will be undertaken at the Monitoring Unit of CCRAS.
XII. ETHICAL REVIEW
A. Ethical Committee (IEC): The proposal will be placed before Ethical Committee
(IEC) of trial center for getting clearance certificate before the project is initiated. Patient’s
information sheet and informed consent form will be submitted along with project proposal for
approval by EC. Both will be maintained in duplicate with one copy given to the patient at the
time of entry to the trial.
B. Data and safety monitoring board: A Data and safety monitoring board (DSMB)
at Hqrs will carefully monitor the data and side effects during the period of study and put in a
place where by prompt reporting of adverse events occur. The data will be reviewed as every 20
participants entered the study and administered the trial drugs. The research team will report
immediately to the PI and Data Monitoring Board 1) any life threatening conditions whether they
are perceived to be study related or not. The Board decides whether the adverse effects warrant
discontinuation of the study protocol. Protocols will be written and approved for the treatment of
study related adverse events
XIII. TRAVELING EXPENSES FOR RESEARCH SUBJECTS
A consolidated amount of Rs. ………. /- per visit will be given i.e., on the 1st day of
recruitment after screening, 15th day, 30th day 45th day and 60th day.
XIV. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
Short-term two-day training will be provided to the Investigators involved in the
multicentric trial at CCRAS Hqrs. New Delhi. The investigators will be detailed about the clinical
trial conduct and laboratory procedures in order to maintain the uniformity.
XV. LABORATORY INVESTIGATIONS
The Laboratory Investigations (Pathological/Biochemical, etc.), which are not available at
research Institutes should be conducted at identified reputed labs /Government Institutes under
intimation to this Council following codal formalities.
193
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL VALIDATION OF GUGGULU, SHUNTI & GUDUCHI IN
RHEUMATOID ARTHRITIS
CONSENT FORM
CERTIFICATE BY INVESTIGATOR
I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature of the subject: ______________
Name: ____________________________
CONSENT BY SUBJECT
The attending physician, the purpose of the clinical trial and the nature of drug treatment
and follow-up have informed me to my satisfaction, including the laboratory investigations to be
performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so. I am willing to undergo any risk for inclusion in
this study.
I, exercising my free power of choice, hereby give my consent to be included as a subject
in the clinical validation of guggulu, shunti & guduchi in rheumatoid arthritis.
Relationship ___________________________________
194
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL VALIDATION OF GUGGULU, SHUNTI & GUDUCHI IN
RHEUMATOID ARTHRITIS
PATIENT INFORMATION SHEET
195
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL VALIDATION OF GUGGULU, SHUNTI & GUDUCHI IN
RHEUMATOID ARTHRITIS
CASE RECORD FORM I – SCREENING
BEFORE TREATMENT
(Enter a in the appropriate box)
CASE REPORT FORM-I: SCREENING
1. Centre: ………………..……….
196
(e) Presence of Rheumatoid Nodules
If Yes to Sl. No. 1 & 2 and No to Sl. No. 3 to 7 above, admit the subject to the trial.
197
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL VALIDATION OF GUGGULU, SHUNTI & GUDUCHI IN
RHEUMATOID ARTHRITIS
CASE REPORT FORM II – HISTORY
1. Centre: ………………..……….
7. Address ……………………………………..……………..........…………………………
8. Educational status: Illiterate (1) Read and Write(2) Primary School (3)
198
HISTORY OF PRESENT ILLNESS:
13. Tenderness
14. Fever
FUNCTIONAL ASSESSMENT
Personal History:
199
Addiction
If irregular, Specify___________________________
If abnormal, Specify__________________________________
Sannipataj (7)
Physical Examination
200
32. Pulse (per min) ____________
37. CVS
If abnormal, details_____________________________________________
38. CNS
42. Vision
201
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL VALIDATION OF GUGGULU, SHUNTI & GUDUCHI IN
RHEUMATOID ARTHRITIS
CASE REPORT FORM III - CLINICAL ASSESSMENT
(On 0th Day)
1. Centre: ………………..……….
7. Date of Assessment:
8. Pain in Joints
9. Swelling in joints
11. Tenderness
12. Fever
202
FUNCTIONAL ASSESSMENT
203
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
1. Centre: ………………..……….
6. Date of Assessment:
7. Pain in Joints
9. Swelling in joints
12. Tenderness
13. Fever
204
FUNCTIONAL ASSESSMENT
205
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
1. Centre: ………………..……….
6. Date of Assessment:
7. Pain in Joints
9. Swelling in joints
12. Tenderness
13. Fever
206
FUNCTIONAL ASSESSMENT
207
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
1. Centre: ………………..……….
6. Date of Assessment:
7. Pain in Joints
9. Swelling in joints
12. Tenderness
13. Fever
208
FUNCTIONAL ASSESSMENT
209
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
1. Centre: ………………..……….
6. Date of Assessment:
7. Pain in Joints
8. Swelling in joints
9. Morning stiffness
10. Tenderness
11. Fever
210
FUNCTIONAL ASSESSMENT
211
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL VALIDATION OF GUGGULU, SHUNTI & GUDUCHI IN
RHEUMATOID ARTHRITIS
FORM IV – LABORATORY INVESTIGATIONS
(0th day)
1. Centre: ………………..……….
7. Date of Assessment:
8. Stage of Assessment
9. Urine Examination:
Routine____________ Microscopic___________
Blood Examination
212
14. ESR (1st hour.)(mm) ____________________
213
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL VALIDATION OF GUGGULU, SHUNTI & GUDUCHI IN
RHEUMATOID ARTHRITIS
FORM IV – LABORATORY INVESTIGATIONS
(60th day)
1. Centre: ………………..……….
7. Date of Assessment:
8. Stage of Assessment
9. Urine Examination:
Routine____________ Microscopic___________
Blood Examination
214
14. ESR (1st hour.) (mm) ____________________
215
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL VALIDATION OF GUGGULU, SHUNTI & GUDUCHI IN
RHEUMATOID ARTHRITIS
CASE RECORD FORM V
CONSOLIDATED DATA ON PERIODICAL OBSERVATIONS
1. Centre: ………………..……….
216
8. Pressing power
in mm Hg
9. Other Associated Symptoms if Any [Specify]
217
23. Total (mg/dl)
24. Direct (mg/dl)
25. SGPT (IU/L)
26. SGOT (IU/L)
27. S. Alkaline Not Not
phosphatase Applicable Applicable
(U/L)
28. S. Proteins
(Total) (g/dl)
29. Albumin (g/dl)
30. Globulin (g/dl)
31. Renal function tests
32. Blood urea Not Not
(mg/dl) applicable applicable
33. S. Creatinine
(mg/dl)
34. Urine Examination
Routine Not Not
Albumin (g/dl) applicable applicable
Globulin (g/dl)
Microscopic
RBC Not Not
Pus Cells applicable applicable
Epithelial Cells
35. Stool Examination
Occult Blood Not Not
applicable applicable
Ova/Cyst Not Not
applicable applicable
Microscopic
RBC Not Not
Pus Cells applicable applicable
Epithelial Cells
218
7. Overall clinical assessment
Continuing: (1)
219
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
DRUG COMPLIANCE REPORT FORM – I
CLINICAL VALIDATION OF GUGGULU, SHUNTI & GUDUCHI IN
RHEUMATOID ARTHRITIS
(To be filled by the trial participant)
(To be issued on 1st visit – 0 day and taken back on 2nd visit –15th day)
Please come for next visit on ................................. (Date and time is to be filled by the Investigator)
• Please take tab. AYUSH-RA 2 gm. twice a day after food with a glass of luke warm water
(approx. 250 ml.) maintaining 12 hours gap in between.
• Please return the empty strip after taking medicine along with the compliance report duly
filled.
• Please come with empty stomach and bring breakfast along with you during next visit.
Day Date Morning dose (around 9 AM) Evening dose (around 9 PM)
Please put Please enter Please put Please enter
mark after the time mark after the time
taking the taking the
medicine medicine
1.
2.
3.
4.
5.
220
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
Date: ...........................................
221
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
DRUG COMPLIANCE REPORT FORM – II
CLINICAL VALIDATION OF GUGGULU, SHUNTI & GUDUCHI IN
RHEUMATOID ARTHRITIS
(To be filled by the trial participant)
(To be issued on 2nd visit – 16th day and taken back on 3rd visit –30th day)
Please come for next visit on ................................. (Date and time is to be filled by the Investigator)
• Please take tab. AYUSH-RA 2 gm. twice a day after food with a glass of luke warm water
(approx. 250 ml.) maintaining 12 hours gap in between.
• Please return the empty strip after taking medicine along with the compliance report duly
filled.
• Please come with empty stomach and bring breakfast along with you during next visit.
Day Date Morning dose (around 9 AM) Evening dose (around 9 PM)
Please put Please enter Please put Please enter
mark after the time mark after the time
taking the taking the
medicine medicine
16.
17.
18.
19.
20.
222
21.
22.
23.
24.
25.
26.
27.
28.
29.
30.
Date: ...........................................
223
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
DRUG COMPLIANCE REPORT FORM – III
CLINICAL VALIDATION OF GUGGULU, SHUNTI & GUDUCHI IN
RHEUMATOID ARTHRITIS
(To be filled by the trial participant)
(To be issued on 3rd visit – 31st day and taken back on 3rd visit –45th day)
Please come for next visit on ................................. (Date and time is to be filled by the Investigator)
• Please take tab. AYUSH-RA 2 gm. twice a day after food with a glass of luke warm water
(approx. 250 ml.) maintaining 12 hours gap in between.
• Please return the empty strip after taking medicine along with the compliance report duly
filled.
• Please come with empty stomach and bring breakfast along with you during next visit.
Day Date Morning dose (around 9 AM) Evening dose (around 9 PM)
Please put Please enter Please put Please enter
mark after the time mark after the time
taking the taking the
medicine medicine
31.
32.
33.
34.
35.
224
36.
37.
38.
39.
40.
41.
42.
43.
44.
45.
Date: ...........................................
225
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
DRUG COMPLIANCE REPORT FORM – IV
CLINICAL VALIDATION OF GUGGULU, SHUNTI & GUDUCHI IN
RHEUMATOID ARTHRITIS
(To be filled by the trial participant)
(To be issued on 3rd visit – 46th day and taken back on 4th visit – 60th day)
Please come for next visit on ................................. (Date and time is to be filled by the Investigator)
• Please take tab. AYUSH-RA 2 gm. twice a day after food with a glass of luke warm water
(approx. 250 ml.) maintaining 12 hours gap in between.
• Please return the empty strip after taking medicine along with the compliance report duly
filled.
• Please come with empty stomach and bring breakfast along with you during next visit.
Day Date Morning dose (around 9 AM) Evening dose (around 9 PM)
Please put Please enter Please put Please enter
mark after the time mark after the time
taking the taking the
medicine medicine
46.
47.
48.
49.
50.
226
51.
52.
53.
54.
55.
56.
57.
58.
59.
60.
Date: ...........................................
227
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL VALIDATION OF GUGGULU, SHUNTI & GUDUCHI IN
RHEUMATOID ARTHRITIS
RECIEPT
228
PROTOCOL FOR DOUBLE BLIND CLINICAL TRIAL
FOR THE TREATMENT OF OSETOPOROSIS
229
Blank
230
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
PROTOCOL FOR DOUBLE BLIND CLINICAL TRIAL FOR THE
TREATMENT OF OSETOPOROSIS
I. BACKGROUND
Pommer coined the term osteoporosis in 1885, which literally means increased porosity of
Bones.
It is described as a systemic skeletal disease characterized by low bone mass and micro
architectural detoriation of bone tissues with a consequent increase in bone fragility and susceptibility
to fracture. The magnitude of the problem has not been fully understood and the incidence of
osteoporosis is highly increased due to increased life span and greater awareness of the disease
since 1980 (Rosen et al, 1997). In recent study the following observations were made.
1) Osteoporosis1 occurs both in males and females in India.
2) Osteoporotic fractures occur more commonly in Indian males than females.
3) Osteoporotic fractures occur 10-20 years earlier in Indian men and women compared to
west (Wali, T.P. etal)
Certain factors like Genetic, personal life style factors like smoking, alcoholism lower
intake of calcium, non-exposure to sunlight and certain diseases predispose this disease.
In Ayurveda under the heading “Asthi kshaya” many signs and symptoms described can
closely be correlated with this clinical entity. This has also been treated with herbal and herbo
minerals since very remote past. In recent years the advancement in the field of Phytochemistry
and clinical trials, it has been evinced the role of certain herbals like Cissus quardrangularis in the
treatment of bone fracture. The phytochemical studies have also established the presence of
phytosterol, phytoestrogen and calcium. Embica officinalis is an anti-oxidant and thereby stabilizes
Vitamine-D metabolites or their conjugates present in the primary ingredient. Further it is
considered to promote collagen metabolism by virtue of its Vitamine-C like activity. Now
combination of Asthi Shrankhala( Cissus quardrangularis) and Amalki( Embica officinalis ) is
being taken up for study.
References
1. Harisson’s Principles of internal medicine, Volume-1, 14th Edition, International Editions, 1998, Published
by McGraw-Hill CompaniesInc.pp1208-1209
2. Bhaisajya Ratnavali, Chaukhamba Sanskrit Samsthan, Varanasi
231
In modern medicine this disease is managed with, Hormone replacement therapy and also
with calcium and Vitamin ‘D’ which is considered as anti resorptive and stimulator of Bone turn
over. But these drugs do have side effects like nausea, vomiting and diarrhea. In this contest the
natural calcium, which is safe, less toxic, and does not have any side effect will be taken for
study.
II. OBJECTIVES:
To assess the therapeutic efficacy of an Ayurvedic coded trial drug AYUSH B-caps in the
treatment of osteoporosis in comparison with standard control drug Calcium with Vitamin- D3.
III. CENTRES
CCRAS identified centers
IV. SAMPLE SIZE & METHODS
Groups : Two – trial and control [50 (25 male and 25 female) cases
in each group (Control drug will be made similar to trial
drug and one placebo draggee will be prescribed after
dinner)
Group-I : Trial drug
Group-II : Control drug
Trial Design : Double blind randomized
Drug/Dosage/Duation:
Trial drug : Coded drug AYUSH B –Two caps 500 mg each twice a
day.
Control drug : Control drug 500 mg twice a day.
Duration of : One year
Treatment
Period of Study : One year for each case.
Total duration : will be Two years to complete the study.
V. CRITERIA FOR INCLUSION
1. Age: Patients of both sexes above 45 years and up to 70 years.
2. B.M.D. T. Score below – 1.5
232
The cases for carrying out BMD T Score will be screened with the following targeted
patients:
1. Post menopausal woman with early menopause (40 years and below) and familial
prevalence.
2. Patients with osteopenia or spinal deformities on spine-x-rays.
3. Patients on long-term cortico steroids for more than six months.
4. Patients with history of osteoporosis related fractures.
VI. CRITERIA FOR EXCLUSION
1. Age below 45 and above 70
2. T. Score below –1.5
3. Primary Hyper parathyroidsim
4. Thyrotoxicosis
5. Addison’s disease
6. Cushing syndrome
7. Rheumatoid arthritis
8. Malabsorption syndrome
9. Chronic liver diseases
10. Organ transplantation
11. Chronic renal failure
12. Prolonged immobilization
13. Diabetes (Uncontrolled)
14. Cases undergoing treatment for osteoporosis
15. Cases undergoing treatment for any other serious illness.
VII. CRITERIA FOR WITHDRAWAL
During the course of the trial there may be certain potential adverse threats like Kidney
stones, hypocalcaemia with renal insufficiency (milk alkali syndrome) and interference of calcium
with other essential nutrients. If any other side effects and other symptoms are observed then the
trial drugs will be withdrawn and will be treated symptomatically.
233
VIII. ROUTINE EXAMINATION AND ASSESSMENT
Clinical assessment will be done (O), at the end of 1st, 2nd and every subsequent month
till the completion of treatment (Form 2). The Lab investigations (Biochemical markers) will be
recorded before drug administration (O month) and after every two months till the completion of
trial (0, 2nd, 4th, 6th, 8th, 10th and 12th months i.e. the end of the treatment). The B.M.D. will be
done before and after the completion of the treatment.
IX. CRITERIA FOR ASSESMENT
30% or more in B.M.D. T. Score (above –1.5 level) increase will be considered as
significant improvement. .
X. STATISTICAL ANALYSIS
Data on BMD T-Score will be analyzed using appropriate statistical tools. (Null
Hypothesis: There is no significant difference between the BMD T-score in the treated group and
control group).
XI. TRIAL MONITORING AND DATA ANALYSIS
CCRAS, HQ’s Office New Delhi will monitor the progress of the trial
XII. ETHICAL REVIEW
Clearance certificate from Institutional Ethical Committee (IEC) or Head of the Institution
should be obtained before the Project is initiated. IEC/Head of the Institution should submit
patient’s information sheet and informed consent form along with project proposal for approval.
Both of these forms should be maintained in duplicate with one copy given to the patient at the
time of entry to the trial.
The change between two BMD can be expressed in the form of (%) percentage between two measurements
or by absolute change in gm/cm between two measurements.
Percentage change is calculated as I BMD – II BMD x 100
I BMD
= (%) percentage change.
Absolute change is calculated as I BMD – II BMD
Absolute change
234
XIII. TRAVELING EXPENSES FOR RESEARCH SUBJECTS
A consolidated amount of Rs. ___________ per visit.
XIV. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
Short-term two-day training will be provided to the Investigators and Laboratory
personnel involved in the trial at CCRAS Hqrs. The investigators and technicians will be detailed
about the clinical trial conduct and laboratory procedures in order to maintain the uniformity.
XV. LABORATORY INVESTIGATIONS
The Laboratory Investigations (Pathological/Biochemical, etc.), which are not available at
research Institutes should be conducted at identified reputed labs /Government Institutes under
intimation to this Council following codal formalities.
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
PROTOCOL FOR DOUBLE BLIND CLINICAL TRIAL FOR THE
TREATMENT OF OSETOPOROSIS
WRITTEN INFORMED CONSENT FORM
CERTIFICATE BY INVESTIGATOR
I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature of the subject: ______________
Name: ____________________________
CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending physician, the purpose of the
clinical trial and the nature of drug treatment and follow-up, including the laboratory investigations
to be performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so. I am willing to undergo any risk for inclusion in
this study.
I, exercising my free power of choice, hereby give my consent to be included as a subject
in the “Double blind clinical trial for the treatment of Osetoporosis”.
Relationship ___________________________________
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
DOUBLE BLIND CLINICAL TRIAL FOR THE TREATMENT OF
OSETOPOROSIS
PATIENT INFORMATION SHEET
237
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
DOUBLE BLIND CLINICAL TRIAL OF AYURVEDIC FORMULATION IN
THE TREATMENT OF OSETOPOROSIS
CASE REPORT FORM I – SCREENING
(Enter a in the appropriate box)
1. Centre: ………………..……….
6. Address ……………………………………..………………………………………
5. Thyrotoxicosis
7. Cushing syndrome
8. Rheumatoid Arthritis
9. Mal-absorption syndrome
238
11. Organ Transplantation
If ‘Yes’ to 1 and 2 & ‘No’ to 3 – 16 above, admit the subject to the trial. If admitted,
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
DOUBLE BLIND CLINICAL TRIAL OF AYURVEDIC FORMULATION IN THE
TREATMENT OF OSETOPOROSIS
CASE REPORT FORM II – HISTORY
1. Centre: ………………..……….
7. Address ……………………………………..……………..........…………………………
8. Educational status: Illiterate (1) Read and Write(2) Primary School (3)
10. Smoking
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11. Tobacco
12. Alcohol
Sannipataj (7)
Physical Examination
241
SURGICAL HISTORY No (0) Yes (1)
24. Hysterectomy
25. Oophorectomy
27. Steroids
31. Kyphosis
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
DOUBLE BLIND CLINICAL TRIAL OF AYURVEDIC FORMULATION IN THE
TREATMENT OF OSETOPOROSIS
CASE REPORT FORM III -PERIODICAL OBSERVATION AND ASSESSMENT
1. Centre: ………………..……….
7. Date of Assessment:
8. Month of Assessment :
9. Skeletal Pain
10. Kyphosis
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
DOUBLE BLIND CLINICAL TRIAL OF AYURVEDIC FORMULATION IN THE
TREATMENT OF OSTEOPOROSIS
CASE REPORT FORM IV-A – LABORATORY INVESTIGATIONS
1. Centre: ………………..……….
7. Date of Assessment:
8. Month of Assessment :
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ANORECTAL DISORSERS
SECTION - IV
245
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MULTI CENTRIC OPEN CLINICAL TRIAL ON THE
MANAGEMENT OF FISSURE-IN-ANO (PARIKARTIKA)
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTI CENTRIC OPEN CLINICAL TRIAL ON THE MANAGEMENT OF
FISSURE-IN-ANO (PARIKARTIKA1)
I. BACKGROUND
An Anal Fissure is a tear in the skin around the opening of the Anus1. It can cause sharp
pain, especially when opening the bowels. Anal Fissure is thought to be a common disorder for
which many people do not seek medical advice. The internal anal sphincter is thought to play a
key role in the development of an Anal Fissure. This is one of two muscles that control the
opening of the anus. Both muscles need to relax in order to pass a stool. Unlike the exterior anal
sphincter, which can be tensed or relaxed voluntarily, there is no voluntary control of the internal
sphincter. Because of the pain of a fissure, the internal anal sphincter may go into spasm - causing
a raised pressure within the anus. This excess pressure makes it harder to pass a stool, making
constipation worse, and contributing to a vicious circle. The spasm of the internal anal sphincter
can also restrict the blood supply to the anal skin, which reduces its ability to heal.
The condition Parikartika has been mentioned in the Ayurvedic literature as one of the
fifteen kinds of disorders which may result from an injudicious use of purgatives owing to the
ignorance of the physician or of the patient. Improperly done virechana karma (purgatives)
aggravates the Vata & Pitta that gives rise to a sort of cutting, sawing pain in the anus, penis,
umbilical region and the neck of the bladder (Vasti). The omission of flatus is arrested the Vayu
lies incarcerated in the abdomen and relish for food vanishes.
Application of Creams or Ointments that contain local anaesthetics (eg lidocaine) or
steroids (eg hydrocortisone) and an injection of outline toxin (Botox), anal dilatation,
sphincterotomy, and fissurectomy (chronic fissure) are usually in practice. But these procedures
have sometimes associated with some complications like post operative anal stenosis, sphincter
incontinence etc. To overcome such problems and to provide cheap, simple, ambulatory and
effective treatment, different treatment modalities have been kept on trial on the basis of the
treatment mentioned in the ancient literature and also based on the preliminary work done in the
management. Earlier workers have tried Kaseesadi Taila Vasti, Jatyadi Ghtrita per rectal
application, hot sitz bath and a laxative, taking lead from the ancient classics especially descriptions
described about the use of Picchavasti and Anuvasana Vasti in the treatment of parikartika.
Though different regimens have proved to be efficacious in the treatment of fissure-in-ano, patients
References
1. Charak Siddhi sthana 6/29
249
feel difficulty in pushing of Kaseesadi Taila in to the anal canal. Sometimes there was an
immediate spillage of oil after pushing due to spasm of the sphincter. More over it was found
difficult to assess which procedure was more effective in the combined therapy of pushing of oil
and application of ghee manually per rectally. In order to see the efficacy of various procedures
individually, it was thought to try different therapeutic regimens in present study beside the
development of a novel method of dilatation of anal canal to see the effect of different procedures
/ drugs in the management of fissure-in-ano.
II. OBJECTIVES
• To provide symptomatic relief in shorter duration
• To provide healing to the fissure-in-ano
• To find out a simple, amble, safe & cost effective therapeutic regimen or procedure in the
management of fissure-in-ano
III. CENTRES
CCRAS identified Centers.
IV. SAMPLE SIZE AND METHODS
Sample size : 40 subjects per centre
Trial Drug /Dosage :
Group: I
• Triphala churna; 5gm with warm water daily at bedtime for 28 days
• A novel method of Anal dilatation for 07 days
• Hot Sitz bath for 28 days Anal dilatation:
A self retaining Foley’s rubber catheter no. 18 is smeared with 2% lignocaine jelly and
inserted in the anal canal up to 4 cm. from the tip and on the first day the bulb is inflated with 5
ml of water and gently pull the catheter downward till it sustains maximum resistance and the
catheter is allowed to stay in position for one minute. Then the water is withdrawn from the bulb
and the catheter is removed from the anal canal. After removing the catheter the patient is given
hot sitz bath for two minutes. The catheter is sterilized properly and reused in the same patient for
next sittings.
The procedure remains unchanged except in the increase in the volume of the water from
5ml to different volumes as indicated below:
Day 1 : 5ml
250
Day 2 : 7ml
Day 3 : 10ml
Day 4 : 15ml
Day 5 : 20ml
Day 6 : 20ml
Day 7 : 20ml
Group: II
• Triphala churna; 5gm with warm water daily at bed time for 28 days
• Anal dilatation with Jatyadi Ghrita for 07 days
• Hot Sitz bath for 28 days
Anal dilatation:
Take sufficient quantity of Jatyadi Ghritam in a sterile bowl. Initially the little finger (goved)
is well smeared with the Ghritam and gently inserted in the Anal Canal watching the resistance
produced by the sphincter. Care should be taken to push the finger always against the non-ulcer
wall of the Anal Canal and inwards. After the little finger is inserted in to the canal allow to remain
the finger in the canal for one minute. Then the finger is withdrawn slowly and then index finger is
inserted following the same principle and wait for two minutes. Then index and middle fingers are
inserted together and kept for three minutes in the canal. Care should be taken that the fingers
and the anal canal are well lubricated with the Ghritam. After the procedures are completed the
patient is allowed hot sitz bath for three minutes. The same procedure is to be carried out for
seven days.
Group: III
• Triphala Churna; 5gm with warm water daily at bed time for 28 days
• Hot Sitz bath for 28 days
• Application of Jatyadi Ghrita (P/R) (without dilatation) for 07 days
Application of Jatyadi Ghrita (P/R)
The patient is first asked to take hot sitz bath then with the help of gloved little finger the
Jatyadi Ghritam is applied gently in the Anal Canal without applying much pressure in the Canal.
The same procedure is to be carried out for seven days.
251
Duration of the trial : Total six weeks: (28 days as per the schedule
given under each group and last two weeks
follow-up without any medication.
Design of the Study : Open trial
V. CRITERIA FOR INCLUSION
Selection of cases : Any age of either sex with complains of Pain with or without
bleeding per rectum during and/or after the defecation with or without other symptoms like, itching,
discharge, constipation, with /or without pain are examined and confirmed by peri-anal
examination are admitted for the study.
The cases are randomly selected irrespective of age, sex, chronicity, Prakriti and type of
fissure.
VI. CRITERIA FOR EXCLUSION
The cases associated with malignancy were excluded from the study.
VII CRITERIA FOR WITHDRAWAL
During the course of the trial treatment, if any serious condition or any serious adverse
events which requires urgent treatment or if patients themselves want to withdraw from the study,
such subjects may be withdrawn from the trial.
VIII. ROUTINE EXAMINATION AND ASSESSMENT
The full details of screening, history and physical examination of the subjects will be
recorded as per case record form I & II. Clinical and physiological assessment in form III and
laboratory investigations in forms IV will be done regularly.
IX. CRITERIA OF ASSESSMENT
Since the pain is the main symptom in Fissure-in-ano, a total number of days taken to
heal the ulcer with alleviation of pain and associated symptoms are noted and results are assessed
in the following manner.
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2 Partial 08 – 14 When there is complete relief in pain during/after
Response days defecation without bleeding after 7 days but before 14
days of the therapy and no recurrence thereafter up to 6
weeks of the follow-up.
3 Poor 15 – 21 Complete relief in pain after 14 days but before 21 days
Response days of the treatment without bleeding and recurrence
thereafter up to 6 weeks of the follow-up.
4 No 22 days & When there is any relief in pain or partial relief or relief
Response above in pain after 22 days of the therapy and/or recurrence
thereafter.
5 Drop-out Drop-out Discontinuation of the treatment during the trial due to
development of any complications & aggravation of the
disease.
X. STATISTICAL ANALYSIS
Data on intensity of pain, duration of pain will be tabulated and analysed by using
appropriate statistical methods.
However the data of each case will have to be communicated on completion of trial
therapy to the Statistical Officer of CCRAS through e-mail.
XI. TRIAL MONITORING AND DATA ANALYSIS:
The progress of the trial will be monitored by field visits by monitoring unit of CCRAS.
Data analysis will be undertaken at the Monitoring Unit of CCRAS.
XII. ETHICAL REVIEW:
A. Ethical Committee (IEC): The proposal will be placed before Ethical Committee
(IEC) of trial center for getting clearance certificate before the project is initiated. Patient’s
information sheet and informed consent form will be submitted along with project proposal for
approval by IEC. Both will be maintained in duplicate with one copy given to the patient at the
time of entry to the trial.
B. Data and Safety Monitoring Board: A Data and safety monitoring board (DSMB)
at Hqrs. will carefully monitor the data and side effects during the period of study and put in a
place where by prompt reporting of adverse events occur. The data will be reviewed as every 20
participants entered the study and administered the trial drugs. The research team will report
immediately to the PI and Data Monitoring Board 1) any life threatening conditions whether they
are perceived to be study related or not. The Board decides whether the adverse effects warrant
253
discontinuation of the study protocol. Protocols will be written and approved for the treatment of
study related adverse events
XIII. TRAVELING EXPENSES FOR RESEARCH SUBJECTS
A consolidated amount of Rs.______ /- per visit i.e., on the 1st day of recruitment after
screening, 3rd week, & 6th week (3 times)
XIV. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
Short-term two-day training will be provided to the Investigators involved in the
multicentric trial at CCRAS Hqrs. New Delhi. The investigators will be detailed about the clinical
trial conduct and laboratory procedures in order to maintain the uniformity.
XV. LABORATORY INVESTIGATIONS
The Laboratory Investigations (Pathological/Biochemical, etc.), which are not available at
research Institutes should be conducted at identified reputed Tabs /Government Institutes under
intimation to this Council observing requisite codal formalities.
254
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
WRITTEN INFORMED CONSENT FORM
CERTIFICATE BY INVESTIGATOR
I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature of the Investigator ___________
Name: ____________________________
CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending physician, the purpose of the
clinical trial and the nature of drug treatment and follow-up, including the laboratory investigations
to be performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so. I am willing to undergo any risk for inclusion in
this study.
Relationship ___________________________________
255
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTI CENTRIC OPEN CLINICAL TRIAL ON THE MANAGEMENT OF
FISSURE-IN-ANO (PARIKARTIKA)
PATIENT INFORMATION SHEET
256
Before you start treatment, during the first visit to the clinic, you will undergo a complete
physical examination, required objective tests and laboratory investigations will also be done.
If you are found eligible, you would be put on trial treatment for six weeks.
At each visit, you will be supplied with sufficient quantities of drugs to last until your next
visit. If any adverse reactions like skin allergy, nausea, vomiting and palpitation/tremor etc., noticed
during the treatment period, this should be noticed to the doctor who is treating you.
257
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTI CENTRIC OPEN CLINICAL TRIAL ON THE MANAGEMENT OF
FISSURE-IN-ANO (PARIKARTIKA)
CASE RECORD FORM I – SCREENING
BEFORE TREATMENT
(Enter a in the appropriate box)
CASE REPORT FORM-I: SCREENING
1. Centre: ………………..……….
6. Address ……………………………………..………………………………………
5 Bright red blood on the outside of the stool or on the toilet paper
6 Constipated bowels
CRITERIA OF EXCLUSION:
7 History of malignancy
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTI CENTRIC OPEN CLINICAL TRIAL ON THE MANAGEMENT OF
FISSURE-IN-ANO (PARIKARTIKA)
CASE REPORT FORM II – HISTORY
(Enter a in the appropriate box)
1. Centre: ………………..……….
7. Date of Assessment:
8. Address ……………………………………..……………..........…………………………
11. Family income per month in Rs. Rs. Income per capita in Rs.
Christian 4 Parsi 5
259
14. Likes: __________________________________________________________________
Tobacco
17. Allergy:
18. Surgery:
FAMILY HISTORY
Hypertension:
Diabetes:
Genetic disorders:
Psychiatric disorder:
Other:
260
25. Associated with Itching or irritation around the Anus
General Examination
31. Height
32. Weight
34. Abdomen:
Acute Chronic
261
3. Digital examination
Sphincter tone:
Treatment:
Group: I
• Triphala churna: 5gm with warm water daily at bed time for 28 days
A self retaining Foley’s rubber catheter no. 18 is smeared with 2% lignocaine jelly and
inserted in the Anal canal up to 4 cm. from the tip and on the first day the bulb is inflated with 5
ml of water and gently pull the catheter downward till it sustains maximum resistance and the
catheter is allowed to stay in position for one minute. Then the water is withdrawn from the bulb
and the catheter is removed from the Anal canal. After removing the catheter the patient is given
hot sitz bath for two minutes. The catheter is sterilized properly and reused in the same patient for
next sittings.
The procedure remains unchanged except in the increase in the volume of the water from
5ml to different volumes as indicated below:
Day 1 : 5ml
Day 2 : 7ml
Day 3 : 10ml
Day 4 : 15ml
Day 5 : 20ml
Day 6 : 20ml
262
Day 7 : 20ml
Group: II
• Triphala churna; 5gm with warm water daily at bed time for 28 days
Anal dilatation:
Take sufficient quantity of Jatyadi Ghritam in a sterile bowl. Initially the little finger (goved)
is well smeared with the Ghritam and gently inserted in the Anal canal watching the resistance
produced by the sphincter. Care should be taken to push the finger always against the non-ulcer
wall of the Anal canal and inwards. After the little finger is inserted in to the canal allow to remain
the finger in the canal for one minute. Then the finger is withdrawn slowly and then index finger is
inserted following the same principle and wait for two minutes. Then index and middle fingers are
inserted together and kept for three minutes in the canal. Care should be taken that the fingers
and the anal canal are well lubricated with the Ghritam. After the procedures are completed the
patient is allowed hot sitz bath for three minutes. The same procedure is to be carried out for
seven days.
Group: III
• Triphala churna; 5gm with warm water daily at bed time for 28 days
The patient is first asked to take hot sitz bath then with the help of gloved little finger the
Jatyadi Ghritam is applied gently in the Anal canal without applying much pressure in the canal.
The same procedure is to be carried out for seven days.
Remarks:
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTI CENTRIC OPEN CLINICAL TRIAL ON THE MANAGEMENT OF
FISSURE-IN-ANO (PARIKARTIKA)
CASE REPORT FORM III -PERIODICAL OBSERVATION AND ASSESSMENT
CASE REPORT FORM III – CLINICAL ASSESSMENT
(From day one to seventh day and subsequently on 14th, 21st, 28th, 35th &
42nd day)
Separate form should be used on each visit
(Enter a in the appropriate box)
1. Centre: ………………..……….
7. Day of Assessment: 1st, 2nd, 3rd, 4th, 5th, 6th, 7th, 14th, 21st, 28th, 35th & 42nd day
CLINICAL ASSESSMENT CHART: (Mention ‘Y’ for Yes, ‘N’ for No)
FOLLOW UP
Symptoms & Signs: Initial First month Second month Third month
Abdominal pain
-Day of onset
-Intensity
-Relief after passage
of clots
-Nature of pain
-Toda
264
- Bheda
- Sula
Low back pain
-Day of onset
-Intensity
-Relief after passage
of clots
-Nature of pain
-Toda
- Bheda
- Sula
Pain in lower limbs
Nausea / Vomiting
Constipation
Giddiness
Tenderness on palpation
Breast tenderness
Diarrhea
Headache
Fainting
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MLTI CENTRIC OPEN CLINICAL TRIAL ON THE MANAGEMENT OF
FISSURE - IN ANO (PARIKARTIKA)
CASE REPORT FORM IV - A - LABORATORY INVESTIGATIONS
(On Day 1)
(Enter a in the appropriate box)
1. Centre: ………………..……….
5. Address ................................................................................................................................
6. Date of Assessment :
7. Urine Examination
8. Stool examination
Blood Examination
10. DLC: P _____ (%) L _____ (%) E ______ (%) M _____ (%) B ______(%)
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Liver function tests
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTI CENTRIC OPEN CLINICAL TRIAL ON THE MANAGEMENT OF
FISSURE-IN-ANO (PARIKARTIKA)
(On Day 35)
CASE RECORD FORM IV-PERIODICAL OBSERVATION AND ASSESSMENT
FORM IV-B – LABORATORY INVESTIGATIONS
1. Centre: ………………..……….
7. Address: ...............................................................................................................................
8. Date of Assessment:
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTI CENTRIC OPEN CLINICAL TRIAL ON THE MANAGEMENT OF
FISSURE-IN-ANO (PARIKARTIKA)
CASE RECORD FORM V-CONSOLIDATED DATA ON PERIODICAL
OBSERVATIONS
(Enter a in the appropriate box)
1. Centre: ………………..……….
7. Address: ...............................................................................................................................
8. Date of Assessment:
269
Microcytic Hypochromic
Macrocytic Normo/
hypochromic
7. Liver function tests
S. Bilirubin (mg/dl)
SGPT (IU/L)
SGOT (IU/L)
S. Alkaline phosphatase
(KA unit)
S. Proteins (gm/dl)
8. Renal function tests
Blood urea (mg/dl)
S.Creatinine(mg/dl)
Continuing
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COMPARATIVE CLINICAL EVALUATION OF SELECT
AYURVEDIC TREATMENT MODALITIES IN THE
MANAGEMENT OF ARSHA
271
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
COMPARATIVE CLINICAL EVALUATION OF SELECT AYURVEDIC
TREATMENT MODALITIES IN THE MANAGEMENT OF ARSHA
I. BACKGROUND
Concept of Arsha as described in Ayurveda is quite wider. ‘Arsha’ includes a variety of
conditions pertaining to Ano-rectal and other parts/organs of the body. Present study includes
conditions pertaining to Ano-rectal Arsha. Only Sushruta has described four fold methods of
treatments of Arsha (Su. Ci. 6), which are Bheshaja, Kshara, Agni and Shastra. Bheshaja i.e.
Medical/conservative treatment includes various Ayurvedic medicines which decrease intra-
abdominal pressure, act as mild laxatives and thus give relief in the particular situation. Some other
Oils/like Kashishadi taila when used locally (Lekhana) imparts relief in Arsha. The commonly used
medicines are – Abhayarishta, Draksharishta, Satsakara churna, Triphala churna, Satpushpadi
churna etc. Locally Kashishadi tila and inflammatory conditions Jatyadi taila are prescribed.
In certain other cases Ksarakarma and Ksharasutra are used effectively. Plain thread
ligation of prolapsible internal haemorrhoids is also a popular method of treating the haemorrhoids
on OPD basis (Sharma, 1999). Raktavasecana, Agnikarma and Shastrakarma are some other
methods. However the Shastrakarma needs general/spinal anaesthesia. Bheshaja (Medicine)
treatment is the most suitable treatment in the Arsha of:
• Rectal origin
• History of mild/moderate bleeding
• Small, negligible or invisible haemorrhoidal mass
• Associated with diarrhoea/dysentery
References
1. Baily and Love – Short practice of surgery, 24th Edition, 2004, Arnold Publication, London
2. Charaka Samhita, Chikitsa Sthana, Arsha Chikitsa, Chapter–15, Vidyotini Hindi Vyakhya by Pt.
Kashinath, Choukhamba Orientalia, Varanasi
3. Bhaisajya Ratnavali, Krimiroga Chikitsa Prakarana, Chaukhamba Sanskrit Samsthan, Varanasi
4. Ambika Dutta Sashtri(1989) Susruta samhita (text with Hindi commentary) Nidana Arshonidana
2nd Chapter, Chi. 6th Chapter, VIIth Edition Chaukhamba Sanskrit Series Office, Varanasi.
273
It is safe and easily available method to prescribe medicines and patient’s acceptability is
good. Bheshaja chikitsa can however be mixed with other techniques or therapeutic measures.
Piles (haemorrhoids – internal haemorrhoids arise in the upper Anal Canal and lower rectum form
the internal various haemorrhoidal plexus. They enlarge to involve the skin-lined lower Anal Canal
and the external haemorrhoidal venous plexus to become visible externally.
Bright red bleeding is common as is prolapse of the piles on defecation, discomfort,
mucuous discharge and partial incontinence. The patient is investigated by proctoscopy and tehn
by sigmoidoscopy to ensure that no other lesion is responsible for the bleeding. Symptomatic piles
are treated on an out patient basis by injection of sclerosant or by rubber band ligation.
Haemorroide ctomy is reserved for more severe cases.
II. OBJECTIVE
Bhesaja, Ksarakarma, Raktavasecana, Agnikarma and Sastrakarma are the measure
adopted to treat Arsha Roga (Haemorrhoids) as described in Ayurvedic texts. The present study
is aimed at reducing the effect of some Ayurvedic medicines oral and local upon Gudarsh (Piles)
in various groups for comparison. The therapy so planned is non-invasive and may give relief to
a patient while keeping him active (at O.P.D. levels).
III. CENTRES:
Identified centres of CCRAS,New Delhi .
IV. SAMPLE SIZE AND METHODS:
Sample Size : 90 patients (30 patients in each group)
Trial Drug/Dosage/Duration
Group I : Kankayan Vati : 500 mg thrice a day
Triphala Churna : 5 gm at bed time
Kaseesadi Taila : 2 ml locally before defecation
Group II : Kravyadi Rasa : 500 mg thrice a day
Triphala Churna : 5 gm at bed time
Kaseesadi Taila : 2 ml locally before defecation
Group III : Kankayan Vati : 500 mg thrice a day
Kravyadi Rasa : 500 mg thrice a day along with
Abhayarishta : 15 ml thrice a day
Kaseesadi Taila : 2 ml locally before defecation
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Diet
Normal diet
Design of the study – Single blind open trial.
Duration of the Study - 21 days drug therapy with a follow up for every 15 days upto 3
months
V. CRITERIA FOR INCLUSION
1) Age > 5 years
2) Sex-either-sex
3) Fresh/previously operated
4) Painful/painless
5) Bleeds/does not bleed
6) Ano-rectal Arsha only/pertaining to Ano-rectal
7) Pile mass palpated/seen by P/R exam or proctoscopy
VI. CRITERIA OF EXCLUSION
1) Patients with malignancy
2) Incontinence of stool
3) Corrhosis liver-portal hypertension
4) Tuberculosis/Diabetes/Systemic disease
5) Bleeding diathesis
6) Multiple haemorrhoids/externo-internal haemorrhoids
VII. CRITERIA FOR WITHDRAWAL
(i) Discontinuation of treatment during trial
(ii) Development of any complication
(iii) Aggravation of the disease symptoms
(iv) Any side effect of the drug
VIII. ROUTINE EXAMINATION AND ASSESSMENT
The full details of screening, history and physical examination of the subjects will be
recorded as per case report form I & II. Clinical and physiological assessment in form III and
275
laboratory investigations i.e. Urine Routine & Microscopic, Stool Routine & Microscopic, TLC,
DLC, ESR, Hb%, B.T., C.T., P.T., Blood Sugar Fasting &PP, Proctoscopy, Sigmoidoscopy will
be done.
IX. CRITERIA FOR ASSESSMENT
Assessment will be done as per proforma after three months of regular treatment. However
the patients are to be reviewed after every 15 days.
Good Response
Complete disappearance of known symptomatology in absence of any other complication
with considerable regression in the size of pile mass.
Fair response
50% and above relief in presenting symptomatology of the disease with no/negligible
change in the size of pile mass.
X. TRIAL MONITORING AND STATISTICAL DATA ANALYSIS
Progress of the study can be mentioned by the clinicians by P/R exam or proctoscopy.
Improvement in symptoms can also be assessed and the data analyzed statistically.
XI. ETHICAL REVIEW:
Institutional Ethical Committee (IEC): The proposal will be placed before Institutional
Ethical Committee (IEC) of trial center for getting clearance certificate before the project is
initiated. Patient’s information sheet and informed consent form will be submitted along with project
proposal for approval by IEC.
XII. TRAVELING EXPENSES FOR RESEARCH SUBJECTS
A consolidated amount of Rs.…… /- per visit.
XIII. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
Short-term training will be provided to the Investigators and Laboratory personnel
involved in the multi-centric trial at CCRAS Hqrs., New Delhi. The investigators and technicians
will be detailed about the clinical trial conduct and laboratory procedures in order to maintain the
uniformity.
XIV. LABORATORY INVESTIGATIONS
The Laboratory Investigations (Pathological/Biochemical, etc.), which are not available at
research Institutes should be conducted at identified reputed labs /Government Institutes under
intimation to this Council following Codal formalities.
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
WRITTEN INFORMED CONSENT FORM
CERTIFICATE BY INVESTIGATOR
I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature of the Investigator ___________
Name: ____________________________
CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending physician, the purpose of the
clinical trial and the nature of drug treatment and follow-up, including the laboratory investigations
to be performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so. I am willing to undergo any risk for inclusion in
this study.
I, exercising my free power of choice, hereby give my consent to be included as a subject
in the clinical trial on “Comparative Clinical Evaluation of select Ayurvedic Treatment
Modalities in the Management of Arsha”.
Relationship ___________________________________
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
COMPARATIVE CLINICAL EVALUATION OF SELECT AYURVEDIC
TREATMENT MODALITIES IN THE MANAGEMENT OF ARSHA
PATIENT INFORMATION SHEET
278
What will you have to do?
Your doctor will explain clearly what you have to do. It is important that you follow the
instructions scrupulously. The study will take approximately 90 days. During treatment period,
you are expected to visit the hospital six times i.e. on 15th, 30th, 45th, 60th, 75th and 90th day for
clinical and physiological assessment.
Before you start treatment, during the first visit to the clinic, you will undergo a
complete physical examination, required objective tests and laboratory investigations will
also be done.
If you are found eligible, you would be put on trial treatment for 90 days.
At each visit, you will be supplied with sufficient quantities of drugs to last until
your next visit. If any adverse reactions like skin allergy, nausea, vomiting and
palpitation/tremor etc., noticed during the treatment period, this should be noticed to the
Principle Investigator.
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
COMPARATIVE CLINICAL EVALUATION OF SELECT AYURVEDIC
TREATMENT MODALITIES IN THE MANAGEMENT OF ARSHA
CASE REPORT FORM I – SCREENING
. Address: ..............................................................................................................................
..............................................................................................................................
2. Centre
Third Fourth
9. Painful/Painless
280
16. Multiple haemorrhoids/externo internal haemorrhoids
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
COMPARATIVE CLINICAL EVALUATION OF SELECT AYURVEDIC
TREATMENT MODALITIES IN THE MANAGEMENT OF ARSHA
CASE REPORT FORM II – HISTORY
2. Address: ..............................................................................................................................
4. Centre
Third Fourth
Parsi Others
282
13. Marital status Married Unmarried Divorcee/
separated
14. Pain
15. Swelling
16. Tenderness
17. Itching
18. Indurations
After defecation
26. Hypertension
28. Piles
283
29. Tuberculosis
30. Others
If yes specify………….......………………………….…………………………………….
31. Smoking
32. Obesity
33. Non-vegetarian
34. Alcoholic
Sannipataj
Sama
PHYSICAL EXAMINATION
284
43. Blood pressure (Diastolic)
44. Pulse
45. Respiration
SYSTEMIC EXAMINATION
48. Hepatomegaly
49. Sleenomegaly
50. Tumour/Lump
Shukra
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
COMPARATIVE CLINICAL EVALUATION OF SELECT AYURVEDIC
TREATMENT MODALITIES IN THE MANAGEMENT OF ARSHA
CASE REPORT FORM III -PERIODICAL OBSERVATION AND CLINICAL
ASSESSMENT
(On Day 0, 15 days, 30 days, 45 days, 60 days, 70 days and 90 days)
Separate form should be used on each visit
(Enter a in the appropriate box)
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
COMPARATIVE CLINICAL EVALUATION OF SELECT AYURVEDIC
TREATMENT MODALITIES IN THE MANAGEMENT OF ARSHA
CASE REPORT FORM IV- LABORATORY ASSESSMENT
2. Centre________________________________
6. Urine Examination
Routine Microscopic
7. Stool examination
Routine Microscopic
Blood
9. DLC - P _____ (%) L _____ (%) E ______ (%) M _____ (%) B ______(%)
12. S. Bilirubin
• Total (mg/dl)
• Direct (mg/dl)
287
13. SGPT (IU/L)
• Albumin (g/dl)
• Globulin (g/dl)
• Fasting
• Post prondial
20. S. Cholesterol
Special Tests
(i) Proctoscopy
(ii) Sigmoidoscopy
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
COMPARATIVE CLINICAL EVALUATION OF SELECT AYURVEDIC
TREATMENT MODALITIES IN THE MANAGEMENT OF ARSHA
CASE REPORT FORM I – SCREENING OF THE CASES
2. Centre
4. Group No.
CLINICAL PARAMETERS
Pain
Swelling
Tenderness
Itching
Indurations
Bleeding
LAB INVESTIGATIONS
Note: Severity of the symptoms may be graded as I, II and III grades as per positively in
increasing order (mild 1, moderate 2 and severe 3)
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290
COMPARATIVE CLINICAL EVALUATION OF
KSHARASUTRA VIS-À-VIS APPLICATION OF KSHARA
VATI IN THE MANAGEMENT OF BHAGANDARA
(FISTULA-IN-ANO)
291
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292
COMPARATIVE CLINICAL EVALUATION OF KSHARASUTRA VIS-À-VIS
APPLICATION OF KSHARA VATI IN THE MANAGEMENT OF
BHAGANDARA (FISTULA-IN-ANO)
I. BACKGROUND
Bhagandara1 (Fistula in ano), Arsha (haemorrhoids) and Gudavidara (Parikartika) are some
ano rectal torturesome diseases. Among these, Bhagandara is one of the most painful diseases. It
is a disease of ano rectum which is characterized in humans by single or multiple sinuses with
purulent discharge. It is an obnoxious condition.
This is a field where modern surgery could not help much as extensive excision of the
fistulous tract result into a wide open wound with slow healing rate. Chances of wound infection,
non-healing and recurrences are high. Application of Ksharasutra in the management of fistula-in-
ano showed encouraging results (Deshpande et al 1989). The patients can abstain from
psychological trauma and extensive surgery.
Patients can undergo treatment without paralyzing their routine work.
Kshara Vati is also found to help in such cases. Thus it is important to evaluate the result
after a comparative study.
II. AIMS AND OBJECTIVE
Medical management of diseases in Ayurveda is quite popular. However, there are diseases
which can be treated by para-surgical methods in better way. Management of Bhagandara by
Ksharasutra is one such example. Thus the present study is proposed with a view to:
1. Study the disease pattern of Bhagandara (Fistula in ano)
2. To evaluate the effect of Ksharasutra application in the management of Bhagandara
(Fistula in ano)
3. To compare it with the effect of Kshara Vati (applied 7 times in 21 days) in the
management of Bhagandara (Fistula in ano)
References
1. Sushruta Nindan 4th cheptar.
293
III. SAMPLE SIZE AND METHODS
Sample Size : 60 cases
No of Groups : 2 (30 patients in each group) (Patients to be randomly
allocated to different treatment groups)
Type of Study : Single blind
Level of Study : O.P.D.
Period of Study : 21 days in Kshara Vati
In Ksharasutra group according to disease
Dose Schedule
(i) Ksharasutra application depends upon the severity and depth of fistula.
(ii) Kshara Vati will be applied seven times at the interval of every two days.
Note: Renewal of Ksharasutra will be decided by the research workers looking
after the problem.
Diet
Normal diet
IV. CRITERIA OF INCLUSION
1) Age preferably above 8 to 10 years
2) Sex-either-sex
3) Fresh/previously operated
4) Painful/painless
5) Discharging/non-discharging
6) Purulent/non-purulent
7) Tender/non-tender
8) All cases of fistula in ano
V. CRITERIA OF EXCLUSION
1) Patients with malignancy
2) Incontinence of stool/stricture of anus
3) Tuberculosis/Diabetes/Systemic disease/infections
294
4) Bleeding diathesis
5) Fistula connected with other organs like urethra vagina etc.
VI. CRITERIA FOR ASSESSMENT
Assessment will be done as per proforma after 21 days of regular treatment in group
treated with Kshara Vati. However in case of Ksharasutra application it depends upon the disease
and physicians perception.
VII. CRITERIA FOR ASSESSMENT OF RESULTS
1. Good Response:
Complete disappearance of known symptomatology
• absence of any other complication
• Normal healing of the wound
2. Fair response:
50% and above relief in presenting symptomatology of the disease
• Absence of complications
• Healing of the wound more than 75%
3. Poor response:
25% to 50% relief in symptomatology + some improvement in the wound
4. No response
No relief in symptomatology or otherwise
VIII. CRITERIA FOR WITHDRAWAL
(i) Discontinuation of treatment during trial
(ii) Development of any complication
(iii) Aggravation of the disease symptoms
(iv) Any toxicity/local reaction of Sutra/Vati
IX. STATISTICAL ANALYSIS
Data of clinical symptoms, physiological parameters and laboratory parameters will be
tabulated and analyzed by using appropriate statistical methods. The data of each case will have
to be communicated on completion of trial therapy to the Statistical Officer of CCRAS through e-
mail for analysis
295
X. TRIAL MONITORING AND DATA ANALYSES
The progress of the trial will be monitored through field visits by monitoring unit of
CCRAS. Data analysis will be undertaken at the Monitoring Unit of CCRAS.
XI. ETHICAL REVIEW:
Ethical Committee (IEC): The proposal will be placed before Ethical Committee
(IEC) of trial center for getting clearance certificate before the project is initiated.
Patient’s information sheet and informed consent form will be submitted along with
project proposal for approval by EC. Both will be maintained in duplicate with one copy
given to the patient at the time of entry to the trial.
XII. TRAVELING EXPENSES FOR RESEARCH SUBJECTS
A consolidated amount of Rs.……. /- per visit i.e., on the 1st day of recruitment after
screening and at the end of 7th, 14th, 21st and 30th day of months. (5 times)
XIII. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
Short-term two-day training will be provided to the Investigators and Laboratory
personnel involved in the multi-centric trial at CCRAS Hqrs., New Delhi. The investigators and
technicians will be detailed about the clinical trial conduct and laboratory procedures in order to
maintain the uniformity.
XIV. LABORATORY INVESTIGATIONS
Microscopic
Urine
Routine
Microscopic
Stool Cyst
Routine
Ova
Stool: - For Occult Blood
Sputum: - A.F.B. (To exclude Koch’s if required)
296
Fasting
Blood Sugar
PP
297
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
COMPARATIVE CLINICAL EVALUATION OF KSHARASUTRA VIS-À-VIS
APPLICATION OF KSHARA VATI IN THE MANAGEMENT OF
BHAGANDARA (FISTULA-IN-ANO)
WRITTEN INFORMED CONSENT FORM
CERTIFICATE BY INVESTIGATOR
I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature of the Investigator ___________
Name: ____________________________
CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending physician, the purpose of the
clinical trial and the nature of drug treatment and follow-up, including the laboratory investigations
to be performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so. I am willing to undergo any risk for inclusion in
this study.
I, exercising my free power of choice, hereby give my consent to be included as a subject
in the clinical trial on “Comparative clinical evaluation of ksharasutra vis-à-vis application
of kshara vati in the management of bhagandara (fistula-in-ano)”.
298
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
COMPARATIVE CLINICAL EVALUATION OF KSHARASUTRA VIS-À-VIS
APPLICATION OF KSHARA VATI IN THE MANAGEMENT OF
BHAGANDARA (FISTULA-IN-ANO)
PATIENT INFORMATION SHEET
299
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CASE REPORT FORM I – SCREENING
2. Address: ..............................................................................................................................
3. Centre
Third Fourth
2. Either sex
3. Fresh/Previously operated
4. Painful/Painless
5. Discharging/Non-discharging
6. Purulent/Non-purulent
7. Tender/Non-tender
300
13. Fistula connected with other organs like Urethra vagina etc.
301
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
COMPARATIVE CLINICAL EVALUATION OF KSHARASUTRA VIS-À-VIS
APPLICATION OF KSHARA VATI IN THE MANAGEMENT OF
BHAGANDARA (FISTULA IN ANO)
CASE REPORT FORM II – HISTORY
2. Address: ..............................................................................................................................
4. Centre
Third Fourth
Parsi Others
302
11. Marital status Married Unmarried Divorcee/
separated
12. Pain
13. Burning
14. Swelling
15. Tenderness
16. Itching
17. Indurations
......…………………………………………………………………………………………
..……………………………………………………………………………………………
Yes No
If yes, specify…………………………………………………………………………
303
25. Excision
28. Hypertension
31. Tuberculosis
32. Others
If yes specify…………………………….......……….…………………………………….
Sannipataj
Sama
PHYSICAL EXAMINATION
304
36. Body weight (in Kg.)
39. Pulse
40. Respiration
Present Absent
41. Anaemia
42. Jaundice
43. Lymphadenopathy
SYSTEMIC EXAMINATION
Normal Abnormal
45. C.N.S
305
SAMPRAPTI (PATHO GENESIS) OF THE DISEASE ACCORDING AYURVEDIC
CONCEPT
Shukra
LOCAL EXAMINATION
52. Inspection
Normal
Inflamed
Indurated
External piles/tags
Discolouration of skin
2). Opening
Fissure Yes No
Hypertonic
306
Hypotonic
(i) Blood (ii) Pus (iii) Faecal material (iv) Urine (v) Gas
5). Probing
Character of Fistula
1. Presence of pile
2. Inflammation
7). Sigmoidoscopy
If done then………………………………………………………………………….
Yes No
A. Ulceration
B. Bleeding
C. Mucous
307
8). Biopsy
CLASSIFICATION OF FISTULA
1. Low cutaneous
2. Sub. Mucous
3. Low anal
4. High anal
5. Ano rectal
6. Pelvi rectal
1. Shataponak (Vataja)
2. Ushragreeva (Pittaja)
3. Parisravi (Kaphaja)
4. Shambukartava (Sannipataja)
5. Unmargi (Agantuja)
Provisional Diagnosis
Final Diagnosis
308
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
COMPARATIVE CLINICAL EVALUATION OF KSHARASUTRA VIS-À-VIS
APPLICATION OF KSHARA VATI IN THE MANAGEMENT OF
BHAGANDARA (FISTULA IN ANO)
CASE REPORT FORM III – CLINICAL ASSESSMENT
1. Centre………………………………………………………………………………………
2. Code No. (of clinical trial)
3. Patient No.
4. Group No.
INITIAL Days after starting therapy
5. Pus-discharge
6. Induration
7. Inflammation
8. Pain
9. Burning sensation/itching
10. Bleeding
309
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
COMPARATIVE CLINICAL EVALUATION OF KSHARASUTRA VIS-À-VIS
APPLICATION OF KSHARA VATI IN THE MANAGEMENT OF
BHAGANDARA (FISTULA IN ANO)
CASE REPORT FORM IV– INVESTIGATION
1. Centre………………………………………………………………………………………
2. Code No. (of clinical trial)
3. Patient No.
4. Group No.
Investigation Time of after 7 days after 14 days after 21days after month
Admission
Microscopic
5. Urine
Routine
6. Urine Glucose
Microscopic
7. Stool Cyst
Routine
Ova
310
10. Biochemistry
Fasting
11. Blood Sugar
PP
311
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312
NERVOUS SYSTEM
SECTION - V
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314
DOUBLE BLIND CLINICAL TRIAL OF AYURVEDIC
TREATMENT IN THE MANAGEMENT OF
PAKSHAGHATA
315
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
DOUBLE BLIND CLINICAL TRIAL OF AYURVEDIC TREATMENT IN THE
MANAGEMENT OF PAKSHAGHATA
I. BACKGROUND
Paksaghata (hemiplegia) is a major disabling disease of mankind. The terms Paksaghata,
Parsavadha and Ekangaroga are synonyms of the same disease and are used in classical
treatises in various contexts. Caraka has classified it as Nanatmaja vata vyadhi caused due to
vitiation of Vata dosa and considered it as a Maharoga from the point of prognosis – difficult to
cure. According to the concept, the disease affects the Madhyama roga marga and disrupting the
functions of Sira, Snayu, Kandara etc. According to modern terminology, hemiplegia is the
sequelae of pathological events which take place in the central nervous system, may be due to
different factors such as cerebro-vascular accidents neoplasm, infections etc. where in paralysis
will be common symptom. Ayurveda has a definite pattern of treatment for such conditions. The
line of treatment includes Snehana, Svedana and Panchakarma therapy. The Snehana and
Svedana therapy mentioned in the classics are used as preparatory mearues for Sodhana therapy.
(Caraka Samhita Chikitsa 28-100, Susrut Chikitsa 5-19). This Council has taken up this
problem for research and different methods of therapy used in clinical practice are taken up for
intensive evaluation of their efficacy of samana therapy alongwith Panchakarma therapy. A series
of clinical studies to evaluate the effect of herbo-mineral preparation and application of Sastikasali
pindasveda with Brihat Masa Taila alongwith Panchakarma therapy has shown that these
therapies are giving significant results and found effective in relieving hypertenic (stiffness) of
muscles and to improve the functional ability of the affected limb (P.K.N. Namboodiri et al,
2000, Management of Hemiplegia by Panchakarma & Samana therapy CCRAS). The objective
of present study is to evaluate the effect of samana &panchakarma therapies with and without
internal medication in the management of Paksaghata1.
II. OBJECTIVES
To assess the efficacy of Ayurvedic treatment in the management of Pakshaghata.
References
1. Charak Chikitsa 28 Ch. (Vata Vyadhi Chikitsa)
317
III. CENTRE
CCRAS identified Centers.
IV. SAMPLE SIZE AND METHODS
Sample Size : 100 patients (50 in each in group, two groups)
Treatment
A. Sodhan Chikitsa
1. Snehapana - Murchita tila taila (maximum 7 days)
2. Svedana - Vaspa Sveda (3 days)
3. Virecana - Eranda Taila (1 day)
4. Samsarjana - 7 days
5. Abhyanga - Brihat masa Taila (7 days)
6. Yogabasti (8 days) (a) Anuvasana – Morchitataila (240ml) [1st, 3rd, 5th,
7th, 8th] (Oil Enema –Dose 240ml)
(b) Asthapana – [2nd, 4th, 6th]
(Decoction Enema – Dose 960ml)
Erandamula Kvatha (480 ml.)
Morchitataila (240ml)
Honey – 180 ml
Satahva – 24 gm
Saindhava – 12 gm
** One Day Rest
7. Nasya Kshirabala taila - 3 times (Potency) (7 days)
** One Day Rest
B. Samana therapy
Internal _ Ekangavirarasa (250 mg twice daily)/ Placebo (250 mg.) BD.
Externally – 1. Morchitataila (50ml) (Abhayanga)
2. Sastikasali pinda Sveda – 14 days
318
Design of Study: Randomized double blind placebo controlled study.
1. All the patients will be provided with the Sodhana therapy for 35 days.
2. After completion of Sodhana therapy patients will be devided into two groups. One group
will receive trial drug in the dose of 250 mg. twice daily for 30 days along with
Abhyanga for 30 days and Sastikasasli pinda sveda for 14 days. The other group will
receive placebo in the dose of 250 mg. twice daily for 30 days along with Abhyanga for
30 days and Sastikasasli pinda sveda – for 14 days. Oral drug as well as Abhyanga
and Sastikasasli pinda sveda will run simultaneously.
Period of Study: Six months of each case. Total duration will be two and half years to complete
the study.
Follow Up: One follow up will be carried out at the end of 6th month.
V. CRITERIA FOR INCLUSION
1. Age: More than 20 years and less than 70 years.
2. Duration of illness more than 6 months but less one year.
3. Patients of stable one time stroke with hemiparesis or hemiplegia with or without facial
paralysis.
4. Patients with non-progressive neurological disease causing Para paresis (plegia) such as
- Compressive mydopathy (operated)
- Non-compressive (post-viral, denyclinating, post traumatic, vascular)
5. Motor deficit should be 3/5 or less (MRC Grade).
6. Spasticity of a scale of 3 or more (Ashwarth Scale)
7. Medically stable
8. Fully conscious and oriented
9. Normal Higher mental functions
VI. CRITERIA FOR EXCLUSION
1. Age less 20 and more than 70 years.
2. Progressive Neurological diseases.
3. Pregnancy & lactation.
4. Insulin dependent diabetis mellitus (IDDM)
319
5. Impaired sensorium
6. Recurrent strokes.
7. History of Renal and liver diseases
8. Cases undergoing treatment for any other serious illness.
VII. CRITERIA FOR WITHDRAWAL
A patient may be withdrawn from the study on account of the following.
1. Recurrent attacks of strokes.
2. Development of any major ailments, side effects necessitating institution of new modalities
of treatment.
3. Worsening of symptoms.
4. Patient failure to report for follow-up or irregular medication.
VIII. ROUTINE EXAMINATION AND ASSESSMENT
The full details of history and physical examination of the patients will be recorded as per
the proforma (Forms I & II). Clinical assessment will be done before the therapy, at the end of
5th week, end of 9th week, end of 6th month (Form III). The lab investigations will be recorded
before therapy, end of 5th week, end of 9th week and at the end of follow up (6th month)
(Form IV).
IX. CLINICAL ASSESSMENT:
MOTOR PARALYSIS
a). Clinical muscle strength testing – MRC Grading:
0. - Nil
1. - Flicker of movement.
2. - Movement with gravity eliminated.
3. - Movement against gravity.
4. - Movement against minimal resistance
5. - Movement against maximum resistance.
b). ADL (Activities of Daily Living) Score
c). Dynamometers – for measuring isometric strength.
320
Spasticity:
A. Clinical
a. -Ashworth Scale Score:
0. - No increase in tone
1. - Slight increase producing a catch when a joint is moved in flexion or extension.
2. - More marked increase in tone, but joint easily flexed
3. - Considerable increase and passive movements difficult.
4. - Affected part rigid in flexion or extension.
b. -Spasm Score:
0. - No spasms
1. - Mild spasms induced by stimulus
2. - Spasms occurring less than 1 per hour
3. - Spasms occurring more than 1 per hour
4. - Spasms occurring more than 10 per hour
c. - Reflex Score:
0 - Absent
1 - Flicker/elicitable only on reinforcement
2 - Diminished knee/normal other DTR (deep tendon reflexes)
3 - Normal knee/hyperreflexia of other DTR
4 - Clonus – illsustained
5 - Sustained clonus
B. Biomechanical Techniques:
Biomechanical techniques evaluate changes in the phasic and tonic reflex activity of the
muscles across a joint.
- Wartenberg’s pendulum or the “drop” test.
- With an electrogoniometer to record the changes in the knee joint angle.
- Relaxation index.
321
X. STATISTICAL ANALYSIS
Clinical symptoms and laboratory parameters will be analyzed using appropriate statistical
methods.
XI. TRIAL MONITORING AND DATA ANALYSIS
The progress of the trail will be monitored by field visits by Monitoring unit of CCRAS.
Data analysis will be undertaken at the Monitoring Unit of CCRAS
XII. ETHICAL REVIEW
A. Ethical Committee (IEC): The proposal will be placed before Ethical Committee (IEC)
of trial center for getting clearance certificate before the project is initiated. Patient’s
information sheet and informed consent form will be submitted along with project proposal
for approval by EC. Both will be maintained in duplicate with one copy given to the
patient at the time of entry to the trial.
B. Data and Safety Monitoring Board: A Data and safety monitoring board (DSMB) at
Hqrs. will carefully monitor the data and side effects during the period of study and put in
a place where by prompt reporting of adverse events occur. The data will be reviewed as
every 20 participants entered the study and administered the trial drugs. The research team
will report immediately to the PI and Data Monitoring Board if, any life threatening
conditions whether they are perceived to be study related or not. The Board decides
whether the adverse effects warrant discontinuation of the study protocol. Protocols will be
written and approved for the treatment of study related adverse events.
XIII. TRAVELLING EXPENSES
A consolidated amount of Rs……../- per visit will be paid to the subject.
XIV. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
Short-term two-day training will be provided to the Investigators and Laboratory
personnel involved in the multicentric trial at CCRAS Hqrs. and Central Research Institute (Ay.),
New Delhi. The investigators and technicians will be detailed about the clinical trial conduct and
laboratory procedures in order to maintain the uniformity.
XV. LABORATORY INVESTIGATIONS
The Laboratory Investigations (Pathological / Biochemical, Radiological / Sonography etc.)
which are not available at research Institutes will be referred to any reputed/Government Institutes
under intimation to this Council following codal formalities.
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
DOUBLE BLIND CLINICAL TRIAL OF AYURVEDIC TREATMENT IN THE
MANAGEMENT OF PAKSHAGHAT
WRITTEN INFORMED CONSENT FORM
CERTIFICATE BY INVESTIGATOR
I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature of the subject: ______________
Name: ____________________________
CONSENT BY SUBJECT
The attending physician, the purpose of the clinical trial and the nature of drug treatment
and follow-up have informed me to my satisfaction, including the laboratory investigations to be
performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so. I am willing to undergo any risk for inclusion in
this study.
I, exercising my free power of choice, hereby give my consent to be included as a subject
in the, “Double blind clinical trial of Ayurvedic treatment in the management of pakshaghat”.
Relationship ___________________________________
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
DOUBLE BLIND CLINICAL TRIAL OF AYURVEDIC TREATMENT IN THE
MANAGEMENT OF PAKSHAGHAT
PATIENT INFORMATION SHEET
324
Before you start treatment, during the first visit to the clinic, you will undergo a
complete physical examination, required objective tests and laboratory investigations will
also be done. If you are found eligible, you would be put on treatment for 1 month.
At each visit, you will be supplied with sufficient quantities of drugs to last until
your next visit. If any adverse reactions like skin allergy, nausea, vomiting and
palpitation/tremor etc., noticed during the treatment period, this should be noticed to the
325
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
DOUBLE BLIND CLINICAL TRIAL OF AYURVEDIC TREATMENT IN THE
MANAGEMENT OF PAKSHAGHATA (HEMIPLEGIA)
CASE REPORT FORM I – SCREENING
BEFORE TREATMENT
(Enter a in the appropriate box)
1. Centre: ………………..……….
6. Address ……………………………………..…………..........……………………………
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10. Progressive Neurological diseases
12. IDDM
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
DOUBLE BLIND CLINICAL TRIAL OF AYURVEDIC TREATMENT IN THE
MANAGEMENT OF PAKSHAGHATA (HEMIPLEGIA)
CASE REPORT FORM II – HISTORY PROFORMA
1. Centre : ........................................
5. Address: ..............................................................................................................................
328
13. Difficulty for locomotion
14. Rigidity
15. Flacidity
16. Spasm
17. Numbness
Personal History
Addiction
329
30. Alcohol No 1 Yes 2
33. Hypertention
Sannipataja 7
330
Systemic examination Normal (0) Abnormal (1)
47. CNS
If abnormal details_____________________________________________
49. CVS
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
DOUBLE BLIND CLINICAL TRIAL OF AYURVEDIC TREATMENT IN THE
MANAGEMENT OF PAKSHAGHATA (HEMIPLEGIA)
CASE REPORT FORM III – CLINICAL ASSESSMENT
(0th, 5th, 9th Weeks and 6th Month)
1. Centre : ........................................
5. Address: ..............................................................................................................................
7. Date of Assessment
332
OBJECTIVE PARAMETERS
MOTOR PARALYSIS
0. - Nil
1. - Flicker of movement.
20. Spasticity
CLINICAL PARAMETERS
0 - No increase in tone
0 - No spasms
333
23. Reflex Score:
0 - Absent
1 - Flicker/elicitable only on reinforcement
2 - Diminished knee/normal other DTR (deep tendon reflexes)
3 - Normal knee/hyperreflexia of other DTR
4 - Clonus – illsustained
5 - Sustained clonus
BIOMECHANICAL TECHNIQUES
(Biomechanical techniques evaluate changes in the phasic and tonic reflex activity of the muscles
across a joint.)
25. With an electrogoniometer to record the changes in the knee joint angle.
Deteriorated 4
Continuing 1
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
DOUBLE BLIND CLINICAL TRIAL OF AYURVEDIC TREATMENT IN THE
MANAGEMENT OF PAKSHAGHATA (HEMIPLEGIA)
CASE REPORT FORM IV – LABORATORY INVESTIGATIONS
(0th, 5th, 9th week and 6th month)
1. Centre : ........................................
5. Address: ..............................................................................................................................
7. Date of Assessment
Urine Examination
A. Routine:
9. pH _______
11. Sugar
12. Albumin
335
B. Microscopic ______________________________
Blood Examination
336
Serum Electrolytes
36. K+ _______________________
337
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338
ASSESSMENT OF THERAPEUTIC EFFICACY OF
AYUSH-M NASAL DROPS AND AYUSH-M CAPSULE IN
THE MANAGEMENT OF MIGRAINE WITH OUT
AURA (ARDHAVA BHEDAKA)
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF THERAPEUTIC EFFICACY OF AYUSH-M NASAL DROPS
AND AYUSH-M CAPSULE IN THE MANAGEMENT OF MIGRAINE WITH
OUT AURA (ARDHAVA BHEDAKA)
I. BACKGROUND
Migraine1 (Ardhava Bhedaka) is as old as civilization, occupying 16% among clinical
classification of headaches, has become a challenging problem to the present day physician1&2. It
is a paroxysmal disorder characterized in its fully developed form by visual and/or sensory
phenomena in an aura associated with or followed by unilateral headache and vomiting. While this
definition is satisfactory of ‘Classical’ Migraine, there are many patients who never experience an
aura and in whom the headache is always bilateral; the single most characteristic and constant
feature is that migraine is a paroxysmal disorder, i.e., the headaches occur in attacks, separated by
intervals of freedom. It is described as a separate clinical entity in the classics of Caraka and
Susruta while Vagbhata included this condition in the classification of Vatajashiroroga. A clinical
study conducted on 20 cases migraine to evaluate the effect of Nasya Karma with fresh leaf juice
extracted from Acalypha indica Linn. (Haritamanjari,) along with internal medication of
Panchagavya ghrta (Astanga Hradya, Uttara Tantra 7/18) revealed significant clinical
improvement.
II. OBJECTIVE
To evaluate the therapeutic efficacy of Ayush-M coded nasal drops and Ayush-M capsule
in the management of Migraine without aura.
References
1. Peter J Goadsby et al, Diagnosis and management of migraine, Selections from BMJ Vol.12 July,
1996 pp 456-460.
2. Classification Committee of the International Headache Society. Classification and diagnostic
criteria for headache disorders, cranial neuralgias and facial pain, Cephalagia 1988 (suppl.7): 1-
96.
3. Srikanth N. et al, Clinical study on the role of Nasyakarma and Ghritapana in the management
of Arddhavabhedaka vis-à-vis Migranous headaches, Aryavaidyan Vol.XIX, No.3, Fe-Apr.2001
: 166-171.
341
III. CENTRE
Central Research Institute (Ay.), New Delhi
IV. SAMPLE SIZE AND METHODS
Sample Size : 30 cases
Design of the study – Open trial
Treatment
a. Snehana: Local application of Til oil around nose followed by local mridu swedana(mild
fomentation) as poorva karma
b. Ayush-M Nasal drops {containing equal parts of Acalypha indica Linn. (Haritamanjari,)
and Glycyrrhiza glabra (Yasti madhu) – 3-drops in each nostril after poorva karma for
7 days.
c. Ayush-M (Glycyrrhiza glabra (Yasti madhu)- Two capsules (500 mg) twice a day with
water for two months
Duration of the study- Two months drug therapy with a follow up for one month without drug.
Period of Study: Three months for each case. Total duration will be one year to complete the
trial.
Follow – Up: One follow-up will be carried out after one month of the completion of
treatment.
V. CRITERIA FOR INCLUSION
1. Age between 20 years and 60 years
2. Both the sex
3. Patient with five or more attacks of Migraine(headache) without Aura lasting for 4-72
hours presenting with a) at least two of the features viz. i) unilateral, ii) Pulsating, iii)
Moderate to severe, iv) Aggravated by movement and b)at least one of the features viz.
i) Nausea, ii) Photophobia, iii) Phonophobia (Classification Committee of the International
Headache Society. Classification and diagnostic criteria for headache disorders, cranial
neuralgias and facial pain, Cephalagia 1988 (suppl.7): 1-96..}
VI. CRITERIA FOR EXCLUSION
1. Age below 20 and above 60 years
2. Less than five attacks of Migraine without Aura.
342
3. Clinically diagnosed cases of
a.. Tension headache
b. Cluster headache.
c. Idiopathic stabbing headache
d. Exertional headache.
e. Headache due to systemic infection.
f. Drug induced headache
4. Organic brain lesions
5. Systemic disorders
6. Person undergoing treatment for any other serious illness
VII. CRITERIA FOR WITHDRAWAL
During the course of the trial treatment, if any serious condition develops/ symptoms
aggravates, which requires urgent treatment, such subjects may be withdrawn from the trial and
managed by the Principal Investigator accordingly.
VIII. ROUTINE EXAMINATION AND ASSESSMENT
The full details of history and physical examination of the patients will be recorded as per
the Performa (Forms I & II). Clinical assessment will be done before drug administration, at the
end of 1st month, 2nd month during treatment and at the end of 3rd month during follow up (Form
III). Required laboratory investigations will be carried out to exclude cases as specified in the
criteria for exclusion. Form-IV)
IX. CRITERA FOR ASSESMENT OF RESULT OF TREATMENT
Disappearance of headache and presenting clinical features i.e. (i) Unilateral, (ii) Pulsating,
(iii) Moderate to severe nature, (iv) Aggravated by movement, (v) Nausea, (vi) Photophobia &
(vii) Phonophobia will be considered as significant improvement.
X. STATISTICAL ANALYSIS
Data on clinical symptoms, duration of attack and frequency of attack will be tabulated
and analysed using appropriate statistical tools.
XI. TRIAL MONITORING AND DATA ANALYSES
The progress of the trial will be monitored by CCRAS HQrs. New Delhi. Data analysis
will be undertaken at the Monitoring Unit CCRAS HQrs. New Delhi
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XIII. ETHICAL REVIEW
A. Institutional Ethical Committee (IEC): The proposal will be placed before Institutional
Ethical Committee (IEC) of trial center for getting clearance certificate before the project
is initiated. Patient’s information sheet and informed consent form will be submitted along
with project proposal for approval by IEC.
B. Data and safety monitoring board: A Data and safety monitoring board (DSMB) at Hqrs
will carefully monitor the data and side effects during the period of study and put in a
place where by prompt reporting of adverse events occur and take appropriate steps in
case of any adverse events occur. The data will be reviewed for every 20 participants
included into the study and administered the trial drugs. The research team will report
immediately to the PI and Data Monitoring Board 1) any life threatening conditions
whether they are perceived to be study related or not. The Board decides whether the
adverse effects warrant discontinuation of the study protocol. Protocols will be written and
approved for the treatment of study related adverse events
XII. TRAVELING EXPENSES FOR RESEARCH SUBJECTS
A consolidated amount of Rs……. /- per visit will be paid to subject selected for trial.
XIII. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
Short-term two-day training will be provided to the Investigators involved in the trial at
CCRAS Hqrs. New Delhi. The investigators will be detailed about the clinical trial conduct and
laboratory procedures in order to maintain the uniformity.
XIV. LABORATORY INVESTIGATIONS
The Laboratory Investigations (Hematological /Biochemical, etc.), which are not available
at research Institutes should be conducted at identified reputed labs /Government Institutes under
intimation to this Council following codal formalities.
344
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF THERAPEUTIC EFFICACY OF AYUSH-M NASAL DROPS
AND AYUSH-M CAPSULE IN THE MANAGEMENT OF MIGRAINE WITH
OUT AURA (ARDHAVA BEDHAKA)
CONSENT FORM
CERTIFICATE BY INVESTIGATOR
I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature of the Investigator ___________
Name: ____________________________
CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending physician, the purpose of the
clinical trial and the nature of drug treatment and follow-up, including the laboratory investigations
to be performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so.
I, exercising my free power of choice, hereby give my consent to be included as a subject
in the clinical trial on “Assessment of Therapeutic Efficacy of Ayush-M Nasal Drops and Ayush-
M capsule in the management of Migraine with out Aura (Ardhava Bhedaka )
345
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF THERAPEUTIC EFFICACY OF AYUSH-M NASAL DROPS
AND AYUSH-M CAPSULE IN THE MANAGEMENT OF MIGRAINE WITH
OUT AURA (ARDHAVA BEDHAKA)
PATIENT INFORMATION SHEET
346
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF THERAPEUTIC EFFICACY OF AYUSH-M NASAL DROPS
AND AYUSH-M CAPSULE IN THE MANAGEMENT OF MIGRAINE WITH
OUT AURA (ARDHAVA BEDHAKA)
CASE REPORT FORM I - SCREENING
1. Centre: ………………..……….
6. Address ……………………………………..…………..........……………………………
i) unilateral,
ii) Pulsating,
i) Nausea,
ii) Photophobia,
347
iii) Photophobia
8. Tension headache
9. Cluster headache
348
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF THERAPEUTIC EFFICACY OF AYUSH-M NASAL DROPS
AND AYUSH-M CAPSULE IN THE MANAGEMENT OF MIGRAINE WITH
OUT AURA (ARDHAVA BEDHAKA)
CASE RFPORT FORM II - HISTORY
1. Centre : ........................................
6. Address: ..............................................................................................................................
349
Chief complaints with duration Present (1) Absent (0)
15. Pulsating,
18. Nausea
19. Photophobia,
20. Phonophobia
Less than five hours five to ten hours more than 10 hours
Personal History
(a) Initiation:
(b) Maintenance:
350
25. Anxiety
26. Constipation
Addiction
31. Prakriti:
Sannipataj 7
351
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF THERAPEUTIC EFFICACY OF AYUSH-M NASAL DROPS
AND AYUSH-M CAPSULE IN THE MANAGEMENT OF MIGRAINE WITH
OUT AURA (ARDHAVA BEDHAKA)
CASE REPORT FORM III - CLINICAL ASSESSMENT
[0, end of the Ist Month, IInd Month, IIIrd Month]
1. Centre : ........................................
6. Address: ..............................................................................................................................
8. Date of Assessment
9. Unilateral headache
11. Nausea
12. Photophobia
13. Phonophobia
Less than five hours five to ten hours more than ten hours
352
16. Adverse reaction: Yes 1 No 2
If yes, details:_______________________
Continuing 1
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF THERAPEUTIC EFFICACY OF AYUSH-M NASAL DROPS
AND AYUSH-M CAPSULE IN THE MANAGEMENT OF MIGRAINE WITH
OUT AURA (ARDHAVA BEDHAKA)
CASE REPORT FORM IV – LABORATORY INVESTIGATIONS
(BEFORE TREATMENT)
1. Centre : ........................................
2. Code No. (of clinical trial)
3. Sr. No. of the Subject : _______________________
4. Name of the patient .............................................................................................................
5. Gender: Male 1 Female 2
6. Address: ..............................................................................................................................
7. Date of Birth Age (in years)
8. Date of Assessment
9. Urine Examination: Routine____________ / Microscopic___________
10. TC (Cells/Cmm.)_____________________
11. DC: P (%)______ L (%)______ E (%)______ M (%)______B (%)______
12. Hb (g/dl) ______________
13. ESR (1st hour.)(mm) ______________
14. Blood Sugar – PP (mg./dl)______________
15. B. Urea (mg./dl) ______________
16. S. Creatinine (mg./dl) _______________
17. Uric acid (mg./dl) _______________
18. Lipid profile ______________
19. Liver function tests ______________
354
DOUBLE BLIND PLACEBO CONTROLLED
CLINICAL EVALUATION OF “AYURVEDIC CODED
DRUG (AYUSH MANAS)” IN THE MANAGEMENT OF
“MANASA MANDATA (MENTAL RETARDATION)”
355
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356
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
DOUBLE BLIND PLACEBO CONTROLLED CLINICAL EVALUATION OF
“AYURVEDIC CODED DRUG (AYUSH MANAS)” IN THE MANAGEMENT OF
“MANASA MANDATA (MENTAL RETARDATION)”
I. BACKGROUND
Manasa mandata is a condition in which the normal growth of the child is affected and
this could be equated with mental retardation due to various reasons. According to Ayurveda this
deficiency occurs due to beeja dosha where the parents of the child might have had incompatible
and improper diet and habits, during and before their conjugation. According to ayurvedic
concepts vata or vayu (bodily bioforce) is the self-generating and self-propagating energy, which
is responsible for the conduct, regulation and integration of all vital functions and the structures of
the body. This vital force when imbalanced due to the above factors affects the development of
fetus and ends up with serious deformities to the child. Because if vata is in imbalanced stage,
definitely child will become mentally and/or physically abnormal. Ayurveda has mentioned the role
of doshaja (both sareeraka & manasika) and ajantuja factors in development of the disease
pathogenesis. The rajoguna &tamoguna (manasika dosha) along with vata, pitta, & kapha
(sareeraka dosha) will play an important role for the development of this disease.
Severity of Mental Retardation
Depending on the severity of intellectual impairment ICD –10 classifies the mental
retardation in to following degrees.
F 70 Mild mental retardation IQ of 50-69
F 71 Moderate mental retardation IQ of 35-49
F 72 Severe mental retardation IQ of 20-34
F 73 Profound mental retardation IQ < 20
The Intelligence quotient (IQ) score is used in the measurement of intelligence. IQ tests are
designed in such a fashion that an average individual gets a score of 100. As mentioned earlier, an
IQ of less than 70 is the criterion for falling in the range of mental retardation. Common IQ tests
that are used in India are Binet Kamat Test (BKT), Vineland Social Maturity Scale (VSMS),
Development Assessments scale for Indian Infants (DAS II), Seguin Form Board (SFB) and Malin
Intelligence Scale for Indian Children (MISIC).
II. OBJECTIVE
To study the efficacy of Ayush Manas for one year, in children with mental retardation in
terms of improving their intellectual function as measured by the IQ or SQ.
357
III. SAMPLE SIZE &METHODS
Study design: 12 months prospective double blind placebo controlled design is proposed. Patients
while e & f are optional / to selected patients.
Sample Size: Sample size would be 60 in active drug arm and 60 in the placebo group.
Drug/Dosage/ Duration
The subjects will be randomized to ayush Manas and placebo in a 1:1 ratio with
approximately 60 patients assigned to each group. Active treatment will be given for one year.
The drug Ayush Manas (250/tab) will be given at a dose of 2 tablets tid with water, which
contains equal parts of brahmi, manduka parni, jyothishmathi and ashwagandha.
Study procedures
Subjects will visit the investigator six times during the trial. The initial visit is screening phase
(visit 0), and subsequently after 1 to 4 weeks of initial wash out period (visit 1), after 3 months
(visit 2), 6 months (visit 3), 9 months (visit 4), 12 months (visit 5) and 6th visit will be at 15th
month. Visit 0 will be considered as the screening, visit I will be considered, as the baseline visit
where the trial begins and visit 5 will be the end of active treatment. On visit 1(base line visit), the
investigator after ensuring compliance with inclusion and exclusion criteria will propose the study to
the patient and obtain informed consent for each subject from the parent or guardian. A complete
medical history will be obtained. This will include patient demographics, significant past and present
illness or surgical procedures, concomitant medication data and VSMS – Malin’s version. A
physical examination will be done and include the recording of height, weight heart rate and blood
pressure. Diagnosis of Mental Retardation will be made according to VSMS – Malin’s version
criteria for Mental Retardation. Laboratory investigations will be done as per CRF (case recording
file) at base line (visit 1), after 3 months (visit 2) and at the end of the active treatment (visit5).
IV. CRITERIA FOR INCLUSION
1. Children of either sex aged in between 6 to 13 years.
2. Children with mild to moderate Mental Retardation.
V. CRITERIA FOR EXCLUSION
Children with a history of peptic ulcer disease, any gastric or duodenal surgery,
gasterointestinal (GI) bleeding or other GI disorders.
1. Children with severe infection and/or clinically significant hepatic, respiratory, renal, cardiac
or hematological disorders.
2. Children with abnormal laboratory values at admission in to the study: serum creatinine 1.2
mg/dl, SGOT, SGPT >2times uppr limit of normal; serum bilirubin or Alkaline phosphatase
>1.5 times upper limit of normal.
358
3. Subject’s guardian who cannot be relied upon to comply with the test procedures or are
unwilling to give informed consent.
4. The Children had any intramuscular, intra-articular or intravenous carticosteroids within 4
weeks prior to study entry.
5. The Children has likelihood of requiring treatment during the study period with drugs not
permitted by the study protocol.
6. The Children with a history of recent and clinically significant drug abuse.
7. The Children with pre-existing blood dyscrasias, eg., bone marrow hypoplasia, leukopenia,
thrombocytopenia etc.
8. The Children is unlikely to comply with protocol, eg., un cooperative attitude, inability to
return for follow-up visits, and unlikelihood of complete study.
9. Children in whom another investigational drug was used with in 3 months prior to entry in
this study.
10. Children with mental retardation suffering with active epilepsy (H/o attack in last 3 months).
11. Children to whom Binet Kamat Test (BKT) can’t be administered for any reason such as
speech delay, severe hyperkinesias etc.
VI. CRITERIA FOR WITHDRAWAL
A discontinuation occurs when an enrolled subject ceases participation in the study,
regardless of the circumstances, prior to completion of the study. The reason for withdrawal
should be recorded in the CRF, dated and signed. Efforts should be made to ascertain the reason
for discontinuation.
Discontinuation can be due to:
1. Non-compliance with the study medications and specified visits
2. Serious clinical events requiring specific treatment
3. At subject’s/ guardian’s request.
The final evaluation required by the protocol at the end of the study, will be performed at
the time of study discontinuation.
VII. ROUTINE INVESTIGATION AND ASSESSMENT
The following laboratory tests will be performed on at base line (visit 1), after 3 months
(visit 2) and at the end of the active treatment (visit5).
359
The laboratory tests include:
Hematology: Hemoglobin, haematocrit, RBC count, TLC, DLC, platelet count, erythrocyte
sedimentation rate (ESR), bleeding time, clotting time, prothrombin time.
Biochemistry: Total bilirubin, SGPT, SGOT, alkaline phosphotase, creatinine, blood sugar,
serum protein and albumin.
Urinanalysis: Albumin, microscopic haematuria, Urine for abnormal metabolites.
The laboratory test results will be recorded in CRF.
VIII. CLINICAL ASSESSMENT
Using study instruments in each visit will assess all Children who fulfill the inclusion and
exclusion criteria and whose parent/guardian provides written informed consent.
Instruments - a. Detailed clinical proforma for Mental Retardation
b. Binet Kamat Test (BKT)
c. Vineland Social Maturity Scale (VSMS) – Indian adaptation by Malin
d. Maladaptive Behavior Scale (Part II of ABS of AAMR)
e. Seguin Form Board (SFB)
f. Malin’s Intelligence Scale for Indian Children (MISIC)
a, b, c & d will be administered to all the patients while e & f are optional / to selected patients.
SAFETY RECORDING
a. Adverse Events
All adverse events observed or reported by patients will be recorded in the CRF with
information about severity (i.e., whether mild, moderate or severe) and possible relation to the
study medication. Any serious adverse effects must be notified immediately to the study monitor.
b. Safety Measures
Safety evaluation will perform by recording clinical adverse events at randomization
(baseline) and at the subsequent clinical visits. Further adverse events will be classified according
to their type, severity and possible relationship to treatment. At Visit 1 the subject’s medical history
will be recorded. At monthly visits vital signs (body temperature, pulse, blood pressure) will be
recorded and a physical examination will be performed (Abnormal Lab reports listed in appendix
3).
360
IX. TRIAL MONITORING AND DATA ANALYSIS
A qualified statistician will perform the statistical analysis. All available data will be used in
the analysis. In general all statistical tests will be performed at the 5% level of significance.
X. ETHICAL REVIEW
Ethics Committee: The study will be performed in accordance with the principles stated
in the Declaration of Helsinki (enclosed Appendix 2). Ethical approval of the study protocol will
be obtained from the Ethics committee at institutions where the study will be conducted before the
study is undertaken. The opinion of the Ethics Committee should be dated and given in writing.
Whenever possible, the names and titles of the members attending the Ethics Committee meeting
should be appended. The approval must clearly identify the protocol and other documents
submitted for review, by title and study code.
XI. TRAVELING EXPENSES FOR RESEARCH SUBJECTS
A consolidated amount of Rs.100/- per visit i.e., on the 1st day of recruitment after
screening, 1st, 2nd, 3rd month (4 times)
XII. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
Short-term two-day training will be provided to the Investigators involved in the
multicentric trial at CCRAS Hqrs. New Delhi. The investigators will be detailed about the clinical
trial conduct and laboratory procedures in order to maintain the uniformity.
XIII. LABORATORY INVESTIGATIONS
The Laboratory Investigations (Haematological /Biochemical, etc.), which are not available
at research Institutes should be conducted at identified reputed labs /Government Institutes under
intimation to this Council following codal formalities.
361
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF “AYURVEDIC CODED DRUG
(AYUSH MANAS)” IN THE MANAGEMENT OF “MANASA MANDATA
(MENTAL RETARDATION)”
PATIENT INFORMATION SHEET
362
Problems and side effects, which are not known at this time, could occur. I will be told of
any changes in the way the study will be done and of any newly identified risks to which my child
may be exposed.
I shall inform the physician about any illness that my child may have suffered in this study
period and the treatment required for it.
Patient participation
Participation in this study is entirely voluntary. If I do not desire to enroll my child for the
study the child’s treatment will continue as per the routine of the institute.
Possible benefits of the study
The costs of the all tests, examinations and medical care required as a part of this study
are to be provided free of cost to me. My child may respond favorably to treatment and others
may benefit from the overall conclusions to be drawn from the results of this study. There is no
guarantee that my child will benefit from participating in this study.
Withdrawal from this study
The investigator in charge of this study can remove my child from the study without my
consent based on his/her judgment to improve my child’s medical care or my failure to follow the
study schedule.
Compensation
If my child is injured as a direct result of taking part in this study, I understand that
medical treatment and other related costs should be made available by CCRAS, New Delhi.
Right to withdraw from the study
I am free to leave this study at any time without giving any reason. My decision of not
participating in this study or to leave the study in between shall not affect my child’s future medical
care.
Confidentiality
The records obtained during the study as well as related health records will remain strictly
confidential at all times. However, I understand that these will need to be made available to
CCRAS, New Delhi, to other doctors/scientists of this study and if required to the drug regulatory
authority. The information disclosed will remain confidential. The results of the treatment, including
laboratory tests, photographs may be published for scientific purposes provided my child’s identity
is not revealed.
Data protection: Use of data collected from this study
My child’s personal data, which may be sensitive, will be collected and processed only for
research purposes in connection with this study. By taking part in this study, I agree not to restrict
the use of any data even if I withdraw.
363
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF “AYURVEDIC CODED DRUG
(AYUSH MANAS)” IN THE MANAGEMENT OF “MANASA MANDATA
(MENTAL RETARDATION)”
WRITTEN INFORMED CONSENT FORM
(By parent/guardian of the patient)
I,…………………………………………………………………………………………Father/
Mother/Guardian of………………………………………, exercising my free power of choice
give my consent on my as well as my child’s behalf to be included in this study on one-year
prospective double blind placebo controlled clinical evaluation of “Ayurvedic coded drug (AYUSH
MANAS)” in the management of “Manasa Mandata (Mental Retardation)”. I have read, or had
read to me, the above information before signing this consent form. I have been provided ample
opportunity to ask questions and have received answers that fully satisfy those questions. I have
been informed to my satisfaction by the attending physician the nature and purpose of the study.
I understand that the clinical details and information recorded as part of the study will be
kept confidential.
I am also aware of my right to withdraw out of this study at any time during the course of
the study without having to assign the reason for doing so.
364
CENTRAL COUNCIL FOR RESEARCH IN A YURVEDA AND SIDDHA
CLINICAL EVALUATION OF HERBOMINERAL PREPARATIONS IN THE
MANAGEMENT OF MANASA MANDATA (MENTAL RETARDATION)
CASE REPORT FORM – I SCREENING
(Enter a in the appropriate box)
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF THERAPEUTIC EFFICACY OF AYUSH-M NASAL DROPS
AND AYUSH-M CAPSULE IN THE MANAGEMENT OF MIGRAINE WITH
OUT AURA (ARDHAVA BEDHAKA)
CASE RFPORT FORM II - HISTORY
2. Address : _______________________________________________________________
_______________________________________________________________
4. Centre : __________________________________________________________________
6. Patient No.
Third 3 Fourth 4
9. Educational status:
10. Occupation
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Total income of the family in rupees : .......................................................
15. Seizures 1 0
367
Medicines given ________________________ Results obtained ______________________
Yes 1 No 2
Personal History
34. Prakriti
Sannipataj 7
368
35. Manas Prakriti
Sama 7
Physical Examination:
41. Cyanosais 1 0
42. Anaemia 1 0
43. Jaundice 1 0
44. Pigmentation 1 0
46. Deformities 1 0
47. Lymphadenopathy 1 0
49. CNS 1 2
369
50. Digestive System 1 2
Vyakti 4 Bheda 5
SROTAS PAREEKSHA
370
Oustha sosha (Dryness of lip) 2
Trishna (Thirst) 6
Aruchi (Anorexia) 2
Avipaka (Indigestion) 3
Chhardi (Vomitting) 4
Arasajnata (Tastelessness) 2
Tandra (Stupor) 5
Jwara (Fever) 7
Pandu (Anaemia) 8
Avsada (Depression) 9
Karshya (Emaciation) 11
371
63. Rakta Vaha Srotas
Pidika (Boils) 1
Vidradhi (Abscess) 4
Kamala (Jaundice) 6
Arubuda (Tumour) 1
Upjivihika (Epiglotitis) 4
Tandra (Stupor) 4
Alasya (Lethargy) 6
372
Adhidanta (Redundant tooth) 2
Dantshoola (Toothache) 3
Bhrama (Vertigo/Giddiness) 2
Moorchh (Syncope) 3
Mithyajnana (Illusion) 4
Klaivya (Sterility/impotence) 1
Manovibramsha 1
Budhivibramsha 2
Samjavibramsha 3
Smritivibramsha 4
Bhktivibramsha 5
Sheelavibramsha 6
Chesta vibramsha 7
Acharavibramsha 8
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70. Artava vaha srotas -
Anartava (Amenorrhoea) 1
Vandhyatva (Sterlity) 2
Bahumutrata (Polyuria) 1
Lomaharsha (Thrill) 4
374
74. Investigations
Clinical assessment
Duration of treatment
Dropout 5 LAMA 6
Death 7
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF HERBOMINERAL PREPARATIONS IN THE
MANAGEMENT OF MANASA MANDATA (MENTAL RETARDATION)
CASE REPORT FORM – III INVESTIGATION
2. Address: _______________________________________________________________
_______________________________________________________________
3. Centre: __________________________________________________________________
5. Patient No.
Investigations
10. HB %
12. D.L.C.
Basophil : . . . . . . . . . . %
Eosinophil : . . . . . . . . . . %
376
13. E.S.R. : 1 Hr . . . . . . . mm
: 2 Hr . . . . . . . mm
Biochemistry:
Special Tests
23. EEG
Note: Only such investigations are to be undertaken for which facilities exist in the Institutes/
Centres/Units themselves, unless exempted.
377
INFORMED CONSENT (APPENDIX 1)
Informed consent will be obtained from each subject in the prescribed format prior to
performance of any study related procedures: before physical examination, laboratory screening or
any other investigational procedure and before administration of any study related medication. The
investigators will give each subject full information about the nature, meaning and importance of the
study and a description of the procedures to be followed by the investigator in accordance with
Declaration of Helsinki (Appendix 2). They will further be given a description of any foreseeable
risks and discomforts. Subjects will also be told that they have the right to opt out of the trial at
any time without having to give reasons and without prejudice to further treatment. Each subject
will be given a copy of the subject information sheet and will be given sufficient time to consider
the implications of the study before deciding whether or not to participate in the trial.
The subject and the investigator must sign the informed consent form. At this time the
subject must have legal capacity and be able to comprehend the nature, meaning, importance and
risks of the study and to make up his mind accordingly. If the subject is illiterate, an impartial
witness (a person, who is independent of the trial and who cannot be unfairly influenced by people
involved in the trial) will attend the informed consent form in a language known to the subject.
Signed informed consent means the explicit acceptance that the Investigator(s), the sponsor and,
possibly, the regulatory authorities, will know about the individual’s data.
378
DECLARATION OF HELSINKI (APPENDIX 2)
Introduction
It is the mission of the physician to safeguard the health of the people. His or her
knowledge and conscience are dedicated to the fulfillment of this mission.
The Declaration of Geneva of the World Medical Association binds the physician with the
words, “The health of my patient will be my first consideration,” and the International Code of
Medical Ethics declares that, “A physician shall act only in the patient’s interest when providing
medical care which might have the effect of weakening the physical and mental condition of the
patient.”
The Purpose of biomedical research involving human subjects must be to improve
diagnostic, therapeutic and prophylactic procedures and the understanding of the etiology and
pathogenesis of disease.
In current medical practice most diagnostic, therapeutic or prophylactic procedures involve
hazards. This applies especially to biomedical research.
Medical progress is based on research, which ultimately must rest in part on
experimentation involving human subjects.
In the field of biomedical research a fundamental distinction must be recognized between
medical research in which the aim is essentially diagnostic or therapeutic for a patient, and medical
research, the essential object of which is purely scientific and without implying direct diagnostic or
therapeutic value to the person subjected to the research.
Special caution must be exercised in the conduct of research, which may affect the
environment, and the welfare of animals used for research must be respected.
Because it is essential that the results of laboratory experiments be applied to human
beings to further scientific knowledge and to help suffering humanity, the World Medical
Association has prepared the following recommendations as a guide to every physician in
biomedical research involving human subjects. They should be kept under review in the future. It
must be stressed that the standards as drafted are only a guide to physicians all over the world.
Physicians are not relieved from criminal, civil and ethical responsibilities under the laws of their
own countries.
I. Basic Principles
Biomedical research involving human subjects must conform to generally accepted scientific
principles and should be based on adequately performed laboratory and animal experimentation
and on a thorough knowledge of the scientific literature.
379
1. The design and performance of each experimental procedure involving human subjects should
be clearly formulated in an experimental protocol which should be transmitted for
consideration, comment and guidance to a specially appointed committee independent of the
investigator and the sponsor provided that this independent committee is in conformity with
the laws and regulations of the country in which the research experiment is performed.
2. Biomedical research involving human subjects should be conducted only by scientifically
qualified persons and under the supervision of a clinically competent medical person. The
responsibility for the human subject must always rest with a medically qualified person and
never rest on the subject of the research, even though the subject has given his or her
consent.
3. Biomedical research involving human subjects cannot legitimately be carried out unless the
importance of the objective is in proportion to the inherent risk to the subject.
4. Every biomedical research project involving human subjects should be preceded by careful
assessment of predictable risks in comparison with foreseeable benefits to the subject or to
others. Concern for the interests of the subject must always prevail over the interests of
science and society.
5. The right of the research subject to safeguard his or her integrity must always be respected.
Every precaution should be taken to respect the privacy of the subject and to minimize the
impact of the study on the subject’s physical and mental integrity and on the personality of
the subject.
6. Physicians should abstain from engaging in research projects involving human subjects unless
they are satisfied that the hazards involved are believed to be predictable. Physicians should
cease any investigation if the hazards are found to outweigh the potential benefits.
7. In publication of the results of his or her research, the physician is obliged to preserve the
accuracy of the results. Reports of experimentation not in accordance with the principles laid
down in this Declaration should not be accepted for publication.
8. In any research on human beings, each potential subject must be adequately informed of the
aims, methods, anticipated benefits and potential hazards of the study and the discomfort it
may entail. He or she should be informed that he or she is at liberty to abstain from
participation in the study and that he or she is free to withdraw his or her consent to
participation at any time. The physician should then obtain the subject’s freely-given informed
consent, preferably in writing.
9. When obtaining informed consent for the research project the physician should be particularly
cautious if the subject is in a dependent relationship to him or her or may consent under
duress. In that case the informed consent should be obtained by a physician who is not
engaged in the investigation and who is completely independent of this official relationship.
380
10. In case of legal incompetence, informed consent should be obtained from the legal guardian
in accordance with national legislation. Where physical or mental incapacity makes it
impossible to obtain informed consent, or when the subject is a minor, permission from the
responsible relative replaces that of the subject in accordance with national legislation.
Whenever the minor child is in fact able to give a consent, the minor’s consent must be
obtained in addition to the consent of the minor’s legal guardian.
11. The research protocol should always contain a statement of the ethical considerations involved
and should indicate that the principles enunciated in the present Declaration are complied
with.
II. Medical Research Combined with Professional Care (Clinical Research)
1. In the treatment of the sick person, the physician must be free to use a new diagnostic and
therapeutic measure, if in his or her judgment it offers hope of saving life, reestablishing health
or alleviating suffering.
2. The potential benefits, hazards and discomfort of a new method should be weighed against
the advantages of the best current diagnostic and therapeutic methods.
3. In any medical study, every patient—including those of a control group, if any—should be
assured of the best proven diagnostic and therapeutic method.
4. The refusal of the patient to participate in a study must never interfere with the physician-
patient relationship.
5. If the physician considers it essential not to obtain informed consent, the specific reasons for
this proposal should be stated in the experimental protocol for transmission to the independent
committee (I, 2).
6. The physician can combine medical research with professional care, the objective being the
acquisition of new medical knowledge, only to the extent that medical research is justified by
its potential diagnostic or therapeutic value for the patient.
381
ABNORMAL LABORATORY RESULTS (APPENDIX 3)
Patients with markedly abnormal tests at the end of treatment period should be followed
up to satisfactory resolution.
ULN is defined as the upper limit of normal, depending on whether the pretreatment
baseline was normal or abnormal.
The follow up of abnormal laboratory tests described in the CRF will be recorded
accordingly.
382
SCHEDULE OF ASSESSMENTS (APPENDIX 4)
383
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384
SAMANA THERAPY VIS-A-VIS PANCHAKARMA
THERAPY IN THE MANAGEMENT OF GRIDHRASI
(SCIATICA)
385
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
SAMANA THERAPY VIS-A-VIS PANCHAKARMA THERAPY IN THE
MANAGEMENT OF GRIDHRASI (SCIATICA)
I. BACKGROUND
Pain starting from the gluteal region and spreading down the back of the lower limb and
radiating upto the foot is the main symptom of the Gridhrasi (Sciatica). There will be a limp gait
and difficulty in sitting. If pain is severe, the patient may not be able to move from bed. The pain
increases by coughing or sneezing. The patient suddenly seized with immobilizing and shooting pain
down the leg, starting from lower back.
The disease mostly affects the early and middle aged people. Occupations like heavy
weight lifting, continuous pressure on the back etc. are also main causative factors.
ETIOPATHOGENESIS
According to Ayurveda, in Gridhrasi1, the main vitiated Dosha is Vata. In Ashtanga
Hridaya and Sushruta Samhita, the descriptions of Gridhrasi are identical. However, Caraka’s
description differs. It classifies Gridhrasi into two types namely Vataja and Vatakaphaja.
Caraka’s description is very much similar to modern concept. According to Ayurvedic concepts
also, the origin of the disease is at Katipradesha (Lumbo - Sacral region).
Inspite of the fact that the spinal diseases are difficult to be cured, sciatic pain is not so
much harmful as other neurological conditions. Ayurvedic concept of treatment for Gridhrasi
(Sciatica) is more effective and suitable as compared to modern mode of treatment. On prolonged
use also, there is no side effect with Ayurvedic regimen of treatment. Several single and compound
herbal preparations like Bhallataka (Tripathy et. al., 1965). Nirgundi (Jain et. al., 1976) and
Hingutriguna Taila (Prem Kishore et. al., 1986) etc. have shown good response in the
management of Gridhrasi (Sciatica).
References
1. Charaka Samhita, Chikitsa Sthana Chapter– 28, Vidyotini Hindi Vyakhya by Vd. Ambikadatta
Shastry, Choukhamba Orientalia, Varanasi
2. Harrison’s Principles of internal medicine, 14th Edition, International Editions, 1998, Published
by Mc Graw-Hill CompaniesInc.pp1208-1209
3. Ambika Dutta Sashtri (1989) Susruta samhita (text with Hindi commentary) Nidana Sthana,
Chapter – 1, VIIth Edition Chaukhamba Sanskrit Series Office, Varanasi.
4. Bhaisajya Ratnavali, Krimiroga Chikitsa Prakarana, Chaukhamba Sanskrit Samsthan, Varanasi
387
Since inception, Indian Institute of Panchakarma has been concentrating Clinical
Research Trials on Gridhrasi in order to find out an effective line of treatment. Several Single and
Compound Ayurvedic preparations had been tried. Following are the main drugs in which Clinical
Trials have been already conducted in past. All the trials have shown significant result in the
management of Gridhrasi cases.
Typical pain radiation, caused due to irritation of the 4th and 5th lumber and 1st sacral
roots, from the sciatic nerve extending mainly down the posterior aspect of the thigh and posterior
and lateral aspects of the leg is termed as Sciatica. Twinkling, paresthesia and numbness of or
sensory impairment of the skin, soreness of the skin and tenderness along the nerve also
accompanies the classic sciatic pain and on physical examination reflex loss, weakness, atrophy,
fascicular twitching and occasionally stasis oedema may occur is the motor fibres of the anterior
root are involved.
Mild attacks least for a week or two. Other cases happen to be more chronic and
provide a history of remitting attacks. Favorable cases, rested absolutely on hard bed, may
recover with 4 – 6 weeks but recurrences are frequent. Foot drops seldom recovers completely.
Pelvic tractions help in some cases with disc lesions. Massage, spinal exercise and heat application
provide comfort and hence are useful. If there is no improvement by providing bed rest and there
are recurrent disabling attacks, surgical removal of the disc is suggested.
II. OBJECTIVES
The study aims to assess the Comparative Clinical Evaluation of Dasamoola Bala Kwatha
(Internal) along with Dasamoola Bala Taila (Internal and External) in one group and
Panchakarma Therapy with its different procedures in another group in the management of
Gridhrasi (Sciatica). The drug Dasamoola and Bala are well known for their Vatahara
properties.
III. CENTER:
CCRAS identified Centers
IV. SAMPLE SIZE AND METHODS:
Sample Size: 100 cases
No of Groups: Two groups
Trial Drug/Dosage/Duration
Group – I: Samana Chikitsa
a). Dasamoola Bala Taila – 10 ml. to 15 ml. thrice daily X 14 days.
i). Dasamoola Bala Kwatha – 10 – 15 ml. thrice daily X 14 days.
388
ii). Nirgundi Patrapotala Sweda after Abhyanga with Dasamoola Bala
Taila X 14 days.
b). Virechana X 1 day with Eranda Taila 30 ml., after completing the
Patrapotala Sweda
389
VI. CRITERIA FOR EXCLUSION
1. Age below 20 years and above 70 years
2. Duration of disease more than 2 years
3. Monoplegia
4. Paraplegia
5. Hip joint arthritis
6. T.B. Spine/Hip
7. Pelvic pathology
8. Traumatic lesion in lumbo - sacral region
VII. CRITERIA FOR WITHDRAWAL
1. Left against medical Advise (LAMA)
2. Development of complications due to presenting illness or otherwise
3. Aggravation of symptoms
Pronounced toxic side effects
VIII. ROUTINE EXAMINATION AND ASSESSMENT
Screening of the patient will be recorded as per case record form - I. Detailed clinical
history and physical examination of each patient will be recorded as per Part – II of the Proforma
annexed. Pathological, Biochemical and other relevant investigations will be carried out as per Part
– III of the proforma. The assessment of the results will be done according to effect of the Trial
Groups on each of the sign and symptom. Each sign and symptom is graded and a numerical
value is given for assessment of results. (as per case record form III).
Following criteria has been fixed for Routine Examination and Assessment.
1. Pricking pain 6
2. Pulling pain 6
3. Stiffness 3
4. Tenderness of sciatic trunk 6
5. Straight leg raising test/positive 54
jugular vein pressure test
6. Ankle jerk 2
390
7. Knee jerk 2
8. Plantar reflexes 2
9. Pressing power 3
10. Muscle wasting 3
11. Walking speed 3
12. Sensory impairment 2
13. Posture 8
Total 100
Symptoms were suitably graded to assess the degree of involvement. The assessment chart
is annexed at Part – IV of the Proforma.
IX. CRITERIA FOR ASSESSMENT
Result of treatment will be graded as follows:
1. Good Response : Complete relief in presenting symptomatology of the disease.
2. Fair Response : 75% and above relief of signs and symptoms.
3. Poor Response : 50% to 74% relief of signs and symptoms
4. No Response : No response in presenting clinical symptomatology of disease or
otherwise.
X. TRIAL MONITORING AND DATA ANALYSIS
The progress of the study will be monitored by team comprising of Clinicians, Pathologists,
Biochemists, Radiologists and Statisticians.
XI. STATISTICAL ANALYSIS
Before treatment and after treatment, data signs/symtoms and other parameters taken into
account for diagnosis and assessment of result of treatment will be tabulated and analyzed using
suitable statistical methods.
XII. TRIAL MONITORING AND DATA ANALYSIS
CCRAS, Hqrs, New Delhi will undertake the monitoring of progress of the trial and data
analysis.
391
XIII. ETHICAL REVIEW
A. Ethical Committee (IEC): The proposal will be placed before Ethical Committee (IEC)
of trial center for getting clearance certificate before the project is initiated. Patient’s
information sheet and informed consent form will be submitted along with project proposal
for approval by EC. Both will be maintained in duplicate with one copy given to the
patient at the time of entry to the trial.
XIV. TRAVELING EXPENSES FOR RESEARCH SUBJECTS
A consolidated amount of Rs……. /- per visit.
XV. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
Short-term two-day training will be provided to the Investigators and Laboratory
personnel involved in the multi-centric trial at CCRAS Hqrs. The investigators and technicians will
be detailed about the clinical trial conduct and laboratory procedures in order to maintain the
uniformity.
XVI. LABORATORY INVESTIGATIONS
The Laboratory Investigations (Pathological/Biochemical, etc.), which are not available at
research Institutes should be conducted at identified reputed labs /Government Institutes under
intimation to this Council following codal formalities.
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
WRITTEN INFORMED CONSENT FORM
CERTIFICATE BY INVESTIGATOR
I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature of the subject: ______________
Name: ____________________________
CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending physician, the purpose of the
clinical trial and the nature of drug treatment and follow-up, including the laboratory investigations
to be performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so. I am willing to undergo any risk for inclusion in
this study.
I, exercising my free power of choice, hereby give my consent to be included as a subject
in the clinical trial on “Samana therapy vis-a-vis panchakarma therapy in the management
of gridhrasi (sciatica)”
Relationship ___________________________________
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
SAMANA THERAPY VIS-A-VIS PANCHAKARMA THERAPY IN THE
MANAGEMENT OF GRIDHRASI (SCIATICA)
PATIENT INFORMATION SHEET
394
Before you start treatment, during the first visit to the clinic, you will undergo a
complete physical examination, required objective tests and laboratory investigations will
also be done.
If you are found eligible, you would be put on treatment for Samana Chikitsa for
a period of 22 days while Panchakarma Chikitsa will continue for a total period of 25 –
26 days.
At each visit, you will be supplied with sufficient quantities of drugs to last until
your next visit. If any adverse reactions like skin allergy, nausea, vomiting and
palpitation/tremor etc., noticed during the treatment period, this should be noticed to the
Principle Investigator.
395
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA & SIDDHA
SAMANA THERAPY VIS – A – VIS PANCHAKARMA THERAPY IN THE
MANAGEMENT OF GRIDHRASI (SCIATICA)
CASE REPORT FORM I – SCREENING
BEFORE TREATMENT
(Enter a in the appropriate box)
2. Address: ...............................................................................................................................
3. Centre:
5. Patient No.
6. Group No
396
16. Monoplegia 1 0
17. Paraplegia 1 0
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA & SIDDHA
SAMANA THERAPY VIS – A – VIS PANCHAKARMA THERAPY IN THE
MANAGEMENT OF GRIDHRASI (SCIATICA)
CASE REPORT FORM II – HISTORY
(Enter a in the appropriate box)
2. Address : ..............................................................................................................................
4. Centre :
6. Patient No.
7. Group No
9. Educational status:
398
13. Religion: Hindu 1 Muslim 2 Sikh 3
Christian 4 Parsi 5
Unani 3 Homoeopathy 4
399
28. Factors aggravating the disease/chief complaints
Yes No
31. Hypertension 1 0
34. Cancer 1 0
36. Tuberculosis 1 0
Personal History
Loose Stool 4
400
41. Dependency Yes 1 No 2
42. Prakriti
Sannipataja 7
Sama 7
Physical Examination
50. Pulse
51. Respiration
Present Absent
52. Cynosis 1 0
53. Anaemia 1 0
54. Jaundice 1 0
401
55. Pigmentation 1 0
57. Deformities 1 0
58. Lymphadenopathy 1 0
Systemic Examination
Present Absent
60. C.N.S. 1 0
Local Examination
Yes No
402
67. Sensory impairment 1 0
Snayu 4 Kandara 5
SROTAS PARIKSHA
74. Arubuda 1 0
403
85. Angamarda (Body ramps) 1 0
Provisional Diagnosis:
Final Diagnosis:
Medical Management:
Dose —
Vehicle —
Diet —
Summary of findings:
102.Results:
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA & SIDDHA
NEW DELHI
SAMANA THERAPY VIS – A – VIS PANCHAKARMA THERAPY IN THE
MANAGEMENT OF GRIDHRASI (SCIATICA)
PROFORMA
CASE REPORT FORM III – CLINICAL ASSESSMENT
2. Address : ..............................................................................................................................
3. Centre :
5. Patient No.
6. Group No
Clinical Parameters:
1. Pricking pain
Absent — 0
Mild — 2
Moderate — 4
Severe — 6
405
2. Pulling Pain
Absent — 0
Mild — 2
Moderate — 4
Severe — 6
3. Stiffness
Absent — 0
Mild — 1
Moderate — 2
Severe — 3
0 — 54
10 — 48
20 — 42
30 — 36
40 — 30
50 — 24
60 — 18
70 — 12
406
80 — 6
90 — 0
c. Ankle jerk
Present — 0
Exaggerated — 1
Absent — 2
d. Knee jerk
Present — 0
Exaggerated — 1
Absent — 2
e. Planter
Present — 0
Up going — 1
Absent — 2
f. Pressing power
b).10 to 20 Kg. — 2
c). 20 to 25 Kg. — 1
g. Muscle wasting
Thigh:
407
Calf:
Measurement:
— L
— L
b). 21 to 40 seconds — 1
c). 41 to 60 seconds — 2
i. Sensory impairment — 2
j. Posture — 8
a). No Complaint — 0
408
g). Can stand without touching the affected limb — 6
on the floor
Foot Note: Any abnormalities in Lab. Parameters recorded at the time of admission that may
be considered during the assessment of the progress of the case and also during
follow up period.
Modern Diagnosis
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA & SIDDHA
NEW DELHI
SAMANA THERAPY VIS – A – VIS PANCHAKARMA THERAPY IN THE
MANAGEMENT OF GRIDHRASI (SCIATICA)
CASE REPORT FORM IV – LABORATORY INVESTIGATIONS
(Enter a in the appropriate box)
2. Address : ..............................................................................................................................
3. Centre :
5. Patient No.
6. Group No
7. Sugar 1 0 1 0 1 0 1 0
8. Albumin 1 0 1 0 1 0 1 0
9. Bile Salt 1 0 1 0 1 0 1 0
11. Microscopy 1 0 1 0 1 0 1 0
410
Stool:
12. Ova 1 0 1 0 1 0 1 0
13. Cyst. 1 0 1 0 1 0 1 0
14. Occult 1 0 1 0 1 0 1 0
Hematological Investigations:
15. Hb%
16. T.L.C.
17. Polymorph
18. Lymphocyte
19. Basophil
20. Monocyte
21. Eosinophil
22. E.S.R.
Biochemistry:
24. Urea
26. VDRL 1 0 1 0 1 0 1 0
28. Pelvis 1 0 1 0 1 0 1 0
411
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412
CLINICAL EVALUATION OF HERBAL PREPARATIONS
IN THE MANAGEMENT OF MANODVEGA
(ANXIETY NEUROSIS)
413
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF HERBAL PREPARATIONS IN THE
MANAGEMENT OF MANODVEGA (ANXIETY NEUROSIS)
I. BACKGROUND
Life is a conglomerate of body (Shareera), faculties (Indriya), mind (Satva), and soul
(Aatma). Any of these cannot be isolated and studied separately. So seers of Ayurveda express
that the term ‘Shareera’ refers body including five senses and mind.
As mind is a dual faculty (Ubhayendriya) or sensory-motor faculty (J’nana-Karmendriya),
it perceives and responds. Even the physical well being is reflected in mind, so is the illness. This
made the terms happiness (Sukha), and misery (Dukha), synonyms of health and illness. The
influence of mind cannot be ruled out in origin, existence or cure of any condition of any disease.
When allowed to persist for long time the psychic and somatic disorders get combined with each
other.
Chittodwega/ Manodwega is one of the Manasika Vikara mentioned in Ayurvedic
literature. The symptoms of this disease can be assumed mostly similar with the generalized
anxiety disorder (GAD). GAD is a disorder requires the presence of unrealistic or excessive
anxiety and worry, accompanied by symptoms from three of four categories: (1) motor tension, (2)
autonomic hyperactivity, (3) vigilance and scanning, and (4) apprehensive expectation. The anxious
mood must continue for at least a month.
The Ayurvedic principle of synthesis of mind, body and soul to consider man as integrated
whole one, would help to treat mental disorders effectively. Medhya rasayanas and Satvavajaya
chikitsa are such a measures, which can be utilized for the treatment of Chittodwega/
Manodwega1.
In Chittodwega/ Manodwega2, when the mind is afflicted with anxiety, fear, agitation etc.
this leads to worry, apprehension, depression, psychological arousal as anger, irritability and
ultimately lead to disturbance in personal, familial and social harmony.
References
1. Charaka Samhita with Ayurveda Dipika commentary of Chakrapanidatta, Chaukhambha Sanskrit
Sansthan, 5th edition, Varanasi, 2001
2. Sushruta Samhita with Nibandha Sangraha commentary of Dalhana and Nyayachandrika
commentary of Gayadasa, Chaukhambha Orientalia Varanasi, 6th edition, 1997.
3. Harrison: Principals of Internal Medicine Vol. II, 13th edition (International edition).
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Anxiety disorders3 are among the most prevalent psychiatric condition in the world.
Further, studies have persistently shown that they produce inordinate morbidity, utilization of health
care services, and functional impairment. Recent studies also suggest that chronic anxiety disorder
may increase the rate of cardiovascular-related mortality. Hence, clinicians in psychiatry and other
specialties must make the proper anxiety disorder diagnosis rapidly and initiate treatment.
Ayurveda provides rational means for the treatment of many disorders, which are
considered to be obstinate and incurable in other systems of medicine.
II. OBJECTIVES
To evaluate the anti-anxiety effect of an ayurvedic compound drug in patients suffering with
manodwega.
To evaluate efficacy & safety of ayurvedic compound drug in manodwega patients
The efficacy of ayurvedic compound drug for six weeks have been studied on manodwega
in terms of relieving from the symptoms pridictable through ayurvedic clinical parameters &
hamilton’s rating scale for anxiety neurosis.
III. CENTRES
CCRAS identified centers
IV. SAMPLE SIZE AND METHODS
Sample Size : 24 patients in each group (2 groups).
Trial period : 45 Days
Design of the study : Sequential crossover design and double blind method are
adopted.
Drug & dosage : The Ayurvedic compound consists of Mandukaparni
(Centella asiatica), Yasti (Glycyrrhiza glabra), Jatamamsi
(Nardostachys jatamansi) in the ratio of suspended in the
Kshirabala Thaila. The daily dose of Ayurvedic drug is
3gms. / Day in 3 divided doses. Each capsule contains
500mgs of drug i.e.Mandukaparni (120mg), Yasti (120mg.)
Jatamamsi (240mg.) and ksheerabala taila (3 drops).
The daily dosage of diazepam is 15mg. /day also in three
divided doses. The placebo is plain starch powder.
Duration of the study : 45 days drug therapy with a follow up for 7 days.
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Study period : 1 year to complete study.
Follow – Up : The follow-up will be carried out after 7 days of treatment.
V. CRITERIA FOR INCLUSION
1. Age between 16-45 years of either sex
2. Presence of cardinal features of manodwega
3. Onset between 8weeks to 2 years
4. Ambulatory and co-operative
VI. CRITERIA FOR EXCLUSION
1. Age below 16 yrs. and above 45 yrs.
2. Duration of the disease – below 8weeks and above 2years.
3. Exhibiting psychotic symptoms
4. Factors interfering with concentration and communication
5. Hypertension
6. Diabetes
7. Any other systemic diseases
VII. CRITERIA FOR WITHDRAWAL
1. If patient does not follows the instructions.
2. Any complication developed during the course of trial.
VIII. ROUTINE EXAMINATION AND ASSESSMENT
A detailed clinical and social history is taken. The patients assessed on the basis of clinical
parameters and Hamilton’s anxiety rating scales.
IX. METHOD OF ASSESSMENT OF TREATMENT
1. Clinical Symptomatic Relief
2. Psychological parameters
3. Hamilton’s anxiety rating scale
X. STATISTICAL ANALYSIS:
Data on clinical symptoms and objective tests before and after the treatment will be
tabulated and analyzed using appropriate statistical tools. However, the data of each case will have
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to be communicated on completion of trial therapy to the Statistical Officer of CCRAS through e-
mail.
XI. TRIAL MONITORING AND DATA ANALYSIS:
CCRAS, Hqrs, New Delhi will undertake the monitoring of progress of the trial and data
analysis.
XII. ETHICAL REVIEW:
A. Ethical Committee (IEC): The proposal will be placed before Ethical Committee (IEC)
of trial center for getting clearance certificate before the project is initiated. Patient’s
information sheet and informed consent form will be submitted along with project proposal
for approval by EC. Both will be maintained in duplicate with one copy given to the
patient at the time of entry to the trial.
B. Data and safety monitoring board: A Data and safety monitoring board (DSMB) at
Hqrs. will carefully monitor the data and side effects during the period of study and put in
a place where by prompt reporting of adverse events occur. The data will be reviewed as
every 20 participants entered the study and administered the trial drugs. The research team
will report immediately to the PI and Data Monitoring Board if, any life threatening
conditions whether they are perceived to be study related or not. The Board decides
whether the adverse effects warrant discontinuation of the study protocol. Protocols will be
written and approved for the treatment of study related adverse events.
XIII. TRAVELING EXPENSES FOR RESEARCH SUBJECTS
A consolidated amount of Rs.100/- per visit i.e., on the 1st day of recruitment after
screening, 8th day, 15th day and so on upto 45th day (weekly once).
XIV. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
Short-term two-day training will be provided to the Investigators and Laboratory
personnel involved in the multi-centric trial at CCRAS Hqrs. and Central Research Institute (Ay.),
New Delhi. The investigators and technicians will be detailed about the clinical trial conduct and
laboratory procedures in order to maintain the uniformity.
XV. LABORATORY INVESTIGATIONS
The Laboratory Investigations (Pathological/Biochemical, etc.), which are not available at
research Institutes should be conducted at identified reputed labs /Government Institutes under
intimation to this Council following codal formalities.
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF HERBAL PREPARATIONS IN THE
MANAGEMENT OF MANODVEGA (ANXIETY NEUROSIS)
WRITTEN INFORMED CONSENT FORM
CERTIFICATE BY INVESTIGATOR
I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature of the subject: ______________
Name: ____________________________
CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending physician, the purpose of the
clinical trial and the nature of drug treatment and follow-up, including the laboratory investigations
to be performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so. I am willing to undergo any risk for inclusion in
this study.
I, exercising my free power of choice, hereby give my consent to be included as a subject
in the clinical trial on “Clinical evaluation of herbal preparations in the management of
Manodvega (Anxiety Neurosis)”.
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF HERBAL PREPARATIONS IN THE
MANAGEMENT OF MANODVEGA (ANXIETY NEUROSIS)
PATIENT INFORMATION SHEET
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At each visit, you will be supplied with sufficient quantities of drugs to last until
your next visit. If any adverse reactions like skin allergy, nausea, vomiting and
palpitation/tremor etc., noticed during the treatment period, this should be noticed to the
Principle Investigator.
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF HERBAL PREPARATIONS IN THE
MANAGEMENT OF MANODVEGA (ANXIETY NEUROSIS)
CASE REPORT FORM – I SCREENING
BEFORE TREATMENT
(Enter a in the appropriate box)
2. Address: ...............................................................................................................................
3. Centre:
5. Patient No.
6. Group No
5. Hypertension
6. Diabetes
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10. Exhibiting psychotic symptoms
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF HERBAL PREPARATIONS IN THE
MANAGEMENT OF MANODVEGA (ANXIETY NEUROSIS)
CASE REPORT FORM – II ADMISSION
2. Address : ..............................................................................................................................
4. Patient No.
6. Centre :
9. Group No.
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14. Income per capita per month in rupees :
16. Fear
Depersonalisation
Palpitation ____________
Unani 3 Homoeopathy 4
Siddha 5 Mixed 6
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25. Factors relieving main complaints
_______________________________________________________________________
26. History of past illness, having relation with present illness. Yes 1 No 0
Personal History
36. PRAKRITI :
Sannipataj 7
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37. MANAS PRAKRITI :
Sama 7
Physical examination
44. Pulse
45. Respiration
46. Cyanosis
47. Anaemia
48. Jaundice
50. Deformities
51. Lymphadenopathy
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53. CNS 0 1
Shkra or Artava 7
Sthanasamsraya 4 Vyakti 5
Bheda 6
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Srotas Pareeksha
Trishna (Thirst) 6
Aruchi (Anorexia) 2
Avipaka (Indigestion) 3
Chhardi (Vomitting) 4
Arasajnata (Tastelessness) 2
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Gaurava (Feeling of heaviness) 4
Tandra (Stupor) 5
Jwara (Fever) 7
Pandu (Anaemia) 8
Avsada (Depression) 9
Karshya (Emaciation) 11
Pidika (Boils) 1
Vidradhi (Abscess) 4
Kamala (Jaundice) 6
Arubud (Tumour) 1
Upji (Epiglotis) 4
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71. Medo vaha srotas
Tandra (Stupor) 4
Alasya (Lethargy) 6
Dantshoola (Toothache) 3
Bhrama (Vertigo/Giddiness) 2
Moorchh (Syncope) 3
Mithyajnana (Illusion) 4
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75. Manovaha srotas
Manovibramsha 1
Budhivibramsha 2
Sanjna Vibhramsha 3
Smritivibhramsha 4
Bhaktivibhramsha 5
Sheelavibhramsha 6
Chesta Vibhramsha 7
Acharavibhramsha 8
Anartava (Amenorrhoea) 1
Bahumutra (Polyuria) 1
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Atidrava Pureesha (Diarrhoea) 3
Lomaharsha (Thrill) 4
81. Investigations
Diet
Drop-out 5 LAMA 6
Death 7
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF HERBOMINERAL PREPARATIONS IN THE
MANAGEMENT OF MANODVEGA (ANXIETY NEUROSIS)
CASE REPORT FORM - III INVESTIGATIONS
Name : ...............................................................................................................................................
Age : ............................... Sex : .................. Date: ......................................................
Investigations Before starting After 45 days
treatment
URINE (24 hour sample)
1. 17 – hydroxyl-cortico steroids
2. 17- keto-steroids
3. Vanillyl mandelic acid (VMA)
4. Routine
HAEMATOLOGICAL INVESTIGATIONS :
5. Hb _________________ gm/dl
6. T.L.C. (in thousand/Cmm)
D.L.C
7. Polymorphs ________________ %
8. Lymphocyte ________________ %
9. Basophil ________________ %
10. Monocyte ________________ %
11. Eosinophill ________________ %
12. E.S.R. 1 hr ________________ mm
2 hr ________________ mm
BIOCHEMISTRY :
13. Blood Glucose (Random) _____________ mg/dl
14. Urea _____________ mg/dl
15. Blood lactic acid estimation if possible
16. S. Creatinine _____________ mg/ dl
17. ECG
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF HERBOMINERAL PREPARATIONS IN THE MANAGEMENT OF
MANODVEGA (ANXIETY NEUROSIS)
CASE REPORT FORM – IV PERIODICAL OBSERVATION & ASSESSMENT
Centre : ...................................................................... Date: ......................................................................................
Code No: ................................................................... Sr. No. of the subject: ...........................................................
Subject‘s Name: ......................................................... Sex: .................................................. Age: ...........................
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a. Subjective symptoms
1. Hamilton’s anxiety rating scale
2. Taylor’s manifest anxiety scale
b. Objective test
1. Work output (cancellation of 9s)
2. Perceptual discrimination
(Closing the Cs into Os)
3. Psychomotor performance tests
a. Hand precision (Finger dexterity test)
b. Hand steadiness (Steadiness tester)
c. Speed of response (Tapping board)
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METABOLIC DISORDERS
SECTION - VI
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PROTOCOL FOR MULTICENTRIC DOUBLE BLIND
PLACLINICAL TRIAL OF VYOSHADI GUGGULU IN
THE MANAGEMENT OF OBESITY (MEDOROGA)
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
PROTOCOL FOR MULTICENTRIC DOUBLE BLIND PRE-CLINICAL TRIAL
OF VYOSHADI GUGGULU IN THE MANAGEMENT OF OBESITY
(MEDOROGA)
I. BACKGROUND
Obesity (Medoroga) is a condition in which there is an excessive accumulation of fat in the
body. Framingham study showed that a 20% excess over the desirable body weight clearly
poses risk to health. This disease is a metabolic disease generally occurs in affluent societies. It is
associated with increased mortality by predisposing to the development of important diseases like
diabetes, hypertension, atherosclerosis, heart disease, arthritis, infertility etc. and diminishes the
efficiency and happiness of those affected.
Because of imbalance between energy intake and expenditure, the excess fat accumulates
in the body. Although no satisfactory etiological classification of obesity is well defined but number
of factors are known to be associated with its development. Obesity is most prevalent in middle
age, but it can occur at any stage of life. It is prevalent in high socio-economic group. There are
certain professions in which obesity is common. Familial tendency exists in many cases.
Endocrine factors and energy imbalance are also responsible for the obesity. There are certain
drugs which cause obesity like steroids, oral contraceptives, phenothiazine, insulin etc.
The following complications generally occur in this disease viz. - psychological and sexual
problems, mechanical disabilities, osteoarthrosis of knee, hip, lumbar spines, abdominal and
diaphragmatic hernias and varicose veins, exertion dyspnoea, metabolic disorders like non-insulin
dependent, diabetes mellitus (NIDDM), hyperlipidaemia, gall stones, hyperuricaemia and
cardiovascular disorders. Low cardia output increases susceptibility to hypertension and IHD.
The current line of management in modern medicine is not giving satisfactory response in
the treatment of obesity. At this juncture it becomes essential to explore the efficacy of certain
Ayurvedic drugs in the management of obesity. Guggulu is one of major ingredient of the trial drug
of this project, on which many scientific research studies, (experimental and clinical both) have
been conducted establishing its hypocholestraemic, anti-obesity and anti-atherosclerotic effect.
II. OBJECTIVE
The aim of the present study is to assess the efficacy of Vyoshadi guggul in the
management of obesity.
III. CENTRES
CCRAS identified centers.
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IV. SAMPLE SIZE AND METHODS
No. of Groups — Two
No. of patients in each group — 60
Sample Size — 120 (60 subjects in each group)
Drug/Dosage/Duration:
Drug — Vyoshadi Guggulu
Dosage — 1gram (2 capsules of 500 mg. each)
two times a day.
Duration — 6 months
Design of the study — Randomised Double blind placebo
controlled study.
Duration of the study — 6 months drug therapy with a
follow up for 3 months without
drug.
Total period of study — 9 months
V. CRITERIA FOR INCLUSION
1. Age above 25 years and below 60 years of either sex
2. Presence of obesity, i.e., weight is more than 20 % excess of the desirable weight
according to height, sex and age(according to annexed height and body weight table) Or
Age adjusted BMI above 85th percentile (Indian standard)
3. WHR i.e., Waist Hip Circumference ratio >0.95 in males and >0.8 in females
VI. CRITERIA FOR EXCLUSION
1 Age below 25 years and above 60 years
2. Obesity secondary to or associated with Hypothyroidism, hypertension, Diabetes mellitus,
hyperlipidemia or Cushing’s syndrome.
3. Any concomitant serious disorder of the liver, kidneys, heart, lungs or other organs.
4. Pregnancy and Lactation.
5. Person undergoing treatment for any other serious illness.
442
VII. CRITERIA FOR WITHDRAWAL
During the course of the trial, if any serious complication develops which requires urgent
treatment with other drugs and therapies, such subjects may be withdrawn from the trial. The
Investigator shall mention the probable cause of withdrawal.
VIII. ROUTINE EXAMINATION AND ASSESSMENT
The full details of history and physical examination of the patients will be recorded as per
the Case Record Form (Forms I & IA). Clinical assessment will be done before drug
administration (0), at the end of 1st month, 3rd month and 6th month during treatment and at the
end of 9th month follow up (Form II). The laboratory investigations will be recorded before
drug administration, at the end of three month, at the end of treatment (6 months) and at the end
of follow-up.(9th month) [Form III] .
IX. FOLLOW UP
Follow-up will be carried out for 3 months after completion of treatment.
X. STATISTICAL ANALYSIS
Clinical symptoms and laboratory parameters will be analyzed using appropriate statistical
methods.
XI. TRIAL MONITORING
Monitoring unit of CCRAS Headquarters, New Delhi will monitor the progress of the trial.
Data analysis will be undertaken by the Monitoring unit at CCRAS headquarter.
XII. ETHICAL REVIEW
A. Institutional Ethical Committee (IEC): The proposal will be placed before Ethical
Committee (IEC) of trial center for getting clearance certificate before the project is
initiated. Patient’s information sheet and informed consent form will be submitted along
with project proposal for approval by EC. Both will be maintained in duplicate with one
copy given to the patient at the time of entry to the trial.
B. Data and Safety Monitoring Board (DSMB): A Data and safety monitoring board
(DSMB) at Hqrs. will carefully monitor the data and side effects during the period of
study and put in a place where by prompt reporting of adverse events occur. The data will
be reviewed as every 20 participants entered the study and administered the trial drugs.
The research team will report immediately to the PI and Data Monitoring Board if, any
life threatening conditions whether they are perceived to be study related or not. The
Board decides whether the adverse effects warrant discontinuation of the study protocol.
Protocols will be written and approved for the treatment of study related adverse events.
443
XIII. TRAVELING EXPENSES FOR RESEARCH SUBJECTS
A consolidated amount of Rs……. /- per visit.
XIV. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
Short-term two-day training will be provided to the Investigators and Laboratory
personnel involved in the multi-centric trial at CCRAS Hqrs. The investigators and technicians will
be detailed about the clinical trial conduct and laboratory procedures in order to maintain the
uniformity.
XV. LABORATORY INVESTIGATIONS
The Laboratory Investigations (Pathological/Biochemical, etc.), which are not available at
research Institutes should be conducted at identified reputed labs /Government Institutes under
intimation to this Council following codal formalities.
444
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
PROTOCOL FOR MULTICENTRIC DOUBLE BLIND PRE-CLINICAL TRIAL
OF VYOSHADI GUGGULU IN THE MANAGEMENT OF OBESITY
(MEDOROGA)
WRITTEN INFORMED CONSENT FORM
CERTIFICATE BY INVESTIGATOR
I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature of the investigator ___________
Name: ____________________________
CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending physician, the purpose of the
clinical trial and the nature of drug treatment and follow-up, including the laboratory investigations
to be performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so.
I, exercising my free power of choice, hereby give my consent to be included as a subject
in the, “Multicentric double blind pre-clinical trial of vyoshadi guggulu in the management of obesity
(medoroga).
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
PROTOCOL FOR MULTICENTRIC DOUBLE BLIND PRE-CLINICAL TRIAL
OF VYOSHADI GUGGULU IN THE MANAGEMENT OF OBESITY
(MEDOROGA)
PATIENT INFORMATION SHEET
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
PROTOCOL FOR MULTICENTRIC DOUBLE BLIND PRE-CLINICAL TRIAL
OF VYOSHADI GUGGULU IN THE MANAGEMENT OF OBESITY
(MEDOROGA)
CASE REPORT FORM I - SCREENING
(Please tick wherever is applicable)
1. Centre: ______________________________
3. Address : _______________________________________________________________
4. Centre: ______________________________
Or
5. Endocrine disorders
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6. Diabetes mellitus
7. Hyper-tension
9. Malignancy
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
PROTOCOL FOR MULTICENTRIC DOUBLE BLIND PRE-CLINICAL TRIAL
OF VYOSHADI GUGGULU IN THE MANAGEMENT OF OBESITY
(MEDOROGA)
CASE REPORT FORM IA – HISTORY
1. Centre: ______________________________
4. Address : _______________________________________________________________
5. Centre: ______________________________
9. Educational status:
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Chief complaint with duration (if any) in days
13. Polyphagia
14. Polydipsia
Personal History
Sannipataja 2
If yes, Specify__________________________________________
PHYSICAL EXAMINATION
450
29. Body height (in cm.) _________________________
35. Cyanosis
36. Anaemia
37. Jaundice
38. Lymphadenopathy
40. C.N.S.
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Samprapti (pathogenesis) of the disease according to Ayurvedic concept
Anubandhya dosha
Anubandh dosha
Avaraka dosha
Ksheen dosha
Shukra Ojas
Srotas Pariksha
Tandra (Stupor) 4
Alasya (Lethargy) 6
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
PROTOCOL FOR MULTICENTRIC DOUBLE BLIND PRE-CLINICAL TRIAL
OF VYOSHADI GUGGULU IN THE MANAGEMENT OF OBESITY
(MEDOROGA)
CASE REPORT FORM II – CLINICAL AND ANTHROPOMATRIC ASSESSMENT
(0, 1, 3, 6, 9th months)
1. Centre: ______________________________
4. Address : _______________________________________________________________
5. Centre: ______________________________
9. Date of Assessment :
10. Polyphagia
11. Polydipsia
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Anthropometric assessment
Continuing (1)
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC DOUBLE BLIND CLINICAL TRIAL OF VYOSHADI
GUGGULU IN THE MANAGEMENT OF OBESITY (MEDOROGA)
(0, 3rd , 6th AND 9th MONTH)
FORM III – LABORATORY INVESTIGATIONS
1. Centre: ______________________________
4. Address : _______________________________________________________________
5. Centre: ______________________________
9. Date of Assessment :
Routine____________ Microscopic___________
12. TC (Cells/Cmm.)_____________________
13. DC: P (%) _______ L (%) _______ E (%) _______ M (%) _______ B (%) ________
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16. PCV (%) _______________
456
RANDOMISED DOUBLE BLIND CONTROLLED
CLINICAL TRIAL OF AYUSH-DIAB IN CONTROLLING
BLOOD SUGAR LEVEL IN Type 2 DIABETES
MELLITUS
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
RANDOMISED DOUBLE BLINDCONTROLLED CLINICAL TRIAL OF AYUSH-
DIAB IN CONTROLLING BLOOD SUGAR LEVEL IN Type 2 DIABETES
MELLITUS
I. BACKGROUND
Diabetes is a metabolic disorder; a comparable condition of Madhumeha specifically an
abnormality in the way of the body utilizes glucose, due to an absolute or relative deficiency of the
hormone insulin or resistance by the body tissues to the action of insulin.
Conventional modern medicine provides a number of drug of choice for controlling the
blood sugar level in the patients of diabetes mellitus type-2. However, with the prolonged
treatment doses of the drugs often needs to be increased to control the blood sugar level and a
time comes when patient has to be switched over to insulin. Such patients become cases of insulin
dependent diabetes mellitus. With a view to help the suffering community there is a need to find a
safer drug, which can be used to control the blood sugar level and such drug can be used safety
for longer periods.Ayurvedic classics provide references on herbal and herbo-mineral preparations
which can be safely used in controlling the blood sugar level in the patients of diabetes mellitus.1
II. OBJECTIVE
To study the effect of Ayurvedic formulation in controlling blood sugar level of the patients
suffering with Type-2 Diabetes mellitus.
III. CENTRE
Identified Centres of CCRAS
References
1. Harrison’s Principle of Internal Medicine 15th Edition Page 2109-2135.
2. The Expert Committee on the Diagnosis and classification of Diabetes Mellitus : Report of the
Expert Committee on Diagnosis Classification of Diabetes Mellitus, Diabetic care 1997;
207:1183-97.
3. Siddharth N Shah, Asshit Shah, API Text Book of Medicine 5th Edition Page-1460.
4. Vaisajya Ratnawali, Saptam Sanskaran 2040 Page 812.
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IV. SAMPLE SIZE AND METHODS
Sample Size-100
Total Number of group-Two
Total number of patients in each group-50
Level of study-OPD
Treatment:
A. Dietary regimen: Patient will be advised to restrict their dietary schedule and do
light exercises (like brisk walking for two kms. per day, swimming, jogging etc.
during treatment).
B. Trial drug:
1. Ayush-DIAB 500 mg dragees BD with water half hrs before meals (Capsule
Ayush-DIAB contained extracts of Meshashringi (leaves) one part+ Amra Beeja
Majja one part + Karvelaka Beeja one part + Jambu Beeja one part + Silajeeta
one part) for six months.
Diet: - Patients will be advised to take their diet as described in Patient information sheet
and do brisk walking/jogging or light exercise for half hour daily..
2. Standard control: Glimepiride 1mg OD ½ hour before meal.
Duration of the study: Six months (total duration of the study 2 years)
Duration of medication - Six months
Total duration of study – 2 years
V. CRITERIA FOR INCLUSION
1. Age between 30 years to 65 years
2. If yes in any of the three
Blood sugar – Fasting > 126 and =< 200 mg/dl or
PP > 200 mg/dl and <= 350 mg/dl or
Glycated haemoglobin > 7% and <10%
3. Recently diagnosed (< 6 Month) cases of Type-2 Diabetes mellitus not taking any anti
Diabetic drug.
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VI. CRITERIA FOR EXCLUSION
1. Age below 30 and above 65 years.
If yes in any of the three
Blood sugar – Fasting =< 126 and > than 200 mg/dl or
PP=< 200 mg/dl >350 mg/dl or
Glycated haemoglobin<=7% and =>10%
2. Malignant and accelerated hypertensive
3. CVS disorder (CAD)
4. Pregnant woman and planning to be pregnant within six months
5. Lactating mother
6. Secondary Diabetes mellitus
7. Patient under going regular treatment for Diabetes or any other severe illness
8. CNS disorder e.g. encephalopathy
VII. CRITERIA FOR WITHDRAWAL
The investigator shall withdraw the patients from the study if
1. Fasting blood sugar rises to >200 mg. /dl. Or post prandial blood sugar level increases
to>350 mg./dl and are not controllable within fifteen days.
2. Any serious complication develops which requires urgent treatment with any other drug/
therapy?
The investigator will mention the probable cause of withdrawal and provide possible
medical treatment to manage the illness.
VIII. ROUTINE EXAMINATION AND ASSESSMENT
The full details of history and physical examination of the patients will be recorded as per the
proformae (Forms I & IA). Clinical and physiological assessment will be done before drug
administration and after every two weeks. The laboratory investigations will be recorded before drug
administration, after every two weeks (blood Sugar only) and at the end of treatment (Form-III)
IX. CRITERIA FOR ASSESSMENT
If during treatment or after treatment fasting Blood sugar becomes<126 mg. /dl. and post
prandial Blood sugar< 200mg./dl. and HbA1c < 7% it will be treated as successful outcome of
the treatment.
461
X. STATISTICAL ANALYSIS
Data on Fasting/Post prandial blood sugar and HbA1c will be analyzed using appropriate
statistical methods.
XI. TRIAL MONITORING AND DATA ANALYSES
The progress of the trial will be monitored by CCRAS Hqrs. New Delhi consisting of one
expert each of allopathy and Ayurveda besides one outside expert. Data analysis will be
undertaken at the Monitoring Unit CCRAS Hqrs. New Delhi
XII. ETHICAL REVIEW
A. Ethical Committee (IEC): The proposal will be placed before Ethical Committee (IEC)
of trial center for getting clearance certificate before the project is initiated. Patient’s
information sheet and informed consent form will be submitted along with project proposal
for approval by EC. Both will be maintained in duplicate with one copy given to the
patient at the time of entry to the trial.
B. Data and safety monitoring board: A Data and safety monitoring board (DSMB) at
Hqrs. will carefully monitor the data and side effects during the period of study and put in
a place where by prompt reporting of adverse events occur. The data will be reviewed as
every 20 participants entered the study and administered the trial drugs. The research
team will report immediately to the PI and Data Monitoring Board if, any life threatening
conditions whether they are perceived to be study related or not. The Board decides
whether the adverse effects warrant discontinuation of the study protocol. Protocols will be
written and approved for the treatment of study related adverse events.
XIII. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
Short-term two-day training will be provided to the Investigators and Laboratory
personnel involved in the multi-centric trial at CCRAS Hqrs. The investigators and technicians will
be detailed about the clinical trial conduct and laboratory procedures in order to maintain the
uniformity.
XIV. LABORATORY INVESTIGATIONS
The Laboratory Investigations (Pathological/Biochemical, etc.), which are not available at
research Institutes should be conducted at identified reputed labs /Government Institutes under
intimation to this Council following codal formalities.
462
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
RANDOMISED DOUBLE BLIND CONTROLLED CLINICAL TRIAL OF
AYUSH-DIAB IN CONTROLLING BLOOD SUGAR LEVEL IN Type 2
DIABETES MELLITUS
CONSENT FORM
CERTIFICATE BY INVESTIGATOR
I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature of the Investigator: ___________
Name of Investigator: ________________
CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending physician, the purpose of the
clinical trial and the nature of drug treatment and follow-up, including the laboratory investigations
to be performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so.
I, exercising my free power of choice, hereby give my consent to be included as a subject
in the clinical trial on Randomized Controlled Clinical Trial of Ayush-DIAB Capsules in the
Controlling Blood Sugar Level in Type 2 Diabetes mellitus.
463
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
RANDOMISED DOUBLE BLIND CONTROLLED CLINICAL TRIAL OF
AYUSH-DIAB IN CONTROLLING BLOOD SUGAR LEVEL IN Type 2
DIABETES MELLITUS
PATIENT INFORMATION SHEET
464
Are there any risks?
Both trial and control drugs may cause hypoglycemia (very low blood sugar) in some
cases. The symptoms of hypoglycemia are sweating, drowsiness, nausea, confusion and in-
coordination. In case of such symptoms, you should immediately take sugar, glucose/biscuits and
milk/fresh lime juice/orange juice with sugar and report to the doctor.
What are the alternatives?
Your doctor will be pleased to explain to you the available alternative treatment to control
your blood sugar?
When you leave can the study?
Your participation in the study is entirely voluntary. You can choose to leave the study at
any time. Your decision to leave the study will not affect your medical care or relationship with
your doctor.
Your doctor may decided that you should not continue in the study if, a) your blood sugar
becomes very high or very low, b) you start on insulin or other medication that affect blood sugar,
c) you take part in any other trial.
What is the cost of the study?
All medication and tests to be done during the study will be free of charge.
If you do not want to participate, you are free to do so. It will not affect your medical
care or relationship with your doctor in any way.
What happens now if you decided to take part?
You will asked to sign a consent form saying that you have been given information about
the study and you voluntarily agree to take part.
It is important to follow all instruction given by your doctor or doctor’s assistant carefully.
DIET REGIMEN:
To take 25 cal/kg per day (Moderate work)
Protein 0.8 gm/kg per day
Total Fat < 30% of calories (Saturated fat < 10% polyunsaturated fat < 10% of calories)
Cholesterol < 300 mg per day
Dietary fibre 50 gm per day (atleast)
Common salt < 5 gm. per day
465
Saturated fat & cholesterol are found in e.g. Ghee, Vanaspati, Dalda, Palm, Coconut oil.
These contain highly saturated fat. Patient should be advised to take less saturated fat and
cholesterol.
Poly unsaturated fat take Sun flower oil, Soyabene oil, Olive oil which contained
unsaturated fat should be taken 3 small tea spoonful / day.
Milk : Three cup daily double tone
Whole Cereal: 90 gm daily. [old samarice, kodo, java, wheat with husk]
Vegetable : 250 gm daily [padwal, karaila, methi, pumpkin, brinjal, beans]
Dal : 400 ml. daily [Moong, Masoor, Kulthi, Arhar, Garam]
Fruits : 200 gm. Daily [Apple,Guava & Pappaya]
Spices : [Ginger,coriander,cardamom]
DO’NT
To avoid smoking.
To avoid Fasting.
To avoid sweets, honey, sugar, jaggery, cold drinks, fruit juice, avoids fruits e.g. Mango,
Sharifa, Grapes, Chiku, Banana, Khajur, potato,turnip & beetroot
466
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
RANDOMISED DOUBLE BLINDCONTROLLED CLINICAL TRIAL OF AYUSH-
DIAB IN CONTROLLING BLOOD SUGAR LEVEL IN Type 2 DIABETES
MELLITUS
CASE REPORT FORM I - SCREENING
1. Centre: ______________________________
4. Address : _______________________________________________________________
467
5. If yes in any of the three
9. Lactating mothers
If admitted:
468
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
RANDOMISED DOUBLE BLINDCONTROLLED CLINICAL TRIAL OF AYUSH-
DIAB IN CONTROLLING BLOOD SUGAR LEVEL IN Type 2 DIABETES
MELLITUS
CASE REPORT FORM II – HISTORY
1. Centre: ______________________________
5. Address : _______________________________________________________________
8. Educational status:
Christian 4 Parsi 5
469
Chief complaint with duration (if any) in days
16. Exhaustion/Tiredness
19. Giddiness
22. Others
Personal History
Addiction
470
28. Alcohol No 0 Yes 1
Sannipataj 7
Physical Examination
Systolic_________________(mm Hg)
38. CVS
39. CNS
471
40. Digestive system
472
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
RANDOMISED DOUBLE BLINDCONTROLLED CLINICAL TRIAL OF AYUSH-
DIAB IN CONTROLLING BLOOD SUGAR LEVEL IN Type 2 DIABETES
MELLITUS
CASE REPORT FORM III - CLINICAL & PHYSIOLOGICAL ASSESSMENT
[Before Treatment & Fortnightly During Treatment]
1. Centre: ______________________________
5. Address : _______________________________________________________________
8. Date of Assessment :
12. Exhaustion/Tiredness
13. Bodyache
14. Giddiness
473
16. Visual disturbance
17. Others
Physiological Assessment
474
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
RANDOMISED DOUBLE BLINDCONTROLLED CLINICAL TRIAL OF AYUSH-
DIAB IN CONTROLLING BLOOD SUGAR LEVEL IN Type 2 DIABETES
MELLITUS
CASE REPORT FORM IV- LABORATORY INVESTIGATION
1. Centre: ______________________________
5. Address : _______________________________________________________________
8. Date of Assessment :
Urine Examination
Routine
9. Sugar ____________
Microscopic
Stool examination
475
Microscopic
Blood
LIPID PROFILE
Serum Bilirubin
476
34. Direct (mg/dl) ____________
Serum Electrolytes
Sl.No.9 – 43 will be done before and after treatment except Sl.No. 23 (Blood Sugar) which
will be done before treatment and fortnightly during treatment period. HbA1c will be repeated
after three months also.
477
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478
EYE DISORDERS
SECTION - VII
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480
CLINICAL EVALUATION OF AYUSH-CT DROPS AND
AYUSH-CT CAPSULE IN IMPROVING THE QUALITY
OF VISION AND PREVENTION OF PROGRESS IN
SENILE IMMATURE CATARACT (LINGANASA)
481
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482
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF AYUSH-CT DROPS AND AYUSH-CT CAPSULE
IN IMPROVING THE QUALITY OF VISION AND PREVENTION OF
PROGRESS IN SENILE IMMATURE CATARACT (LINGANASA)
I. BACKGROUND
Senile cataract (Linganasa1) is a disease of common occurrence in all geographical areas
and in all races. The incidence, however, is distinctly more in tropical countries. The two factors
peculiar to tropical circumstances and responsible for this high incidence are higher concentration
of actinic rays in tropical sunlight, and the nutritional deficiency factors so significant in these areas.
It can be generally stated that in developing tropical countries, the age of 50 years and above is
considered a cataractogenous age and the degree of incidence increases as the age advances. It
is safe to assume that 60% people develop cataract by the age of 60 years. 70% by the age of
70 years, 80% by 80 years and 90% by 90 years of age. It was estimated that 55% of total or
partial blindness was due to cataract in some stage of its formation. Of these, the incidence in
rural areas was 70% and in Urban areas 30%. Similarly, the incidence in males was 64.4% as
compared to 35.6% in females. It is rare in persons under 50 and these disturbances occur in (a)
impaired semi permeability of the capsule, (b) increased insoluble proteins, and (c) less effective
auto-oxidative system.
The current lines of management include various surgical methods. There is no definite
medical treatment for this condition in the patients where surgical treatment is not suitable (like
uncontrolled diabetes, cardiac disorders and so on.) Ayurvedic literatures have recorded many
single drugs and compound formulations for the treatment of Linganasa/Timira. (Cataract) .Drugs
like Punarnava, Amalaki, Palasha etc. possess various pharmacological actions like Chakshushaya
(Improves visual acuity), Timira hara (Effective managing various disorders of vision) besides its
Rasayana action that prevents free radical damage i.e. anti-oxidant effect1.
II. OBJECTIVE
To evaluate the therapeutic efficacy of Ayush-CT Drops and Ayush-CT Capsule In
improving the quality of vision and Prevention of progress in senile immature cataract
References
1. Ambika Dutta Sashtri (1989) Susruta Samhita (text with Hindi commentary) Uttara Sthana, VIIth
Edition Chaukhamba Sanskrit Series Office, Varanasi.
2. Actions & uses of indigenous ophthalmic drugs, Chaukhamba Sanskrit Pratisthan, New Delhi
483
III. CENTRE
CCRAS identified centers
IV. SAMPLE SIZE AND METHODS
Sample size : 50 cases
Trial Drug /Dosage /Duration
1. Ayush-CT Drops {Distillate (Ark) of equal parts of Punarnava and
Palashamoola} two drops three times a day and Ayush-CT Capsule (Extract of
equal parts of Punarnava and Amalaki) 500mg. two capsules BD for 4months
2. Placebo- Distilled water two drops three times a day and glucose capsules 500mg.
two capsules BD for 4 months
Design of the study : Double blind Randomized controlled trial
Duration : Four months drug therapy with a follow up for two months
without drug.
Period of Study : Six months (Four months drug therapy and two months
follow-up) for each case. Total duration will be two years
to complete the trial.
Follow – Up : One follow-up will be carried out after two months of the
completion of treatment.
V. CRITERIA FOR INCLUSION
1. Age above 50 years and up to to 80 years
2. Both the sex
3. Immature cataract (confirmed by ophthalmoscopy, retinoscopy/iris shadow presence)
With any one or both of the symptoms
• Disturbance in vision (diplopia,polyopia,holes etc)
• Diminished visual acuity
VI. CRITERIA FOR EXCLUSION
1. Age below 50and above80 years
2. Mature cataract
3. Sluggish pupil reaction
484
4. Hypertension
5. Diabetes mellitus
6. Glaucoma
7. Any other illness causing notable visual morbidity
8. Person undergoing treatment for any other serious illness
VII. CRITERIA FOR WITHDRAWAL
During the course of the trial treatment, if any serious condition develops/ symptoms
aggravates, which requires urgent treatment, such subjects may be withdrawn from the trial and
managed by the Principal Investigator accordingly.
VIII. ROUTINE EXAMINATION AND ASSESSMENT
The full details of history and physical examination of the patients will be recorded as per
the proforma (Forms I & IA). Clinical assessment will be done during treatment (Form II). The
laboratory investigations will be carried out before and after the treatment.
IX. STATISTICAL ANALYSIS
Data on disturbance in vision and diminished visual acuity will be analyzed using
appropriate statistical methods.
Improvement in visual acuity (Using near vision and distance vision chart-Snellen’s test
type) and disappearance of symptoms of disturbances in vision (Clinical assessment) will be
considered as significant, besides status of cataract examined through ophthalmoscopy, retinoscopy
and Iris shadow tests.
X. TRIAL MONITORING AND DATA ANALYSIS
The progress of the trial will be monitored by CCRAS HQrs. New Delhi. Data analysis
will be undertaken at the Monitoring Unit CCRAS HQrs. New Delhi
XI. ETHICAL REVIEW
A. Ethical Committee (IEC): The proposal will be placed before Ethical Committee (IEC)
of trial center for getting clearance certificate before the project is initiated. Patient’s
information sheet and informed consent form will be submitted along with project proposal
for approval by EC. Both will be maintained in duplicate with one copy given to the
patient at the time of entry to the trial.
B. Data and safety monitoring board: A Data and safety monitoring board (DSMB) at
Hqrs. will carefully monitor the data and side effects during the period of study and put in
a place where by prompt reporting of adverse events occur. The data will be reviewed as
485
every 20 participants entered the study and administered the trial drugs. The research team
will report immediately to the PI and Data Monitoring Board if, any life threatening
conditions whether they are perceived to be study related or not. The Board decides
whether the adverse effects warrant discontinuation of the study protocol. Protocols will be
written and approved for the treatment of study related adverse events.
XII. TRAVELING EXPENSES FOR RESEARCH SUBJECTS
A consolidated amount of Rs.……. /- per visit will be paid to subjects
selected.
XIII. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
Short-term two-day training will be provided to the Investigators and Laboratory
personnel involved in the multi-centric trial at CCRAS Hqrs. and Central Research Institute (Ay.),
New Delhi. The investigators and technicians will be detailed about the clinical trial conduct and
laboratory procedures in order to maintain the uniformity.
XIV. LABORATORY INVESTIGATIONS
The Laboratory Investigations (Pathological/Biochemical, etc.), which are not available at
research Institutes should be conducted at identified reputed labs /Government Institutes under
intimation to this Council following codal formalities.
486
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF AYUSH-CT DROPS AND AYUSH-CT CAPSULE
IN IMPROVING THE QUALITY OF VISION AND PREVENTION OF
PROGRESS IN SENILE IMMATURE CATARACT (LINGANASA)
CONSENT FORM
CERTIFICATE BY INVESTIGATOR
I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature of the subject: ______________
Name: ____________________________
CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending physician, the purpose of the
clinical trial and the nature of drug treatment and follow-up, including the laboratory investigations
to be performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so.
I, exercising my free power of choice, hereby give my consent to be included as a subject
in the trial on “Clinical Evaluation Of Ayush-CT Drops And Ayush-CT Capsule In improving the
quality of vision and Prevention Of Progress in senile immature cataract”
487
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF AYUSH-CT DROPS AND AYUSH-CT CAPSULE
IN IMPROVING THE QUALITY OF VISION AND PREVENTION OF
PROGRESS IN SENILE IMMATURE CATARACT (LINGANASA)
PATIENT INFORMATION SHEET
488
At each visit, you will be supplied with sufficient quantities of drugs to last until
your next visit. If any adverse reactions like skin allergy, nausea, vomiting and
palpitation/tremor etc., noticed during the treatment period, this should be informed to the
Principle Investigator.
489
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF AYUSH-CT DROPS AND AYUSH-CT CAPSULE
IN IMPROVING THE QUALITY OF VISION AND PREVENTION OF
PROGRESS IN SENILE IMMATURE CATARACT (LINGANASA)
CASE REPORT FORM I – SCREENING
BEFORE TREATMENT
(Enter a in the appropriate box)
1. Centre: ______________________________
5. Address : _______________________________________________________________
6. Mature cataract.
490
8. Diabetes mellitus
9. Glaucoma
10. Hypertension
491
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF AYUSH-CT DROPS AND AYUSH-CT CAPSULE
IN IMPROVING THE QUALITY OF VISION AND PREVENTION OF
PROGRESS IN SENILE IMMATURE CATARACT (LINGANASA)
CASE REPORT FORM II- HISTORY
(Enter a in the appropriate box)
1. Centre: ______________________________
4. Address : _______________________________________________________________
7. Educational status:
492
11. Diplopia
12. Polyopia
13. Holes
Distant vision:
Near vision:
493
23. Prakriti Vata 1 Pitta 2 Kapha 3
Sannipataja 7
30. Opacity
31. Size
32. Direct
33. Consensual
Distant vision:
494
35. Right Eye ___________
Near vision:
Glasses (Correction)
Tonometry (Schitoz’s)
Intraocular pressure*
* 6-21 Normal
495
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF AYUSH-CT DROPS AND AYUSH-CT CAPSULE
IN IMPROVING THE QUALITY OF VISION AND PREVENTION OF
PROGRESS IN SENILE IMMATURE CATARACT (LINGANASA)
CASE REPORT FORM III - CLINICAL ASSESSMENT
(0, end of 1st, 2nd, 3rd, 4th, 5th & 6th month)
(Enter a in the appropriate box)
1. Centre: ______________________________
4. Address : _______________________________________________________________
7. Disturbance in vision
8. Diplopia
9. Polyopia
10. Holes
If Present, Specify___________________________
Distant vision:
496
14. Both Eyes ___________
Near vision:
Continuing (1)
497
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF AYUSH-CT DROPS AND AYUSH-CT CAPSULE
IN IMPROVING THE QUALITY OF VISION AND PREVENTION OF
PROGRESS IN SENILE IMMATURE CATARACT (LINGANASA)
CASE REPORT FORM IV – LABORATORY INVESTIGATIONS AND
PHYSIOLOGICAL PARAMETERS
(Before the treatment)
1. Centre: ______________________________
4. Address : _______________________________________________________________
7. Date of Assessment :
498
CLINICAL EVALUATION OF THE EFFECT OF
TARPANA AYUSH-DE EYE DROPS, AYUSH-DE
CAPSULES IN THE MANAGEMENT OF DRY EYE
SYNDROME (SHUSHKAKSHIPAKA/PARISHUSKHA
NETRA)
499
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500
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF THE EFFECT OF TARPANA AYUSH-DE EYE
DROPS, AYUSH-DE CAPSULES IN THE MANAGEMENT OF DRY EYE
SYNDROME (SHUSHKAKSHIPAKA / PARISHUSHKA NETRA)
I. BACKGROUND
In certain conditions, there is insufficiency of lubrication of eye and the conjunctiva
becomes dry. Deficiency in any components of tear film, results in dryness of the eye, due to the
appearance of dry spots on the corneal and conjunctival epithelium. Sushruta considered
shushkakshipaka as an individual disease and classified under sarvagata netra rogas. Even though
there is no separate entity such as Parishushka netra in classics, authors of different texts
mentioned the above condition while describing the therapeutic procedure adapted for the
management of eye disease. Conditions like Ativishushka netra, Ashrusrava rahita netra,
Asnigdha netra are mentioned in Nibandha samgraha (one of the commentaries on Sushruta
Samhita.)
There are many conditions which cause dryness of the eyes. Hypofunction of lacrimal
glands (eg. sjogren’s syndrome, sarcoidosis, lymphoma, leukemia amyloidosis.), mucin deficiency
(e.g. vitamin A deficiency), conjunctival scarring, (e.g. trachoma, Stevans Johnson syndrome,
pemphigold, chemical burns, chronic bacterial or viral conjunctivitis, irradiation and miscellaneous
causes such as mumps, deficient blinking etc.).
(Kapha is responsible for sanigdhatwa (oiliness) sthiratwa (structrual and functional integrity
of body systems) by means of its qualities like gurutwa and shitatwa.) Tarpaka kapha, one of the
five varieties of Kapha, situated in siras is responsible for the integrity of sense organs
(akshitarpana). According to Dalhana, the term aksha refers to sense organs like netra. Collective
function tear film components can be correlated with the function of the tarpakakapha.
Clinical studies conducted with topical and internal use of Ghrita prepared with the Haridra
and Daruharidra has shown significant improvement in subjective parameters like Dryness,
Redness, Photophobia etc. Pharmacological actions such as chaksushya (conducive to vision),
netrya (conducive to eye), netra ruja hara (analgesic ophthalmic action) are attributed to haridra,
daruharidra and ghrita from which the formulation under taken for the study was prepared. The
response obtained after the clinical study could be well understood with the above
pharmacological actions ascribed to various ingredients 1&2
References
1. Dry Eye Syndrome and its management – A clinical study, JRAS, Vol.XXII, No.1-2, (2001)
pp.17-24.
2. Actions & uses of indigenous ophthalmic drugs, Chaukhamba Sanskrit Pratisthan, New Delhi.
3. Sushruta Uttarasthana Chapter 9/18-22
501
II. OBJECTIVE
To evaluate the effect of Ayush-DE drops and Akshi tarpana in dry eye syndrome
(shushkakshipaka / parishuskha netra)
III. CENTRE
CCRAS identified Centres
IV. SAMPLE SIZE AND METHODS
No. of groups : Four groups
No of patients in each group : 25
Type of Study : Open
Level of Study : OPD/IPD
Period of Study : 4 months (3 months treatment and one
month follow up Study with Distilled
Water)
Treatment:
Group-I
1. Akshi Tarpana with Ayush-DE Ghrita {prepared with equal parts of Yashtimadhu
(Glycerrhiza glabra)} for five days.
2. Installation of Ayush-DE drops {Yashtimadhu (Glycirrhiza glabra)} three drops
three times a day for three months.
Group-II
Installation of Ayush-DE drops {prepared with Yashtimadhu (Glycirrhiza glabra)} three
drops three times a day for three months.
Group-III
Artificial tears for three months (conventional)
Group IV
Autoserum (optional)
Procedure of tarpana
Local application of tila taila around the eye orbit followed by mild sudation will be given
as purvakarma. Concentric boundary should be made around each orbit with paste of masha
choorna (Powder of Phaseolus mungo). 20 ml of lukewarm medicated ghee should be filled and
allowed to retain in the boundary for twenty minutes. After the prescribed period, ghrita will be
removed with cotton pads followed by removal of the boundary.
502
V. CRITERIA FOR INCLUSION
1. Dryness of the Eye with or without
a) Sandy and scratchy feeling
b) Pain / pricking sensation
c) Photophobia
d) Mild reddness/ Mild blepharitis
e) Less flow of tears even when exposed to irritant odour and fumes
f) Foreign body sensation
g) Mild reddness
2. Age between 20-40 years
3. Tear film break-up time less than 10 seconds
4. Rose Bengal staining showing devitalized epithelium of conjunctiva and mucus plaques on
the cornea.
5. Schimers tests positive < 10 mm (exact measurement)
6. Chronicity upto six months.
VI. CRITERIA FOR EXCLUSION
1. Age below 20 years above 40 years
2. Chronicity above 6 months.
3. Corneal ulcer
4. Degenerative condition of conjunctiva
5. Extra ocular and intra ocular infections
6. Contact Lens users
7. Systemic disease causing Dry Eye Syndrome (Physicians remarks)
VII. CRITERIA FOR WITHDRAWAL
During the course of the trial treatment, if any serious condition develops/ symptoms
aggravate, which requires urgent treatment, such subjects may be withdrawn from the trial and
managed by the Principal Investigator accordingly.
VIII. ROUTINE EXAMINATION AND ASSESSMENT
The full details of history including any associated diseases and physical examination of the
patients will be recorded as per the Proforma (Forms I & II). Clinical assessment will be done
503
before drug administration on every 15th day during the treatment and at the end of 3rd month
during follow up (Form III). Required laboratory investigations will be carried out to exclude
cases as specified in the criteria for exclusion. (Form-IV)
IX. CRITERIA FOR ASSESSMENT
Relief in subjective parameters viz. dryness, pain, redness, foreign body sensation and
improvement in tear film breakup time, Schimers tests will be considered as significant response.
X. STATISTICAL ANALYSIS
Data on clinical symptoms and objective tests before and after the treatment will be
tabulated and analyzed using appropriate statistical tools. However, the data of each case will have
to be communicated on completion of trial therapy to the Statistical Officer of CCRAS through e-
mail.
XI. TRIAL MONITORING AND DATA ANALYSIS
The progress of the trial will be monitored by CCRAS HQrs. New Delhi. Data analysis
will be undertaken at the Monitoring Unit CCRAS HQrs. New Delhi
XII. ETHICAL REVIEW
Each Institutional Ethical Committee (IEC) of participating centre’s should give
clearance certificate before the project is initiated. Patient’s information sheet and
informed consent form should be submitted alongwith project proposal for approval by
IEC. Both should be maintained in duplicate with one copy given to the patient at the
time of entry to the trial.
XIII. TRAVELLING EXPENSES FOR RESEARCH SUBJECTS
A consolidated amount of Rs.------/ per visit i.e., on the 1st day of recruitment after
screening, 15th, 30th, 45th, 60th day & end of 3rd month (6 times)
XIV. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
Short-term two-day training will be provided to the Investigators and Laboratory
personnel involved in the multi-centric trial at CCRAS Hqrs. and Central Research Institute (Ay.),
New Delhi. The investigators and technicians will be detailed about the clinical trial conduct and
laboratory procedures in order to maintain the uniformity.
XV. LABORATORY INVESTIGATIONS
The Laboratory Investigations (Pathological/Biochemical, etc.), which are not available at
research Institutes should be conducted at identified reputed labs /Government Institutes under
intimation to this Council following codal formalities.
504
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUAT ION OF THE EFFECT OF TARPANA AYUSH-DE EYE
DROPS, AYUSH-DE CAPSULES IN THE MANAGEMENT OF DRY EYE
SYNDROME (SHUSHKAKSHIPAKA / PARISHUSHKA NETRA)
CONSENT FORM
CERTIFICATE BY INVESTIGATOR
I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature of the subject: ______________
Name: ____________________________
CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending physician, the purpose of the
clinical trial and the nature of drug treatment and follow-up, including the laboratory investigations
to be performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so.
I, exercising my free power of choice, hereby give my consent to be included as a subject
in the “Clinical evaluation of the effect of tarpana and eye drops in the management of dry eye
syndrome (shushkakshipaka / parishushka netra)”
505
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUAT ION OF THE EFFECT OF TARPANA AYUSH-DE EYE
DROPS IN THE MANAGEMENT OF DRY EYE SYNDROME
(SHUSHKAKSHIPAKA / PARISHUSHKA NETRA)
PATIENT INFORMATION SHEET
506
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUAT ION OF THE EFFECT OF TARPANA AYUSH-DE EYE
DROPS IN THE MANAGEMENT OF DRY EYE SYNDROME
(SHUSHKAKSHIPAKA / PARISHUSHKA NETRA)
CASE REPORT FORM – 1 SCREENING
BEFORE TREATMENT
(Enter a in the appropriate box)
2. Centre : ...................................
4. Patient No.
Third 3 Fourth 4
4. Photophobia
8. Mild redness
507
10. Tear film break-up time
If Sl. No. 1-13 is ‘Yes’ and Sl. No. 14-19 are ‘No’
508
COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUAT ION OF THE EFFECT OF TARPANA AYUSH-DE EYE
DROPS, AYUSH-DE CAPSULES IN THE MANAGEMENT OF DRY EYE
SYNDROME (SHUSHKAKSHIPAKA / PARISHUSHKA NETRA)
CASE REPORT FORM -II HISTORY
(Enter a in the appropriate box)
2. Address : ..............................................................................................................................
4. Centre : ...................................
6. Patient No.
Third 3 Fourth 4
8. Educational status:
1. Environment : __________________
509
Chief complaint with duration (in month)
12. Photophobia
PERSONAL HISTORY
Sannipataja 7
510
SYSTEMIC EXAMINATION:
Normal Abnormal
Vision examination
Normal Abnormal
If abnormal, specify_______________________________________________________
Movement
Normal Abnormal
If abnormal, specify_______________________________________________________
(ashruyantra)
Conjunctiva (bulbar)
Conjunctiva (tarsal)
511
Sclera (Sukla mandala)
Reduced 3
512
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUAT ION OF THE EFFECT OF TARPANA AYUSH-DE EYE
DROPS, AYUSH-DE CAPSULES IN THE MANAGEMENT OF DRY EYE
SYNDROME (SHUSHKAKSHIPAKA / PARISHUSHKA NETRA)
CASE REPORT FORM III - CLINICAL ASSESSMENT
(0 day, 15th, 30th, 45th, 60th, days & end of 3rd month)
(Enter a in the appropriate box)
1. Centre: ______________________________
4. Address : _______________________________________________________________
513
Clinical Tests
Reason: ____________________________________________
514
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUAT ION OF THE EFFECT OF TARPANA AYUSH-DE EYE
DROPS, AYUSH-DE CAPSULES IN THE MANAGEMENT OF DRY EYE
SYNDROME (SHUSHKAKSHIPAKA / PARISHUSHKA NETRA)
CASE REPORT FORM IV – LABORATORY INVESTIGATIONS AND
PHYSIOLOGICAL PARAMETERS
(Sl.No.5 to 17will be done at 0 & 15th day and 18-20 at the end of 1st, 2nd month,
3rd and 4d month)
1. Centre: ______________________________
4. Address : _______________________________________________________________
7. Date of Assessment :
9. DLC: P (%) _______ L (%) _______ E (%) _______ M (%) _______ B (%) _______
9. Hb (g/dl): ___________________
515
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516
CLINICAL EVALUATION OF AYUSH –AC EYE DROPS
IN SIMPLE ALLERGIC CONJUNCTIVITIS
(KAPHAJA ABHISHYANDA)
517
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518
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF AYUSH –AC EYE DROPS IN SIMPLE
ALLERGIC CONJUNCTIVITIS (KAPHAJA ABHISHYANDA)
I. BACKGROUND
Allergic conjunctivitis1 is commonly occurring ocular problem in day-to-day ophthalmic
practice. Apart from phlyctenular conjunctivitis as a manifestation of endogenous allergy and spring
catarrh an exogenous allergy, the conjunctiva may react to many other sensitizing factors viz.
external, physical or chemical. Allergy as a cause of conjuctival congestion has however been
exaggerated. (Anything which does not fall into the description of a specific condition and any
condition show aetiology is undermined is often attributed to allergy.) This evasive diagnosis is
further supported by the favorable response of the conjuctival congestion to steroids (Dhanda et
al. 996).
Current line of management advocates the use of topical steroids/ decongestant drops/
Mast Cell Stabilizers along with anti-histamine agents, is found unsatisfactory and temporary,
should be repeated only during exacerbations, besides their adverse effects (Anonymous, 1996).
At this juncture it becomes essential to explore safe effective drug which could effectively tackle
such conditions. Ayurvedic literatures have recorded more than 60 plant drugs useful in the
treatment of various eye disorders. Daruharidra (Berberis aristata DC.), one of such agents has
potent anti-inflammatory and anti-allergic action.
[Netrarujahara (Analgesic ophthalmic action), Netrakanduhara (anti-allergic action),
Kaphajabhisyandahara (Effective in allergic ocular conditions) (SrikanthN.2000).] Berberine, an
alkaloid isolated from B. aristata and its salt berberine hydrochloride produced depressant effect
on histamine, 5-HT and Bradykinin. It exhibited anti-inflammatory property on acute, sub-acute
and chronic models of inflammation. Clinical application of berberine in chronic trachoma patients
by intraconjuctival injection proved highly effective. The effect confirmed by scientific studies, that
revealed “Berberine may prove practical remedy for large scale use in trachoma patients. Berberine
in a dose of 0.5 mg per egg protected 50-75% chick embryos from the lethal effect of the
trachoma organisms inoculated into the yolk sac”. The results supported the ancient Ayurvedic
claims on the use of the plant B. aristata in eye diseases and clinical report on the efficiency of
berberine in trachoma. (Bhatnar1970, Halder 1970,Imaz 1977, Verma. RL.1993, Anonymous
References
1. Ambika Dutta Sashtri (1989) Sushruta samhita (text with Hindi commentary) Uttara Sthana, VIIth
Edition Chaukhamba Sanskrit Series Office, Varanasi.
2. Actions & uses of indigenous ophthalmic drugs, Chaukhamba Sanskrit Pratisthan, New Delhi
519
1996) it may be concluded that the decoction of the Daruharidra may be successfully employed
in the management of acute and chronic conjunctivitis of varied aetiology.
A clinical study of 52 cases of Allergic conjunctivitis was conducted to evaluate the effect
of a potent Anti- inflammatory, and Anti- Allergic Indigenous Ophthalmic Drug -Daruharidra
(Berberis aristata DC.). Topical administration (Aschyotana) with decoction of root bark of
Daruharidra (Berberis aristata DC.) was scheduled for 5 days and Aschyotana procedure was
repeated for the same period at an interval of 7days.Follow up observation was done for one
month. This study reveled that the scheduled therapy is highly valuable in the management of
allergic conjunctivitis of varied aetiology. The response obtained may be explained with the anti-
allergic, anti-inflammatory, antibacterial, properties attributed to the drug (Bhatnar1970, Halder
1970, Imaz 1977, Sabir 1976, Verma. RL. 1993, Anonymous 1996) besides its Netrarujahara
(Analgesic Ophthalmic action), Kaphajabhisyandahara (effective in allergic ocular conditions), and
Netrya (Conducive to Eye) actions.
II. OBJECTIVE
To evaluate the effect of Ayush –AC eye drops in simple Allergic Conjunctivitis (Kaphaja
Abhishyanda)
III. CENTRE
Central Research Institute (Ay.), New Delhi
IV. SAMPLE SIZE AND METHODS
Sample Size _ 90 patients (2 Groups)
Design of the study – Randomized Control Trial
Trial Drug /Dosage /Duration
Ayush-AC Eye Drops {containing equal parts of Daruharidra (Berberis aristata) and
Sirisha (Albizia libeck)} three times a day for 15 days.
Control - Distil water + preservative used in the drug
Duration of the study - 1½ months including 15 days drug therapy with
a follow up for one month without drug.
Period of Study - 15 days for each case. Total duration will be one
year to complete the trial.
Follow – up - One follow-up will be carried out after one week of
the completion of treatment.
V. CRITERIA FOR INCLUSION
1. Patients presenting with cardinal features of allergic conjunctivitis viz.
• Redness
520
• Itching
• Lacrimation
• Irritation
• Photophobia.
2. Age >10 yrs.
3. Conjunctival smear negative for bacterial/viral (optional)/fungal infection.
VI. CRITERIA FOR EXCLUSION
1. Age below 10 yrs
2. Conjunctival smear showing evidence of infection.
Clinically diagnosed cases of
3. Infective conjunctivitis
4. Parasitic infestation
5. Contact Lens users
VII. CRITERIA FOR WITHDRAWAL
During the course of the trial treatment, if any serious condition develops/ symptoms
aggravates, which requires urgent treatment, if no response after one week of treatment such
subjects may be withdrawn from the trial and managed by the Principal Investigator accordingly.
VIII. ROUTINE EXAMINATION AND ASSESSMENT
The full details of history and physical examination of the patients will be recorded as per
the proforma (Forms I & II). Clinical assessment will be done before drug administration on 15th
day during drug therapy and 30th day & 45th during follow up (Form III). Required laboratory
investigations i.e. Stool examination (3 samples), TC (Cells/Cmm.), DC (P, L, E, M and B),
Absolute eosinophil, Hb% (g/dl), ESR (1st hour.) (mm), Blood Sugar – random (mg./dl,
Conjunctival swab for light microscopy and C&S evaluation will be carried out to exclude cases
as specified in the criteria for exclusion. (Form-III)
IX. CRITERA FOR ASSESSMENT
Disappearance of Redness, Itching, Lacrimation, Irritation and Photophobia will be
consider ed as significant out come of the treatment.
X. STATISTICAL ANALYSIS
Data on clinical symptoms and objective tests before and after the treatment will be
tabulated and analyzed using appropriate statistical tools. However, the data of each case will have
to be communicated on completion of trial therapy to the Statistical Officer of CCRAS through
e-mail.
521
XI. TRIAL MONITORING AND DATA ANALYSIS:
CCRAS, Hqrs, New Delhi will undertake the monitoring of progress of the trial and data
analysis.
XII. ETHICAL REVIEW:
A. Ethical Committee (IEC): The proposal will be placed before Ethical Committee (IEC)
of trial center for getting clearance certificate before the project is initiated. Patient’s
information sheet and informed consent form will be submitted along with project proposal
for approval by EC. Both will be maintained in duplicate with one copy given to the
patient at the time of entry to the trial.
B. Data and safety monitoring board: A Data and safety monitoring board (DSMB) at
Hqrs. will carefully monitor the data and side effects during the period of study and put in
a place where by prompt reporting of adverse events occur. The data will be reviewed as
every 20 participants entered the study and administered the trial drugs. The research
team will report immediately to the PI and Data Monitoring Board if, any life threatening
conditions whether they are perceived to be study related or not. The Board decides
whether the adverse effects warrant discontinuation of the study protocol. Protocols will be
written and approved for the treatment of study related adverse events.
XIII. TRAVELING EXPENSES FOR RESEARCH SUBJECTS
A consolidated amount of Rs. ______/- per visit.
XIV. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
Short-term two-day training will be provided to the Investigators and Laboratory
personnel involved in the multi-centric trial at CCRAS Hqrs. and Central Research Institute (Ay.),
New Delhi. The investigators and technicians will be detailed about the clinical trial conduct and
laboratory procedures in order to maintain the uniformity.
XV. LABORATORY INVESTIGATIONS
The Laboratory Investigations (Pathological/Biochemical, etc.), which are not available at
research Institutes should be conducted at identified reputed labs /Government Institutes under
intimation to this Council following codal formalities.
522
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
PROTOCOL FOR CLINICAL EVALUATION OF AYUSH –AC EYE DROPS IN
SIMPLE ALLERGIC CONJUNCTIVITIS (KAPHAJA ABHISHYANDA)
WRITTEN INFORMED CONSENT FORM
CERTIFICATE BY INVESTIGATOR
I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature of the subject: ______________
Name: ____________________________
CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending physician, the purpose of the
clinical trial and the nature of drug treatment and follow-up, including the laboratory investigations
to be performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so.
I, exercising my free power of choice, hereby give my consent to be included as a subject
in the “Clinical Evaluation of Ayush –AC Eye Drops in simple Allergic Conjunctivitis (Kaphaja
Abshyanda)”
523
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
PROTOCOL FOR CLINICAL EVALUATION OF AYUSH –AC EYE DROPS IN
SIMPLE ALLERGIC CONJUNCTIVITIS (KAPHAJA ABHISHYANDA)
PATIENT INFORMATION SHEET
524
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUAT ION OF THE EFFECT OF TARPANA AYUSH-DE EYE
DROPS, AYUSH-DE CAPSULES IN THE MANAGEMENT OF DRY EYE
SYNDROME (SHUSHKAKSHIPAKA / PARISHUSKHA NETRA)
CASE REPORT FORM – 1 SCREENING
BEFORE TREATMENT
(Enter a in the appropriate box)
1. Centre : ...................................
5. Address : ..............................................................................................................................
• Redness,
• Itching,
• Lacrimation,
• Irritation
• Photophobia.
525
5. Conjunctival smear showing evidence of infection.
6. Infective conjunctivitis
7. Parasitic infestation
526
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
PROTOCOL FOR CLINICAL EVALUATION OF AYUSH –AC EYE DROPS IN
SIMPLE ALLERGIC CONJUNCTIVITIS (KAPHAJA ABHISHYANDA)
Case Report form-II history
(Enter a in the appropriate box)
1. Centre : ...................................
4. Patient No.
6. Address : ..............................................................................................................................
7. Educational status:
527
Chief complaint with duration (in month)
11. Redness
12. Itching
13. Photophobia
14. Lacrimation
15. Irritation
If yes, Specify____________________________________________________________
Fish-veg 4
528
20. Sharirik Prakriti: Vata 1 Pitta 2 Kapha 3
Sannipataja 7
Sama 7
I. Vision
IV.Lids (Vartma)
(d) Lashes
Scantiness Yes 1 No 2
(e) Lidmargin
Ectropion Yes 1 No 2
Entropian Yes 1 No 2
529
VI. Conjunctiva (bulbar) Yes (1) No (2)
Congestion
Conjunctival/CCC
Oedema
Hemorrhage
Redness
Nodule
Others Yes
Change in colour
Pigmentation
Nodule Yes
Congestion
(a) Opacity
(b) Oedema
(c) Vascularisation
(e) Keratitis
X. Anterior Chamber
530
XI. Iris (Mamsa ashrita patala)
XII. Vitreous
531
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
PROTOCOL FOR CLINICAL EVALUATION OF AYUSH –AC EYE DROPS IN
SIMPLE ALLERGIC CONJUNCTIVITIS (KAPHAJA ABHISHYANDA)
CASE REPORT FORM III - CLINICAL ASSESSMENT
1. Centre: ______________________________
4. Address : _______________________________________________________________
If yes, details____________________________________________________________
Continuing (1)
532
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
PROTOCOL FOR CLINICAL EVALUATION OF AYUSH – AC EYE DROPS IN
SIMPLE ALLERGIC CONJUNCTIVITIS (KAPHAJA ABHISHYANDA)
CASE REPPOT FORM IV – LABORATORY INVESTIGATIONS
(Before treatment)
1. Centre: ______________________________
4. Address : _______________________________________________________________
7. Date of Assessment :
8. Stool examination
9. TC (Cells/Cmm.)_____________________
533
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534
CONNECTIVE TISSUE DISORDER
SECTION - VIII
Blank
536
CLINICAL TRIAL ON EVALUATION OF EFFECT OF
JALAUKAVACHARANA IN DEEP VEIN THROMBOSIS
537
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538
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL TRIAL ON EVALUATION OF EFFECT OF JALAUKAVACHARANA
IN DEEP VEIN THROMBOSIS
I. BACKGROUND
Presence of thrombosis1 within a deep vein and accompanying inflammatory response in
the vessel wall is termed as thrombosis of deep vein. Most important consequences of deep vein
thrombosis is pulmonary embolism. More than 90% of pulmonary embolism arise from deep vein
thrombosis (William F.; Baker Jr., 1998) Pulmonary embolism has mortality of 18.3% without
treatment (Kemp PM, Traror D Batty V. et.al., 1996). Once the deep vein thrombosis occurs,
the risk of pulmonary embolism is high in first 72 hrs.
Risk factors for Deep Vein Thrombosis: Virchow triad of venous stasis, intimal injury and
hypercoagulable state was described in 1856 but still hold some truth.Extensive autopsy and clinical
studies have shown that 95% pulmonary embolism arise from deep vein thrombosis in the lower
limbs. Indwelling catheter in upper extremity veins like superior vena cava and right ventricle can
induce thrombosis.
Prevention of pulmonary embolism is the most important aim of treating the patient with
deep vein thrombosis. Prophylaxis is achieved by drug like heparin, LMW heparin or oral
anticoagulant and physical method like intermittent leg compression and graduated compression
stocking. In the early phase thrombolytic maybe useful in clot lysis.
Due to high cost of thrombolytics and LMW Heparin and bleeding and thrombo-
cytopenic side effect of heparin, the future Ayurvedic procedure Jalaukavacharana (leech
application) which has low cost and no side effect hold a strong promise for development of a
better procedure. Previous studies showed Jaloukavacharana as a promising treatment for deep
vein thrombosis. The same needs to be verified further.
II. OBJECTIVE
To evaluate the effect of Jalaukavacharana (leech application) in deep vein thrombosis.
References
1. Harisson’s Principles of internal medicine, 14th Edition, International Editions, 1998, Published
by McGraw-Hill CompaniesInc.pp1652
539
III. CENTRES
CCRAS identified centers
IV. SAMPLE SIZE AND METHODS
Sample size : 20 in each centre
Procedures of leech application:
1. Pre-operative procedure:
i Preparation of leech: Before using for blood letting, the leeches should be
purified by keeping them in water mixed with turmeric powder for some
time. Then, they should be shifted to the fresh water.
ii Preparation of patient: Thoroughly examined patient should be made to
take comfortable and convenient lying down position. The part of the
body where leech is to be applied should be cleanly washed and dried by
wiping with cotton cloth or swab. Antiseptic lotion or oil etc. should not be
used.
2. Operative procedure:
Then one or two leeches depending on the condition should be applied to the
swollen and indurated part of the limb. If the leech does not suck the blood, a drop of
milk or blood should be; put on the site. Still if leech fails to such the blood, mild prick
should be made on the skin. After the leech starts sucking the blood, it should be covered
with a wet cloth. If at biting site, pricking pain and itching appears, the leech should be
removed, if it does not leave, its mouth should be sprinkled with the turmeric powder.
3. Post operative procedure:
i Care of patient: After detachment of the leech, bleeding may continue. At
that time turmeric powder should be applied on the bleeding spot and
washed with cold water and dried by gently pressing with a gauze. Then
to enhance the healing process, Jatyadi Taila should be applied and
bandaged.
ii Care of leech: In order to make the leech fit for further use, it should be
made to vomit the sucked blood, by keeping it in the water mixed with
turmeric powder followed by holding it upside down and applying mild
pressure on the body of the leech from tail to mouth. After complete
vomiting it should be washed out with cold water and kept in the pot.
After 7 days, we can make use of the same leech for blood letting.
540
Duration of the Procedure- Application of leech will be done twice a week with an
interval of 3 days. Total duration of the procedure is 1 month.
Design of the study – Open Trial
Total period of study- 12 months
V. CRITERIA FOR INCLUSION
1. Both sexes
2. Between 25 years and 70 years.
3. Unilateral swelling of lower limb
4. Warmth and erythema over swelling
5. Tenderness over swelling
6. Calf pain (Posterior calf tenderness)
7. History of Immobilization for more than 2 weeks
8. Post menopausal hormonal replacement therapy
9. Patient with hemodynamically stable
10. Patient with positive finding of thrombosis on the basis of intravascular Doppler Study
VI. CRITERIA FOR EXCLUSION
1. Patient with hamodynamically unstable
2. Patient with Bleeding disorder
3. Patient with Respiratory failure
4. Severe CCF with EF < 30%
5. Severe uncontrolled diabetes
6. Acute MI
7. History of recent haemorrhagic stroke
8. Person undergoing treatment for any other serious illness
VII. CRITERIA FOR WITHDRAWAL
During the course of trial treatment, if any serious condition develops which requires
urgent treatment; such subjects may be withdrawn from the trial and managed by the Principal
Investigator accordingly.
541
VIII. ROUTINE EXAMINATION AND ASSESSMENT
The full details of history and physical examination of the patients will be recorded as per
the proforma (Forms I & II). Clinical assessment will be done before and after the procedure. The
laboratory investigations and the physiological parameters will be recorded before and at the end
of treatment
IX. STATISTICAL ANALYSIS
Clinical symptoms, physiological parameters and laboratory parameters will be analysed
using appropriate statistical methods.
X. CRITERIA FOR ASSESSMENT OF RESULTS
Relief in clinical signs and symptoms will be considered as significant improvement.
XI. TRIAL MONITORING AND DATA ANALYSIS
The progress of the trial will be monitored by Monitoring Unit and staff of CCRAS
Headquarters, New Delhi).
Data analysis will be undertaken at the CCRAS Headquarters, New Delhi.
XII. ETHICAL REVIEW
Each participating center’s Institutional Ethical Committee (IEC) should give clearance
certificate before the project is initiated. Patient’s information sheet and informed consent form
should be submitted alongwith project proposal for approval by IEC. Both should be maintained
in duplicate with one copy given to the patient at the time of entry to the trial.
542
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL TRIAL ON EVALUATION OF EFFECT OF JALAUKAVACHARANA
IN DEEP VEIN THROMBOSIS
CERTIFICATE BY INVESTIGATOR
I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature of the subject: ______________
Name: ____________________________
CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending physician, the purpose of the
clinical trial and the nature of treatment and follow-up, including the laboratory investigations to be
performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so. I, exercising my free power of choice, hereby
give my consent to be included as a subject in the “Clinical trial on evaluation of effect of
Jalaukavacharana in deep vein thrombosis.”
543
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL TRIAL ON EVALUATION OF EFFECT OF JALAUKAVACHARANA
IN DEEP VEIN THROMBOSIS
PATIENT INFORMATION SHEET
544
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL TRIAL ON EVALUATION OF EFFECT OF JALAUKAVACHARANA
IN DEEP VEIN THROMBOSIS
CASE REPORT FORM I – SCREENING
BEFORE TREATMENT
(Enter a in the appropriate box)
1. Centre : ...................................
6. Address : ..............................................................................................................................
1. Both sexes
545
CRITERIA FOR EXCLUSION Yes (1) No (0)
16. Acute MI
546
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL TRIAL ON EVALUATION OF EFFECT OF JALAUKAVACHARANA
IN DEEP VEIN THROMBOSIS
CASE REPORT FORM II – HISTORY
(Enter a in the appropriate box)
1. Centre : ...................................
6. Address : ..............................................................................................................................
7. Educational status:
Laborious 4
Sedentary 5
547
11. Tenderness over swelling
22. Hypertension
23. Diabetes
24. Tuberculosis
25. Malignancy
Personal History
548
31. Constipation No 2 Yes 2
Addiction
Sannipataja 7
Physical Examination
549
Absent (0) Present (1)
44. Anemia
45. Pallor
46. Clubbing
47. Edema
48. Deformities
49. Lymphadenopathy
(Area)__________________________________________________________________
52. CVS
53. CNS
550
56. Digestive system
551
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL TRIAL ON EVALUATION OF EFFECT OF JALAUKAVACHARANA
IN DEEP VEIN THROMBOSIS
FORM III – CLINICAL ASSESSMENT
(0,………………..)
(Enter a in the appropriate box)
1. Centre: ______________________________
4. Address : _______________________________________________________________
7. Date of Assessment :
8. Month of Assessment :
552
17. Overall clinical assessment by the Investigator:
Continuing 1
553
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL TRIAL ON EVALUATION OF EFFECT OF JALAUKAVACHARANA
IN DEEP VEIN THROMBOSIS
FORM IV– LABORATORY INVESTIGATIONS AND PHYSIOLOGICAL
PARAMETERS
(Before and after the treatment)
(Enter a in the appropriate box)
1. Centre: ______________________________
4. Address : _______________________________________________________________
7. Date of Assessment :
8. Month of Assessment :
9. Hb%
10. Urine
10. DLC: P (%) _______ L (%) _______ E (%) _______ M(%) _____ B (%)_______
554
14. PT: ____________
24. LFT : S.Bilirubin, SGOT, SGPT, S.Alkaline phosphatase, S.Albumin, S.Gobulin, A/G ratio
28. S.Sodium,
29. S.Potassium
555
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556
GERIATRIC DISORDERS
SECTION - IX
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558
MULTICENTRIC OPEN CLINICAL TRIAL OF
RASAYANA DRUGS IN HEALTHY ELDERLY PERSONS
559
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560
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
PROTOCOL FOR MULTICENTRIC OPEN CLINICAL TRIAL OF RASAYANA
DRUGS IN HEALTHY ELDERLY PERSONS
I. BACKGROUND
The World Health Organization (WHO) has defined Health as a state of physical, mental
and social wellbeing and not only the absence of disease or infirmity. Over the years, this definition
has changed and now Health is seen as a more holistic state including spiritual component in it.
This present definition of Health by WHO closely resembles the definition laid down in Ayurvedic
texts, more than 3000 years ago. The emphasis on maintaining good health or Swasthya is crucial
to Ayurveda. Ayurveda has presented a total holistic approach for upliftment of body and mind as
well as spirit. Whatever is possible through the control of mind and prana, can be acquired
through Rasayana. Rasayana therapy1 (Rejuvenating group of medicines) aims specially at the
promotion of strength and vitality by replenishing rasa and other Dhatus. The other benefits
secured by Rasayana therapy are promotion of memory and intelligence, immunity against disease
and decay, preservation of youthfulness, lustre, complexion and voice.
Rasayana is of three types according to their effect – 1. Ajasrika (nutritional) 2. Kamya
(desirable) and 3. Naimittika (conditional) and of two types according to the methods of
application - 1. Kutipravesika (confined treatment under specified atmosphere) and 2. Vatatapika
(usual out patient treatment).
There are numerous rasayana drugs among which important ones are Amalaki, Bhallataka,
Nagabala, Pippali, Aswagandha, Shilajit and Svarnabhasma. Brahmi, Shankhapushpi, Guduchi and
Yastimadhu are particularly intellect promoting (Medhya) rasayana drugs though they also promote
physical strength.
A series of clinical and experimental studies have already been conducted to assess the
Rasayana effect of many single and compound preparations. The studies on Chyavanprasa and
Amalaki Rasayana showed significant health promotive effect in elderly volunteers. The Pippali
Ksirapaka provided significant Naimittika rasayana effect in the patients of Tuberculosis, Asthma
and Arthritis reflected through increase in body weight, nitrogen retention, serum protein and
haemoglobin.
References
1. Kasinatha Sastri (1970), Caraka samhita Part-II, First edition, The Chowkhamba Sanskrit Series
Office, Gopal Mandir Lane, P.O. Chowkhamba, Post Box – 8, Varanasi – 1, India.
561
The study on the Medhya Rasayana effect of Shankapushpi, Brahmi and Mandukaparni
showed significant improvement in neurological and psychological parameters. The effect of Brahmi
on acetylcholine, acetylase and cholinesterase has been better than Mandukaparni. Similar studies
were also conducted on Satavari and Vacha with encouraging results.
Aswagandha when administered to 106 apparently normal healthy male volunteers in the
age group of 50-59 years was found to have anti-aging effect. Another study established the
haematinic effect of Aswagandha when administered with milk for 60 days to 60 children. The
effect of another Ayurvedic compound consishting of
Shatavari, Punarnava, Bala, Guduchi, Amalaki and Yasti in 50 apparently healthy male
volunteers in the age group of 45-50 years indicated that the compound has capability of restoring
the age - related functional impairments. A series of clinical studies conducted in different institutes
revealed that Amalaki (Emblica officinalis) as an effective remedy for different gastrointestinal
problems besides its Rasayana effect.
II. OBJECTIVES
• To observe the effects of Rasayana regimen (Triphala churna 5gm OD at night and
Ashwagandha churna 5gm OD at morning daily with water for 4 months) on physical
performance, quality of life and metabolic milieu.
• To observe the clinical safety of Rasayana regimen on clinical & laboratory parameters.
• Effect of Rasayana regimen in apparently healthy elderly on
a. Physical strength
b. Balance
c. Sleep
d. Urge incontinence
e. Constipation
f. Stress level
g. Quality of life
h. Vague ache and pains/ stiffness
i. Appetite
2. Adverse effect of regimen
a. In apparently healthy elderly person with no systemic disease
b. In person with systemic disease like hypertension and drug interactions
562
III. CENTRES
CCRAS identified centers.
IV. SAMPLE SIZE AND METHODS
Sample Size: 50 subjects per center (Total 250 participants)
Drug/Dosage/Duration:
Drug: Triphala churna 5gm OD at night and Ashwagandha churna 5gm OD at morning
daily with water for 4 months.
Design of the study: Multicentric open clinical trial
Duration of the study: 4 months.
V. CRITERIA FOR INCLUSION
1. Age between 50 and 70 years
2. Apparently healthy
3. Co-operative and fully conscious
VI. CRITERIA FOR EXCLUSION
1. Diabetes mellitus
2. Severe bronchial Asthma /COPD
3. Cancer
4. Dementia < 24 score
5. Any symptomatic cardiac disease
6. Chronic debilitating conditions like hepatic/ renal insufficiency (Confirmed through history/
clinical examination)
7. Any acute illness/ serious illness
8. Fever/ delirium
VII. CRITERIA FOR WITHDRAWAL
1. Any serious intercurrent illness
2. Any serious adverse effect or drug interaction
563
VIII. ROUTINE EXAMINATION AND ASSESSMENT
A. The full details of history and physical examination of the patients will be recorded as per
the Case Record Forms (I & II). Clinical assessment including recording of common signs/
symptoms of suspected ADRs will be done before drug administration, at the end of 1st,
2nd, 3rd & 4th month of treatment (Form III). Laboratory investigations will be carried out
before drug administration, at the end of 2nd and 4th month of treatment (Form IV).
IX. FOLLOW - UP
Monthly follow-up will be carried out at the end of each month during the four months
treatment period.
X. STATISTICAL ANALYSIS
Clinical symptoms, physiological parameters and laboratory parameters will be analyzed
using SPSS 15.0 version with appropriate statistical methods.
XI. TRIAL MONITORING AND DATA ANALYSIS
The progress of the trial will be monitored by field visits by Monitoring Unit - CCRAS
HQ, New Delhi. Data analysis will be carried out at the Monitoring Unit.
XII. ETHICAL CLEARANCE
Each participating centre’s Institutional Ethics Committee (IEC) should give clearance
certificate before the project is initiated.
a. List of Clinical Symptoms to be taken into account for assessment using VAS (Visual
Analogue Scale):-
1. Dizziness
2. Constipation
3. Urge incontinence
4. Aching muscles
5. Joint pain
6. Joint stiffness
7. Sleep abnormality
8. Loss of appetite
9. Vague pain
10. Fatigue
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11. Generalized weakness
b. Clinical parameters to record
1. Height
2. Weight
3. Pulse rate
4. Blood pressure
Supine (diastolic/systolic__________)
Standing (diastolic/systolic__________)
Orthostatic hypotension – Yes/ No
5. Upper mid arm circumference
6. Skin fold thickness
7. BMI (body weight in Kgs./Height in meters2)
8. Waist circumference
9. Waist: hip ratio
10. Grip strength both hands
11. Get up and go test
12. Walking distance in 1 min.
13. General physical examination
c. Scores
1. Geriatric depression score
2. WHO-QOL score/ CDC score for health quality
3. HMSE (Hindi version of mental system evaluation)
4. Hamilton anxiety scale
d. Laboratory investigations
1. Complete haemogram (Complete blood picture)
2. GBP for anemia
3. Complete urine examination
565
4. Serum Iron
5. TIBC
6. Plasma glucose
a. Fasting
b. Post prandial
7. Lipid profile
a. HDL
b. LDL
8. Liver function tests
a. Serum proteins
i. Albumin
ii. Globulin
b. Serum bilirubin
i. Total
ii. Direct
c. SGPT
d. SGOT
e. Serum Alkaline Phosphatase
9. Serum triglycerides
10. Serum Cholesterol
11. Serum electrolytes
12. Renal function tests
a. Blood urea
b. Serum creatinine
13. Serum uric acid
14. Serum Thyroid Stimulating Hormone (TSH)
15. Serum calcium
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16. Serum phosphates
e. Special tests
1. ECG
2. Pulmonary Function Test (PFT)
f. Marker of inflammation
1. C Reactive Proteins (CRP)
2. TNF ?
3. IL-6
g. Serum melatonin
h. Free radical system
a. Malonyl aldehyde
b. Catalase
c. Super oxide dismutase
d. Glutathione
e. Peroxidase
i. Prostate specific antigen
j. Test for insulin resistance
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
PROTOCOL FOR MULTICENTRIC OPEN CLINICAL TRIAL OF RASAYANA
DRUGS IN HEALTHY ELDERLY PERSONS
WRITTEN INFORMED CONSENT FORM
CERTIFICATE BY INVESTIGATOR
I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature of the subject: ______________
Name: ____________________________
CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending physician, the purpose of the
clinical trial and the nature of drug treatment and follow-up, including the laboratory investigations
to be performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so.
I, exercising my free power of choice, hereby give my consent to be included as a
participant in the clinical trial of Triphala churna 5gm OD at night and Ashwagandha churna 5gm
OD at morning daily with water for 4 months on the general health of the aged persons.
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC OPEN CLINICAL TRIAL OF RASAYANA DRUGS IN
HEALTHY ELDERLY PERSONS
PATIENT INFORMATION SHEET
Ayurveda has laid emphasis on maintenance of positive health and prevention of diseases,
besides management/ treatment of diseases. Rasayana Therapy of Ayurveda promotes health of
individuals especially elderly persons. The present study is aimed to evaluate selected Ayurvedic
Rasayana drugs for their efficacy in the promotion of health of elderly people.
You are invited to participate in this study where you will be provided with the trail drugs
and require to take Triphala churna 5gm OD at night and Ashwagandha churna 5gm OD at
morning daily with water for 4 months. Previous observations in clinical and experimental studies
have shown promising effect of these drugs in the promotion of health. About 250 healthy elderly
persons from this and other hospitals around the country will be taking part in this study.
Your doctor will explain clearly what you have to do. It is important that you follow the
instructions scrupulously. The study will take approximately 16 weeks to complete. During this
period, you are expected to visit the hospital five times. The interval between the first, second,
third, fourth and fifth visits will be four weeks (one month).
Before you start treatment, during the first visit to the clinic, you will undergo a complete
physical examination, ECG and an X-ray, Blood and urine samples, etc. will also be taken. This
is to make sure that you are eligible for the study.
If you are found eligible, you would be put on trial treatment for 16 weeks. At each visit,
you will be supplied with sufficient quantities of drugs to last until your next visit.
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC OPEN CLINICAL TRIAL OF RASAYANA DRUGS IN
HEALTHY ELDERLY PERSONS
CASE REPORT FORM I - SCREENING
1. Centre : ...................................
6. Address : ..............................................................................................................................
2. Apparently healthy
4. Diabetes mellitus
6. Cancer
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11. Fever/ delirium
1. S. Bilirubin
2. SGPT: 0 – 35 IU/L
3. SGOT: 0 – 35 IU/L
• Albumin: 15 - 40 g/dl
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC OPEN CLINICAL TRIAL OF RASAYANA DRUGS IN
HEALTHY ELDERLY PERSONS
CASE REPORT FORM II – HISTORY
2. Centre :__________________
D D M M Y Y
7. Address : ..............................................................................................................................
8. Educational status:
Living alone 1
572
Living with his/her family 3
Others (specify) 5
11. Income (per capita per month) of the participant and Head of the family
in Rs __________________________________________________________________
12. Dizziness
13. Constipation
17. Stiffness
21. Fatigue
23. Fever
573
If yes, indicate frequency of attacks in last six months: ____________________________
27. Tuberculosis
D. Personal History
30. Alcohol
32. Tobacco
Sannipataj
Area __________________________________________________________________
574
E. General systemic examination Normal (0) Abnormal (1)
39. Vision
40. Hearing
45. Nausea
46. Diarrhoea
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC OPEN CLINICAL TRIAL OF RASAYANA DRUGS IN
HEALTHY ELDERLY PERSONS
CASE REPORT FORM III A – CLINICAL ASSESSMENT
(ON 0 DAY)
1. Centre: ______________________________
5. Date of Assessment :
6. Dizziness
7. Constipation
8. Urge incontinence
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Normal (0) Impaired (1)
17. Vision
18. Hearing
If present, specify_________________________
B. Physical Examination
577
37. Get up and go test _____________
C. Score system
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC OPEN CLINICAL TRIAL OF RASAYANA DRUGS IN
HEALTHY ELDERLY PERSONS
CASE REPORT FORM III B – CLINICAL ASSESSMENT
(ON 30TH DAY, 60th DAY, 90th DAY & 120th DAY)
(USE SEPARATE FORM ON EACH VISIT)
1. Centre: ______________________________
5. Date of Assessment :
6. Dizziness
7. Constipation
8. Urge incontinence
579
Normal (0) Impaired (1)
17. Vision
18. Hearing
If present, specify_________________________
B. Physical Examination
580
37. Get up and go test _____________
C. Score system
45. Nausea
47. Diarrhoea
Continuing 1
Completed 2
581
D. No. of sachets issued (if continuing):
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC OPEN CLINICAL TRIAL OF RASAYANA DRUGS IN
HEALTHY ELDERLY PERSONS
CASE REPORT FORM IV – LABORATORY INVESTIGATIONS
(ON 0 DAY, 60th DAY & 120th DAY)
(USE SEPARATE FORM ON EACH VISIT)
1. Centre: ______________________________
5. Date of Assessment :
6. Routine _______________________________
7. Microscopic ___________________________
9. Differential count: P ____ (%) L ____ (%) E ____ (%) M ____ (%) B ____ (%)
583
C. Plasma glucose (mg/dl)
27. Sodium____________
584
34. Serum calcium (mg/dl) ____________________
H. Special tests
I. Marker of inflammation
43. Catalase
45. Glutathione
46. Peroxidase
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC OPEN CLINICAL TRIAL OF RASAYANA DRUGS IN
HEALTHY ELDERLY PERSONS
DRUG COMPLIANCE REPORT FORM – I
(To be translated in to local language)
(To be issued on 1st visit (0 day), 2nd visit (30th day), 3rd visit (60th day) and 4th visit (90th
day) and taken back on 2nd visit (30th day), 3rd visit (60th day), 4th visit (90th day) and 5th visit
(120th day))
Please come for next visit on ______________________________ (Date and time is to be
filled by the Investigator)
Instructions to trial participant
• Please take 5 gm of Ashwagandha churna (1 sachet) daily at 9 AM with water (approx.
150 ml.).
• Please take 5 gm of Triphala churna (1 sachet) daily at 9 PM with water (approx. 150
ml.).
• Please return the empty sachets after taking medicine along with the compliance report
form duly filled.
• Please come with empty stomach and bring breakfast along with you during next visit.
Day Date Morning dose (around 9 AM) Evening dose (around 9 PM)
(5 gm of Ashwagandha churna) (5 gm of Triphala churna)
Please put Please enter Please put Please enter
mark after the time mark after the time
taking the taking the
medicine medicine
1.
586
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
23.
24.
25.
26.
27.
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28.
29.
30.
Date: _______________________________________________________________________
588
RECEIPT
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC OPEN CLINICAL TRIAL OF RASAYANA DRUGS IN
HEALTHY ELDERLY PERSONS
Date: _______________
589
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590
DOUBLE BLIND CLINICAL TRIAL OF SIDDHA KAYA
KALPA DRUGS IN HEALTHY ELDERLY PERSONS
591
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592
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
DOUBLE BLIND CLINICAL TRIAL OF SIDDHA KAYA KALPA DRUGS IN
HEALTHY ELDERLY PERSONS
I. BACKGROUND
In Siddha system health is defined as a state of physical, mental, social and spiritual well
being, devoid of any degenerative disorders. Kayakalpa drugs ensure preventive aspects and also
the longevity. In Siddha system, elevation of man to attain the highest eternal bliss forever is
regarded as the highest form. Siddha’s Kaya Kalpa paved way for such highest form.
Kaya kalpa is divided into two main categories. One is Kalpa yogam and other is Kalpa
avizhtham. Eight types of yogic stages are described which helps in the elevation of man to a
supernatural being under kalpa yogam1.
Drugs which are capable of preventing as well as curing chronic and degenerative diseases,
and also used as rejuvenators in prolongation of life are called Kalpa avizhtham. Siddha system has
a unique way in the preparation of Kalpa drugs with particular specified herbs, minerals and
metals. It is divided into two categories. One is general and the other is special. The general kalpa
drugs are used in normal individuals aiming at promotion of strength, vitality and vigor, improving
memory and intelligence, immunity against disease and decay, preservation of youthfulness, lusture,
complexion and voice. The special kalpa drugs, which are used against chronic and degenerative
disorders specifically to eradicate various disease conditions and bring back the vigor and vitality
in the individuals.
II. OBJECTIVE
To evaluate the efficacy of herbomineral kayakalpa drugs in the promotion of positive
health in healthy volunteers.
III. CENTRES
CCRAS identified centers.
References
1.
593
IV. SAMPLE SIZE AND METHODS
Sample Size : 120 (60 patients in each group)
Drug/Dosage/Duration
Drug : Nelli karpam (Nelli vattral powder + abiraga chendooram.
Dosage : Nelli vattral Powder 1 gm. Abiraga Chendooram 200 mg.with
honey twice a day.
Duration : 40 days.
Design of : Randomized double blind Placebo controlled study.
the study
Duration of : 40 days drug therapy with a follow up for 6 months without drug
the study
Period of : 220 days for each case. Total duration will be three years to
Study complete the trial at each Centre
Follow – Up : Two follow-up will be carried out after three months and after six
months of the completion of treatment
V. CRITERIA FOR INCLUSION
1. Age between 60 and 69 years.
2. Apparently healthy
3. Ambulatory and Co-operative.
VI. CRITERIA FOR EXCLUSION
1. Diabetes
2. Hypertension
3. Bronchial Asthma
4. Cancer
5. Manifest Cardiac ailment
6. AIDS
7. Jaundice
8. Kidney related diseases
9. Dementia Grade II & above
594
10. Person undergoing treatment for any other serious illness
VII. CRITERIA FOR WITHDRAWAL:
During the course of the trial treatment, if any serious condition develops which requires
urgent treatment such subjects may be withdrawn from the trial and managed by the Principal
Investigator accordingly.
VIII. ROUTINE EXAMINATION AND ASSESSMENT
The full details of history and physical examination of the patients will be recorded as per
the proforma (Forms I & IA). Clinical assessment will be done before preparatory regimen, at the
end of five weeks, 3rd month and 6th month during treatment and at the end of 3rd and 6th
month follow up (Form II). The laboratory investigations and the physiological parameters will be
recorded before drug administration, at the end of one month, at the end of treatment and at the
end of follow-up. [Form III]
IX. STATISTICAL ANALYSIS
Clinical symptoms, physiological parameters and laboratory parameters will be analyzed
using appropriate statistical methods.
X. CLINICAL ASSESSMENT
List of Clinical Symptoms to be taken into account for assessment using VAS (Visual
Analogue Scale): -
1. Dizzy spells/Giddiness
2. Breathlessness on exertion
3. Tremors
4. Constipation
5. Urgency to micturate
6. Aching muscles or joints
7. Pain/Stiffness in joints
8. Numbness
9. Abnormality in sleep
10. Loss of appetite
595
XI. TRIAL MONITORING AND DATA ANALYSIS
The progress of the trial will be monitored by CCRAS Headquarters, New Delhi. Data
analysis will be undertaken at Central Research Institute for Siddha, Chennai.
XII. ETHICAL REVIEW
Institutional Ethical Committee (IEC) should give clearance certificate before the project is
initiated. Patient’s information sheet and informed consent form should be submitted alongwith
project proposal for approval by IEC. Both should be maintained in duplicate with one copy
given to the patient at the time of entry to the trial
XIII. TRAVEL LING EXPENSES FOR RESEARCH SUBJECTS
A consolidated amount of Rs…../- per visit will be paid to subject.
XIV. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
Short-term two-day training will be provided to the Investigators and Laboratory
personnel involved in the multi-centric trial at CCRAS Hqrs. and Central Research Institute (Ay.),
New Delhi. The investigators and technicians will be detailed about the clinical trial conduct and
laboratory procedures in order to maintain the uniformity.
XV. LABORATORY INVESTIGATIONS
The Laboratory Investigations (Pathological/Biochemical, etc.), which are not available at
research Institutes should be conducted at identified reputed labs /Government Institutes under
intimation to this Council following codal formalities.
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
DOUBLE BLIND CLINICAL TRIALOF SIDDHA KAYA KALPA DRUGS IN
HEALTHY ELDERLY PERSONS
WRITTEN INFORMED CONSENT FORM
CERTIFICATE BY INVESTIGATOR
I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature of the subject: ______________
Name: ____________________________
CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending physician, the purpose of the
clinical trial and the nature of drug treatment and follow-up, including the laboratory investigations
to be performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so.
I, exercising my free power of choice, hereby give my consent to be included as a subject
in the clinical trial of Nellikarpam – Nelli vattral powder 1 gm and Abbirga chendooram 200 mg.
twice a day with honey for 40 days on the general health of the Aged persons.
597
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
DOUBLE BLIND CLINICAL TRIALOF SIDDHA KAYA KALPA DRUGS IN
HEALTHY ELDERLY PERSONS
PATIENT INFORMATION SHEET
598
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
DOUBLE BLIND CLINICAL TRIALOF SIDDHA KAYA KALPA DRUGS IN
HEALTHY ELDERLY PERSONS
CASE REPORT FORM I - SCREENING
BEFORE TREATMENT
(Enter a in the appropriate box)
1. Centre : ...................................
6. Address : ..............................................................................................................................
8. Apparently healthy
10. Diabetes
11. Hypertension
13. Cancer
15. AIDS
599
16. Jaundice
600
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
DOUBLE BLIND CLINICAL TRIAL OF SIDDHA KAYA KALPA DRUGS
INHEALTHY ELDERLY PERSONS
CASE REPORT FORM II – HISTORY
(Enter a in the appropriate box)
1. Centre : ...................................
7. Address : ..............................................................................................................................
8. Educational status:
Living alone 1
601
Living with his/her spouse 2
Others (specify) 5
12. Income (per capita per month) of the participant and Head of the family
in Rs __________________________________________________________________
Chief complaint with duration (if any) Absent (0) Present (1) Duration
13. Constipation
15. Fatigue
16. Dizziness
17. Weakness
18. Forgetfulness
19. Fever
602
History of Past illness No (0) Yes (1)
23. Tuberculosis
Personal History
(a) Initiation:
(b) Maintenance:
29. Constipation
30. Smoking
31. Tobacco
603
32. Alcohol
Sannipataj
Physical Examination
42. Anemia
43. Deformities
44. Lymphadenopathy
Area: __________________________________________________________________
604
Systemic examination Normal (0) Abnormal (1)
48. Vision
49. Hearing
605
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
DOUBLE BLIND CLINICAL TRIALOF SIDDHA KAYA KALPA DRUGS IN
HEALTHY ELDERLY PERSONS
CASE REPORT FORM III – CLINICAL ASSESSMENT AND PHYSIOLOGICAL
PARAMETERS
(0, 5 weeks, 3, 6, 9,12th months)
1. Centre : ...................................
7. Date of Assessment :
8. Month of Assessment :
15. All the symptoms for the clinical assessment are non-specific without any clinical illness to
account for.
606
17. Tremors 0____________________________________10
Continuing 1
PHYSIOLOGICAL PARAMETERS
Hand Grip
607
31. Seated Stature (cm) __________________
FEV (L)_______ PEFR (L) ______ RV (L) ______ FVC (L) ______
608
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
DOUBLE BLIND CLINICAL TRIALOF SIDDHA KAYA KALPA DRUGS IN
HEALTHY ELDERLY PERSONS
CASE REPORT FORM III A - ADVERSE EVENTS RECORD
(0, 15, 30, 45, 60, 75, 90 days)
1. Centre : ...................................
7. Address : Permanent postal Address with phone number and email if any.
..............................................................................................................................................
..............................................................................................................................................
ADVERSE EVENTS
1. Does the patient have any symptoms with medication in trial group ? Yes No.
Please complete all sections & enter l approximate information in numbers in open boxes
1 2 3 4
Adverse
Experience
Date started
609
Date
Time
Date stopped
Pattern
Isolated-1
Intermittent-2
Continuous-3
Severity
Mild-1
Moderate-2
Severe-3
*Mild-No interference with usual activity. *Moderate-Significant interference with usual
activities. *Severe-Prevents usual activities.
Serious*
Yes-1
No-2
Serious ADE is defined as fatal, life-threatening, permanently, disabling requires inpatient
hospitalization or as a congenital anomaly, cancer or overdose. If yes, please till serious
Adverse experiences report form provided. In case of Serious adverse event sponsor should
be informed immediately telephonically.
Relationship to study
medication
Unrelated-1
Possible-2
Probable-3
610
Unrelated: A reaction that does not follow a reasonable temporal sequence from the
administration of the drug; or a known adverse reaction pattern of the suspected drugs
could have been produced by the patients clinical stage, intermittent illness, trauma, accidents
etc:
Possible: follows a reasonable temporal sequence from administration of the drug; follows a
known response pattern to the suspected drug but could have been produced by the patients
clinical stage or other modes of therapy administered to the patients;
Probable: follows a reasonable temporal sequence from administration of the drug; follows a
known response pattern to the suspected drug; that could not be reasonably explained by the
known characteristics of the patients clinical state.
611
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
DOUBLE BLIND CLINICAL TRIALOF SIDDHA KAYA KALPA DRUGS IN
HEALTHY ELDERLY PERSONS
(0, 5 week, 6th and 12th month)
CASE REPORT FORM IV – LABORATORY INVESTIGATIONS
1. Centre : ...................................
7. Date of Assessment :
9. Urine Examination
Routine____________ Microscopic___________
11. TC (Cells/Cmm.)_____________________
612
16. Blood Sugar – PP(mg./dl) _______________
35. X-ray one knee joint [ 0 & 12th Month only ] ________________________________
613
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614
REPRODUCTIVE SYSTEM
SECTION - X
Blank
616
MULTICENTRIC DOUBLE BLIND CLINICAL TRIAL
OF AYURVEDIC HERBAL FORMULATION IN THE
TREATMENT OF MENOPAUSAL SYNDROME
617
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618
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC DOUBLE BLIND CLINICAL TRIAL OF AYURVEDIC
HERBAL FORMULATION IN THE TREATMENT OF MENOPAUSAL
SYNDROME
I. BACKGROUND
At Menopause, ovarian estrogen and progestogen production fall to low levels, which in
some women are associated with a series of signs and symptoms and physiological consequences
of sex steroid deficiency. Deficiency of estrogens may result in vasomotor manifestations such as
hot flushes, perspiration, palpitation and headache. The women may also suffer from urogenital
symptoms such as vaginal itching, vaginal dryness and psychological symptoms such as irritability
depression and insomnia. The symptoms described above are known as Menopausal Syndrome.
Available treatment modalities in Western System of Medicine have some limitations in offering a
comprehensive satisfactory solution to the problem. Hence there is always search for safe and
effective treatment modality which does not require expensive monitoring system besides better
compliance to the subjects1.
II. OBJECTIVE
To assess the efficacy of an Ayurvedic formulation in the management of Menopausal
Syndrome.
III. CENTRES
CCRAS identified centers.
IV. SAMPLE SIZE AND METHODS
Sample Size: 100 patients at each Centre, 50 control and 50 trial cases
Drug/Dosage/Duration:
References
1. Dr. Nirmala Joshi (1999) Ayurvedic concept in Gynaecology,) 2nd Edition (1999), Published by
Chaukabha Sanskrita Pratisthana, Delhi, India.
2. Dr. P.V. Tiwari (1990) Stri Roga Part II 1st Edition Chaukhamba Orientalia, Delhi.
3. Dr. D.C. Dutta, Text book of Gynaecology, 5th Edition2009, Published by New central book
agency, Delhi
619
Drug – Aswagandha, Madhuyasti, Balamula, Saunf,Tila-50mg each and Jayanati beeja-
100mg
Dosage – 700mg –twice a day
Duration – 6 months
Design of the study – Randomized Double – blind Placebo controlled study
Duration of the study- 6 months drug therapy with a follow up for 3 months without
drug
Total period of study - 9 months. Total duration will be three years to complete the trial
at each Centre.
Follow – Up: One follow-up will be carried out after three months of the completion of
treatment
V. CRITERIA FOR INCLUSION
1. Age: More than 40 years and less than 55 years
2. History of amenorrhoea for not less than 6 months
3. Score of 10 or more as per the CCRAS scoring of Menopasual Syndrome.
VI. CRITERIA FOR EXCLUSION
1. Age: Less than 40 years and more than 55 years
2. CCRAS Menopausal score less than 10
3. Organic lesions like tuberculosis, STD, Cancer, Liver and Kidney diseases
4. Surgical menopause
5. Established cases of any mental illness
6. Diabetes mellitus
7. Unexplained uterine bleeding
8. Cases undergoing treatment for any other serious illness
VII. CRITERIA FOR WITHDRAWAL
A patient may be withdrawn from the trial on account of the following
1. Development of any major ailment, side effects necessitating institution of new modalities of
treatment.
2. Worsening of symptoms.
620
3. Patient’s failure to report for follow-up or irregular medication [Missing 10 or More
doses]
VIII. ROUTINE EXAMINATION AND ASSESSMENT
The full details of history and physical examination of the patients will be recorded as per
the proforma (Forms I & IA). Clinical assessment will be done before drug administration, at the
end of 1st month, 2nd, 3rd, 4th, 5th and 6th month during treatment and at the end of 3rd
month follow up (Form II). The laboratory investigations i.e. Urine Examination, Stool
examination, TC, DC (P, L, E, M, B), Hb%, ESR (1st hour), PCV, Blood Sugar (PP), Lipid
Profile, B. Urea, S. Creatinine, Uric acid, Total proteins, S. Albumin, S. Globulin, A/G Ratio,
SGOT, SGPT, Pap Smear, Thyroid function tests (T3,T4,TSH) LH, FSH Prolactin, X-Ray Chest,
Transe Vaginal Sonography will be recorded before drug administration, at the end of treatment
and at the end of follow-up. [Form-III]
IX. STATISTICAL ANALYSIS
Clinical symptoms and laboratory parameters will be analyzed using appropriate statistical
methods.
X. CLINICAL ASSESSMENT
List of Clinical Symptoms to be taken into account for assessment of the effect of the
treatment of Menopausal Syndrome.
SYMPTOMS SCORE
1. Hot flushes 5
2. Night Sweating 5
3. Insomnia 3
4. Muscle/Joint pain 3
5. Anxiety 2
6. Mood fluctuation 2
7. Irritability 2
8. Dryness/itching in Vagina 3
9. Altered sexual desire 1
10. Fatigue 2
11. Stress incontinence 2
Total 29
621
XI. TRIAL MONITORING AND DATA ANALYSIS
The progress of the trial will be monitored by field visits by Monitoring Unit of CCRAS.
And under Guidance of the Clinical Trial Monitor. Data analysis will be undertaken at the
Monitoring Unit of CCRAS.
XII. ETHICAL REVIEW
Each participating centre’s Institutional Ethical Committee (IEC) or Head of the Institution
should give clearance certificate before the project is initiated. Patient’s information sheet and
informed consent form should be submitted alongwith project proposal for approval by IEC/ Head
of the Institution. Both should be maintained in duplicate with one copy given to the patient at the
time of entry to the trial.
XIII. TRAVELLING EXPENSES FOR RESEARCH SUBJECTS
A consolidated amount of Rs…….../- per visit will be paid to subject.
XIV. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
Short-term two-day training will be provided to the Investigators and Laboratory
personnel involved in the multi-centric trial at CCRAS Hqrs. and Central Research Institute (Ay.),
New Delhi. The investigators and technicians will be detailed about the clinical trial conduct and
laboratory procedures in order to maintain the uniformity.
XV. LABORATORY INVESTIGATIONS
The Laboratory Investigations (Pathological/Biochemical, etc.), which are not available at
research Institutes should be conducted at identified reputed labs /Government Institutes under
intimation to this Council following codal formalities.
622
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC DOUBLE BLIND CLINICAL TRIAL OF AYURVEDIC
HERBAL FORMULATION IN THE TREATMENT OF MENOPAUSAL
SYNDROME
WRITTEN INFORMED CONSENT FORM
CERTIFICATE BY INVESTIGATOR
I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature Investigator ______________
Name: ____________________________
CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending physician, the purpose of the
clinical trial and the nature of drug treatment and follow-up, including the laboratory investigations
to be performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so.
I, exercising my free power of choice, hereby give my consent to be included as a subject
in the clinical trial of _______________________ on the Menopausal Syndrome.
623
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC DOUBLE BLIND CLINICAL TRIAL OF AYURVEDIC
HERBAL FORMULATION IN THE TREATMENT OF MENOPAUSAL
SYNDROME
PATIENT INFORMATION SHEET
624
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC DOUBLE BLIND CLINICAL TRIAL OF AYURVEDIC
HERBAL FORMULATION IN THE TREATMENT OF MENOPAUSAL
SYNDROME
CASE REPORT FORM I - SCREENING
BEFORE TREATMENT
(Enter a in the appropriate box)
1. Centre : ...................................
6. Address : ..............................................................................................................................
9. Surgical menopause
625
10. Established cases of mental disorder
626
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC DOUBLE BLIND CLINICAL TRIAL OF AYURVEDIC
HERBAL FORMULATION IN THE TREATMENT OF MENOPAUSAL
SYNDROME
CASE REPORT FORM II – HISTORY
(Enter a in the appropriate box)
1. Centre : ...................................
7. Address : ..............................................................................................................................
8. Educational status:
627
12. Marital status: Single Married Separated
Window Widower
Living alone
Others (specify)
Chief complaint with duration in weeks (If any) Absent (0) Present (1) Duration
16. Insomnia
18. Anxiety
20. Irritability
23. Fatigue
628
Personal History
Loose Stool 4
Addiction
Menstrual History:
629
Obstetrics History:
Sannipataj
Physical Examination
49. Pallor
50. Hirsutism
51. Lymphadenopathy
If present, specify
52. CVS
If abnormal details________________________________________________________
630
53. Respiratory system
54. CNS
If abnormal, details________________________________________________________
If abnormal, details________________________________________________________
631
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC DOUBLE BLIND CLINICAL TRIAL OF AYURVEDIC
HERBAL FORMULATION IN THE TREATMENT OF MENOPAUSAL
SYNDROME
FORM III – CLINICAL ASSESSMENT
(0, 1, 2, 3, 4, 5, 6 & 9th Month)
1. Centre : ...................................
7. Date of Assessment :
8. Month of Assessment :
9. Address : ..............................................................................................................................
12. Insomnia
14. Anxiety
16. Irritability
632
18. Altered sexual desire
19. Fatigue
If yes, details:____________________________________________________________
Deteriorated
Continuing
Died 3 Cause:_______________________________
633
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC DOUBLE BLIND CLINICAL TRIAL OF AYURVEDIC
HERBAL FORMULATION IN THE TREATMENT OF MENOPAUSAL
SYNDROME
CASE REPORT FORM III A - ADVERSE EVENTS RECORD
(0, 1, 2, 3, 4, 5, 6 & 9th Month)
4. Centre…………………………
9. Address : ................................................................................................................................
ADVERSE EVENTS
1. Does the patient have any symptoms with medication in trial group? Yes No
Please complete all sections & enter l approximate information in numbers in open boxes
1 2 3 4
Adverse
Experience
634
Date started
Date
Time
Date stopped
Pattern
Isolated-1
Intermittent-2
Continuous-3
Severity
Mild-1
Moderate-2
Severe-3
Serious*
Yes-1
No-2
635
Relationship
to study
medication
Unrelated-1
Possible-2
Probable-3
Unrelated: A reaction that does not follow a reasonable temporal sequence from the
administration of the drug; or a known adverse reaction pattern of the suspected drugs could
have been produced by the patients clinical stage, intermittent illness, trauma, accidents etc:
Possible: follows a reasonable temporal sequence from administration of the drug; follows a
known response pattern to the suspected drug but could have been produced by the patients
clinical stage or other modes of therapy administered to the patients;
Probable: follows a reasonable temporal sequence from administration of the drug; follows a
known response pattern to the suspected drug; that could not be reasonably explained by the
known characteristics of the patient's clinical state.
636
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC DOUBLE BLIND CLINICAL TRIAL OF AYURVEDIC
HERBAL FORMULATION IN THE TREATMENT OF MENOPAUSAL
SYNDROME
CASE REPORT FORM IV – LABORATORY INVESTIGATIONS
( 0, 6th AND 9th MONTH)
1. Centre : ...................................
7. Date of Assessment :
8. Address : ..............................................................................................................................
9th month 2
Routine____________ Microscopic___________
12. TC (Cells/Cmm.)_____________________
13. DC: P (%) ______ L (%) ______ E (%) ______ M (%) _______ B (%) _______
637
15. ESR (1st hour.) (mm) _________________
The tests from S. No. 31 to 36 will be carried out only once at 0 month.
638
36. Prolactin (ug/L) __________________________________
PHYSIOLOGICAL PARAMETERS
639
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC DOUBLE BLIND CLINICAL TRIAL OF AYURVEDIC
HERBAL FORMULATION IN THE TREATMENT OF MENOPAUSAL
SYNDROME
CASE RECORD FORM – V RECORD OF UNSCHEDULED VISITS OF THE
PATIENT
1. Centre : ...................................
8. Address : ..............................................................................................................................
640
TO STUDY THE EFFICACY OF AYURVEDIC
FORMULATION IN THE TREATMENT OF
DYSFUNCTIONAL UTERINE BLEEDING
641
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642
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
PROTOCOL TO STUDY THE EFFICACY OF AYURVEDIC FORMULATION IN
THE TREATMENT OF DYSFUNCTIONAL UTERINE BLEEDING
I. BACKGROUND
Dysfunctional Uterine Bleeding (DUB) is excessive or prolonged bleeding during menstrual
period. In addition, it also includes the menstruation with short inter menstrual period, for which no
demonstrable cause is found. Though no active reproductive age is exempt, the disease is mostly
found in early puberty and or late reproductive life (peri-menopausal period). Modern Medicine
does not have a permanent cure and most of the time patients have to opt for hysterectomy.
Rakta Pradara or Asragdhara mentioned in Ayurved is a broad term which covers all sorts of
excessive uterine bleeding. For the present study, exclusively dysfunctional uterine bleeding has
been taken up. Ayurvedic system is having many effective remedies for this problem. Among them
the combination of Ashoka- 100mg., Lodhra –50mg., Nagakeshara-50mg.,Doorva-100mg are
selected for the present study. The previous observations in clinical and experimental studies have
shown promising effect of these drugs in the management of DUB.
II. OBJECTIVE
To assess the efficacy of an Ayurvedic formulation in the management of Dysfunctional
Uterine Bleeding (DUB).
III. CENTRES
CCRAS identified Centres.
IV. SAMPLE SIZE AND METHODS
Sample Size : 50 cases
Treatment : Two capsule of 300mg each containing Ashoka and
Doorva (two parts each), Lodhra and Nagakeshara (one
part each) twice a day, for three months.
Duration : 3 months.
Design of the study : Open trial
Duration of the study : Three months drug therapy with follow up for six months.
Total period of study will be nine months for each case.
Period of Study : 9 months for each case. Total duration will be three years
to complete the trial at each Centre.
643
Follow – Up : Two follow-ups will be carried out after three and six
month of the completion of treatment.
V. CRITERIA FOR INCLUSION
1. Age: between menarche and menopause
2. Excessive bleeding during menstruation (change of more than 5 soiled pads in a day)
3. Passing of large clots
4. Prolonged menstrual bleeding (more than 7 days)
5. Excessive bleeding for more than 2 consecutive cycles
VI. CRITERIA FOR EXCLUSION
1. Blood dyscrasias
2. Intrauterine growth such as myoma, endometrial polyp etc.
3. Cancer of cervix and or uterus
4. Hb% less than 7 gm.
5. Endocrinal disorders
6. Any other systemic disorders likely to influence menstrual cycle
7. Case undergoing treatment for any other serious illness.
VII. CRITERIA FOR WITHDRAWAL
The patients will be withdrawn from the study
1. If the condition worsens
2. Development of any other serious disease
3. Patient’s failure to report for follow-up or irregular medication [Missing 10 or More Doses]
The cases withdrawn from the study will be managed by the Investigator
VIII. ROUTINE EXAMINATION AND ASSESSMENT
The full details of history and physical examination of the patients will be recorded as per
the proforma (Forms I & IA). Clinical assessment will be done before drug administration, at the
end of 1st, 2nd and 3rd month, during treatment and at the end of 6th and 9th month during follow
up (Form II). Required laboratory investigations will be carried out to exclude cases as specified
in the criteria for exclusion (Form-III).
644
IX. CRITERIA FOR ASSESSMENT OF RESULTS
Reduction in menstrual flow (i.e. decrease in use of soiled pads (three or less) in a day),
total stoppage of passing of large clots and reduction in menstrual bleeding period to 7 days or
less will be considered as significant improvement.
X. STATISTICAL ANALYSIS:
Data on number of pads used, duration of flow of menstrual period and Disappearance of
large clots will be tabulated and analyzed using appropriate statistical methods.
XI. TRIAL MONITORING AND DATA ANALYSIS
The progress of the trial will be monitored by field visits by Monitoring Unit of CCRAS.
Data analysis will be undertaken at the Monitoring Unit of CCRAS.
XII. ETHICAL REVIEW
A. Ethical Committee (IEC): The proposal will be placed before Ethical Committee (IEC)
of trial center for getting clearance certificate before the project is initiated. Patient’s
information sheet and informed consent form will be submitted along with project proposal
for approval by EC. Both will be maintained in duplicate with one copy given to the
patient at the time of entry to the trial.
B. Data and Safety Monitoring Board: A Data and safety monitoring board (DSMB) at
Hqrs will carefully monitor the data and side effects during the period of study and put in
a place where by prompt reporting of adverse events occur. The data will be reviewed as
every 20 participants entered the study and administered the trial drugs. The research team
will report immediately to the PI and Data Monitoring Board for any life threatening
conditions whether they are perceived to be study related or not. The Board decides
whether the adverse effects warrant discontinuation of the study protocol. Protocols will be
written and approved for the treatment of study related adverse events
XIII. TRAVELLING EXPENSES FOR RESEARCH SUBJECTS
A consolidated amount of Rs. ______ per visit will be paid to subject put on treatment.
XIV. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
Short-term two-day training will be provided to the Investigators and Laboratory
personnel involved in the trial at CCRAS Hqrs. The investigators and technicians will be detailed
about the clinical trial conduct and laboratory procedures in order to maintain the uniformity.
XV. LABORATORY INVESTIGATIONS
The Laboratory Investigations (Pathological/Biochemical, etc.), which are not available at
research Institutes should be conducted at identified reputed labs /Government Institutes under
intimation to this Council following codal formalities.
645
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL STUDY TO STUDY THE EFFICACY OF AYURVEDIC
FORMULATION IN THE TREATMENT OF DYSFUNCTIONAL UTERINE
BLEEDING
WRITTEN INFORMED CONSENT FORM
CERTIFICATE BY INVESTIGATOR
I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature of the subject: ______________
Name: ____________________________
CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending physician, the purpose of the
clinical trial and the nature of drug treatment and follow-up, including the laboratory investigations
to be performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so.
I, exercising my free power of choice, hereby give my consent to be included as a subject
in the clinical trial assessment of the effect of Ayurvedic formulation in the treatment of
dysfunctional uterine bleeding.
646
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL STUDY TO STUDY THE EFFICACY OF AYURVEDIC
FORMULATION IN THE TREATMENT OF DYSFUNCTIONAL UTERINE
BLEEDING
PATIENT INFORMATION SHEET
647
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL STUDY TO STUDY THE EFFICACY OF AYURVEDIC
FORMULATION IN THE TREATMENT OF DYSFUNCTIONAL UTERINE
BLEEDING
CASE REPORT FORM I - SCREENING
1. Centre : ...................................
6. Address : ..............................................................................................................................
5. Blood dyscrasias
6. Intrauterine growths
9. Endocrinal disorders
648
11. Case undergoing treatment or any other serious illness_____________________________
649
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC DOUBLE BLIND CLINICAL TRIAL OF AYURVEDIC
HERBAL FORMULATION IN THE TREATMENT OF MENOPAUSAL
SYNDROME
CASE REPORT FORM II – HISTORY
(Enter a in the appropriate box)
1. Centre : ...................................
7. Address : ..............................................................................................................................
8. Educational status:
650
Chief complaint with duration in months Absent (0) Present (1) Duration
Personal History
651
Obstetric History:
Divorce/ 4
Separated
Sannipataja 7
Physical Examination
652
Absent (0) Present (1)
34. Hirsutism
35. Lymphadenopathy
36. CVS
If abnormal, details________________________________________________________
38. CNS
653
47. PER SPECULUM EXAMINATION (only in married woman)
Normal 1 Abnormal 2
If Abnormal, Specify_______________________________________________________
48. Cervicitis
49. Erosion
51. Polyp
654
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL STUDY TO STUDY THE EFFICACY OF AYURVEDIC
FORMULATION IN THE TREATMENT OF DYSFUNCTIONAL UTERINE
BLEEDING
CASE REPORT FORM III – CLINICAL ASSESMENT
(0, 1st, 2nd, 3rd, 6th and 9th Month)
1. Centre : ...................................
7. Date of Assessment :
9. Address : ..............................................................................................................................
655
15. Status of the patient:
Continuing (1)
656
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL STUDY TO STUDY THE EFFICACY OF AYURVEDIC
FORMULATION IN THE TREATMENT OF DYSFUNCTIONAL UTERINE
BLEEDING
CASE REPORT FORM IV– LABORATORY INVESTIGATIONS PARAMETERS
(For exclusion of cases at the time of screening)
1. Centre : ...................................
7. Date of Assessment :
11. TC (Cells/Cmm)___________________________________________________
12. DC: P (%) ______ P (%) ______ P (%) ______ P (%) ______ P (%) ______
657
(Investigations from Sl.No.16 to 24 will be done initially only)
i. T3 ____________________________
ii. T4 ____________________________
iv. LH ____________________________
v. FSH ____________________________
658
MULTICENTRIC OPEN CLINICAL TRIAL OF
RAJAHPRAVARTINI VATI IN KASHTARTAVA
(DYSMENORRHOEA)
659
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660
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC OPEN CLINICAL TRIAL OF RAJAHPRAVARTINI VATI IN
KASHTARTAVA (DYSMENORRHOEA)
I. BACKGROUND
Dysmenorrhoea (Kashtarthava/udavarta)1 is characterized by severe pelvic pain
occurring before or during the menstruation. Headache, nausea, vomiting, diarrhoea, lethargy,
dizziness, sweating, breast tenderness, tachycardia and heavy menstrual flow may accompany this
pain. It is classified into two, primary and secondary dysmenorrhoea. Primary Dysmenorrhoea has
no organic cause, starts usually during teenage years and coincides with the onset of ovulatory
cycles. An overall 75% of women develop Primary Dysmenorrhoea of them 15% may have
severe symptoms. Secondary Dysmenorrhoea usually arises in later reproductive age and usually
is the result of pelvic pathology.
Woman with primary dysmenorrhoea usually has regular menstrual cycles with symptoms
beginning just prior to menstruation. In the patients of dysmenorrhoea uterine contraction pressure
and resting tone are increased. The pain is thought to be secondary to ischemia due to reduction
in blood flow, which accompanies the contractions.
Secondary Dysmenorrhoea result from pelvic pathology and can occur at any age after
menarche and before menopause. Cervical Stenosis, Endometriosis, Pelvic infections, Pelvic
congestion, intrauterine birth control devices etc. can cause secondary Dysmenorrhoea.
In Ayurveda, the cardinal feature of Udavartha Yonivyvapath is said as pain during
menstruation. Based on the cardinal feature and other associated features like low back pain,relief
from pain after discharge of menstrual blood clot etc, this can be compared with primary or
secondary dysmenorrhoea. For the present study primary dysmenorrhoea cases only will be
included. To regulate uterine contractions and uterine tone many effective Ayurvedic regimen are
described in Ayurvedic classics. On clinical and experimental studies these drugs are also found
effective. For the present study Rajahpravartini vati, a well known and safe classical
Ayurvedic drug has taken up for the study.
References
1. Ambikadutta Shastri, 1972, Sushruta Samhita, Ayurveda tatwa pradeepika, Hindi Commentary,
Chowkamba Sanskrita Series, Varanasi.
2. Priyavat Sharma - Dravyaguna Vignana, Chowkamba Sanskrita Series, Varanasi.
3. Vagbhata, 1976 Astanga Samgraha, Sutra sthana, Telugu Academy, Hyderabad.
4. Ayurvedic formulary of India, Part-1, Department of AYUSH, Ministry of Health & Family
Welfare, Government of India
661
Owing to the gravity of the situation, need is felt for search of safe/effective Ayurvedic oral
dosage forms to reduce pain during menstrual period. Keeping the gravity of the situation and the
public health needs in view, the council intends to initiate scientific studies on well known and safe
classical Ayurvedic formulation Rajahpravartini vati, which is being successfully prescribed by
Ayurvedic physicians without any side effects since centuries. The formulation has been
standardized after formulating SOPs besides safety / toxicity evaluation.
The objective of current study is to assess clinical safety and efficacy through measurable
objective parameters.
II. OBJECTIVES
1) To observe the effect of Rajahpravartini vati in the management of menstrual pain of
dysmenorrohoea subjects.
2) Observe the clinical safety of on Rajahpravartini vati in dysmenorrohoea Subjects
III. CENTRES
662
The drug will be started from 5th day of
the menstrual cycle
Design of the Study : Open trial
Total period of the study : 1 year (recruitment of Subjects upto the
end of 6th month, continuation of trial
therapy till end of 8 th month, last 4
months for compilation of data and
statistical analysis)
V. CRITERIA FOR INCLUSION
1. Age between 16-35 years.
2. Painful menstruation for at least 3 consecutive cycles with regular menstrual cycles having
normal bleeding phase. (21- 35 days is the normal menstrual cycle)
3. Not associated with any organic Reproductive system abnormalities (Excluded clinically
and Radiological)
VI. CRITERIA FOR EXCLUSION
1. Cases of Secondary dysmenorrhoea
2. Pain abdomen associated with Excessive Bleeding Per vagina
3. Associated with leomyoma (Fibroid) of Uterus, Ovarian Cyst, Endometriosis (Excluded
Clinically and Radiological)
4. Associated with pelvic inflammatory disease, Hydrosalpinx (Excluded Clinically and
Radiological)
5. Associated with any serious systemic disorders likely to influence menstrual cycle
6. History of malignancy of pelvic organs
7. History of Hypo and Hyper Thyroidism
8. Women using an IUD/ Oral Contraceptive Pills (OCP)
9. Diabetes mellitus
10. Hypertension
VII. CRITERIA FOR WITHDRAWAL
During the course of the trial treatment, if any serious condition or any serious adverse
events which requires urgent treatment or if patients herself want to withdraw from the study, such
subjects may be withdrawn from the trial.
663
VIII. ROUTINE EXAMINATION AND ASSESSMENT
The full details of screening, history and physical examination of the subjects will be
recorded as per case record form I & II. Clinical, physiological and Laboratory assessment in
form III at 0, 30th (5th day of menstruation), 60th (5th day of menstruation) and 90th day (5th day
of menstruation) and laboratory investigations in forms IV will be done at 0 and 90th days.
IX. CRITERIA FOR ASSESSMENT
The changes in the subjective and objective parameters before and after the treatment shall
be considered for assessment of the safety and efficacy the drug. The safety parameters (liver and
kidney function) will be assessed at 0 and 90th day.
X. STATISTICAL ANALYSIS:
Data on clinical symptoms and objective tests before and after the treatment will be
tabulated and analyzed using appropriate statistical tools. However the data of each case will have
to be communicated on completion of trial therapy to the Statistical Officer of CCRAS through e-
mail (ccras_stat@nic.in).
XI. TRIAL MONITORING AND DATA ANALYSIS:
The progress of the trial will be monitored by field visits by monitoring unit of CCRAS.
Data analysis will be undertaken at the Monitoring Unit of CCRAS.
XII. ETHICAL REVIEW:
A. Institutional Ethical Committee (IEC): The proposal will be placed before Institutional Ethical
Committee (IEC) of trial center for getting clearance certificate before the project is
initiated. Patient’s information sheet and informed consent form will be submitted along
with project proposal for approval by IEC.
B. Data and safety monitoring board: A Data and safety monitoring board (DSMB) at Hqrs
will carefully monitor the data and side effects during the period of study and put in a
place where by prompt reporting of adverse events occur and take appropriate steps in
case of any adverse events occur. The data will be reviewed for every 20 participants
included into the study and administered the trial drugs. The research team will report
immediately to the PI and Data Monitoring Board for any life threatening conditions
whether they are perceived to be study related or not. The Board decides whether the
adverse effects warrant discontinuation of the study protocol. Protocols will be written and
approved for the treatment of study related adverse events
XIII. TRAVELLING EXPENSES FOR RESEARCH SUBJECTS
A consolidated amount of -------- per visit i.e., on the 1st day of recruitment after
screening, 1st, 2nd, 3rd month (4 times)
664
XIV. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
Short-term two-day training will be provided to the Investigators involved in the
multicentric trial at CCRAS Hqrs. New Delhi. The investigators will be detailed about the clinical
trial conduct and laboratory procedures in order to maintain the uniformity.
XV. LABORATORY INVESTIGATIONS
The Laboratory Investigations (Haematological /Biochemical, etc.), which are not available
at research Institutes should be conducted at identified reputed labs /Government Institutes under
intimation to this Council following codal formalities.
665
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CERTIFICATE BY INVESTIGATOR
WRITTEN INFORMED CONSENT FORM
I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature of the subject: ______________
Name: ____________________________
CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending physician, the purpose of the
clinical trial and the nature of drug treatment and follow-up, including the laboratory investigations
to be performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so. I am willing to undergo any risk for inclusion in
this study.
I, exercising my free power of choice, hereby give my consent to be included as a subject
in the clinical trial on “MULTICENTRIC OPEN CLINICAL TRIAL OF
RAJAHPRAVARTINI VATI IN KASHTARTAVA (DYSMENORRHOEA)”
666
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC OPEN CLINICAL TRIAL OF RAJAHPRAVARTINI VATI IN
KASHTARTAVA (DYSMENORRHOEA)
PATIENT INFORMATION SHEET
667
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC OPEN CLINICAL TRIAL OF RAJAHPRAVARTINI VATI IN
KASHTARTAVA (DYSMENORRHOEA)
CASE REPORT FORM I – SCREENING
BEFORE TREATMENT
(Enter a in the appropriate box)
1. Centre : ...................................
5. Address : Permanent postal address with phone number & E-mail if any.
..............................................................................................................................
..............................................................................................................................
668
13. Assoicated with pelvic inflammatory disease, Hydrosalpinx
19. Hypertension
(A subject is suitable for enrollment in the trial, if points 6 to 9 are YES and points 10
to 19 are NO)
If enrolled:-
Date: ___________________
If ‘Yes’ to 6 – 9 and ‘No’ to 10 – 19 above, recruit the subject for the trial, if recruited, subject
serial No: _ _ _ _ _ _ _ _ _ _ _ _
669
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC OPEN CLINICAL TRIAL OF RAJAHPRAVARTINI VATI IN
KASHTARTAVA (DYSMENORRHOEA)
CASE REPORT FORM II – HISTORY
(Enter a in the appropriate box)
1. Centre : ...................................
5. Address : Permanent postal address with phone number & E-mail if any.
..............................................................................................................................
..............................................................................................................................
1). Education:
3). Family Income per month in Rs: ______________ Income per capita in Rs: __________
4. Christian 5. Others
670
5). Working Status: 1. Not gainfully employed 2. Casual worker
Hypertension: Diabetes:
1. Menarche:
3. Consanguineous: Yes/No
671
10). PERSONAL HISTORY:
1. Pain abdomen
2. Low backache
5. Constipation
6. Giddiness
7. Breast tenderness
8. Diarrhoea
9. Headache
10. Fainting
672
Medication:
PHYSICAL EXAMINATION
4. Height (cm)_________
11. Pallor
12. Koilonychia
13. Lymphadenopathy
15. CNS
673
16. DIGESTIVE SYSTEM
Liver
Spleen
a) Anubandhya dosha
b) Anubandha dosha
c) Avaraka dosha
d) Kasheena dosha
674
Meda Asthi Majja
Shukra Oja
Shukra Oja
675
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC OPEN CLINICAL TRIAL OF RAJAHPRAVARTINI VATI IN
KASHTARTAVA (DYSMENORRHOEA)
CASE REPORT FORM – III
PERIODICAL OBSERVATION AND CLINICAL ASSESSMENT
(On 0 Day, 5th day of menstruation)
(Enter a in the appropriate box)
1. Centre : ...................................
5. Address : Permanent postal address with phone number & E-mail if any.
..............................................................................................................................
..............................................................................................................................
5). Constipation
6). Giddiness
8). Diarrhoea
676
9). Headache
10). Fainting
If yes, specify____________________________________________________________
677
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC OPEN CLINICAL TRIAL OF RAJAHPRAVARTINI VATI IN
KASHTARTAVA (DYSMENORRHOEA)
CASE REPORT FORM III
PERIODICAL OBSERVATION AND CLINICAL ASSESSMENT
(1st month, 5th day of menstruation)
(Enter a in the appropriate box)
1. Centre : ...................................
5. Address : Permanent postal address with phone number & E-mail if any.
..............................................................................................................................
..............................................................................................................................
1. Pain abdomen
2. Low backache
5. Constipation
6. Giddiness
7. Breast tenderness
8. Diarrhoea
678
9. Headache
10. Fainting
If yes, specify____________________________________________________________
13. Nausea
14. Diarrhoea
Continuing (1)
679
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC OPEN CLINICAL TRIAL OF RAJAHPRAVARTINI VATI IN
KASHTARTAVA (DYSMENORRHOEA)
CASE REPORT FORM III
PERIODICAL OBSERVATION AND CLINICAL ASSESSMENT
(2nd month, 5th day of menstruation)
(Enter a in the appropriate box)
1. Centre : ...................................
5. Address : Permanent postal address with phone number & E-mail if any.
..............................................................................................................................
..............................................................................................................................
1. Pain abdomen
2. Low backache
5. Constipation
6. Giddiness
7. Breast tenderness
8. Diarrhoea
680
9. Headache
10. Fainting
If yes, specify____________________________________________________________
13. Nausea
14. Diarrhoea
Continuing (1)
681
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC OPEN CLINICAL TRIAL OF RAJAHPRAVARTINI VATI IN
KASHTARTAVA (DYSMENORRHOEA)
CASE REPORT FORM III
PERIODICAL OBSERVATION AND CLINICAL ASSESSMENT
(3rd month, 5th day of menstruation)
(Enter a in the appropriate box)
1. Centre : ...................................
5. Address : Permanent postal address with phone number & E-mail if any.
..............................................................................................................................
..............................................................................................................................
1. Pain abdomen
2. Low backache
5. Constipation
6. Giddiness
7. Breast tenderness
8. Diarrhoea
682
9. Headache
10. Fainting
If yes, specify____________________________________________________________
13. Nausea
14. Diarrhoea
Continuing (1)
683
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC OPEN CLINICAL TRIAL OF RAJAHPRAVARTINI VATI IN
KASHTARTAVA (DYSMENORRHOEA)
(On Day 0)
CASE REPORT FORM – IV PERIODICAL OBSERVATION AND
LABORATORY ASSESSMENT
CCRAS MCT : 09 - 1
1. Centre : ...................................
5. Address : Permanent postal address with phone number & E-mail if any.
..............................................................................................................................
..............................................................................................................................
6. Date of Assessment :
7. Investigations: Blood:
684
9). Blood Sugar PP _____________________
Microscopic: _____________________
685
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC OPEN CLINICAL TRIAL OF RAJAHPRAVARTINI VATI IN
KASHTARTAVA (DYSMENORRHOEA)
(On 90th Day)
CASE REPORT FORM – IV PERIODICAL OBSERVATION AND
LABORATORY ASSESSMENT
(Enter a in the appropriate box)
CCRAS MCT : 09 - 1
1. Centre : ...................................
5. Address : Permanent postal address with phone number & E-mail if any.
..............................................................................................................................
..............................................................................................................................
6. Date of Assessment :
7. Investigations: Blood:
686
8). PCV (%) _____________________
Microscopic: _____________________
18).USG _____________________
687
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
DRUG COMPLIANCE REPORT FORM – I
MULTI CENTRIC OPEN CLINICAL TRIAL OF RAJAHPRAVARTINI VATI IN
KASHTARTAVA (DYSMENORRHOEA)
(To be translated into local language)
(To be filled by the trial participant)
(To be issued on 1st visit – 0 day and taken back on 2nd visit –30th day)
Day Date Morning dose (around 9 AM) Evening dose (around 9 PM)
Please put Please enter Please put Please enter
mark after the time mark after the time
taking the taking the
medicine medicine
1.
2.
3.
4.
5.
688
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
23.
24.
25.
26.
27.
28.
29.
30.
689
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
DRUG COMPLIANCE REPORT FORM – I
MULTI CENTRIC OPEN CLINICAL TRIAL OF RAJAHPRAVARTINI VATI IN
KASHTARTAVA (DYSMENORRHOEA)
(To be translated into local language)
(To be filled by the trial participant)
(To be issued on 2nd visit – 31 day and taken back on 3nd visit –60th day)
Day Date Morning dose (around 9 AM) Evening dose (around 9 PM)
Please put Please enter Please put Please enter
mark after the time mark after the time
taking the taking the
medicine medicine
1.
2.
3.
4.
5.
690
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
23.
24.
25.
26.
27.
28.
29.
30.
691
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTI CENTRIC OPEN CLINICAL TRIAL OF RAJAHPRAVARTINI VATI IN
KASHTARTAVA (DYSMENORRHOEA)
DRUG COMPLIANCE REPORT FORM – I
(To be translated into local language)
(To be filled by the trial participant)
(To be issued on 3st visit – 61 day and taken back on 3nd visit –90th day)
Day Date Morning dose (around 9 AM) Evening dose (around 9 PM)
Please put Please enter Please put Please enter
mark after the time mark after the time
taking the taking the
medicine medicine
1.
2.
3.
4.
5.
692
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
23.
24.
25.
26.
27.
28.
29.
30.
693
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTI CENTRIC OPEN CLINICAL TRIAL OF RAJAHPRAVARTINI VATI IN
KASHTARTAVA (DYSMENORRHOEA)
RECEIPT
694
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTI CENTRIC OPEN CLINICAL TRIAL OF RAJAHPRAVARTINI VATI IN
KASHTARTAVA (DYSMENORRHOEA)
CASE RECORD FORM V-CONSOLIDATED DATA ON PERIODICAL
OBSERVATIONS
(Enter a in the appropriate box)
1. Centre : ...................................
4. Name ......................................................................................................................................
695
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTI CENTRIC OPEN CLINICAL TRIAL OF RAJAHPRAVARTINIVATI IN
KASHTARTAVA CDYSMENORRHOEA (IRON DEFICIENCY ANAEMIA)
CASE RECORD FORM V-CONSOLIDATED DATA ON PERIODICAL
OBSERVATIONS
(Enter a in the appropriate box)
1. Centre : ...................................
4. Name ......................................................................................................................................
696
18. Burning sensation in
abdomen
Nausea
Diarrhoea
Skin rashes
19. TC (Cells/Cmm.)
20. DCLLLL P _____% P _____% P _____%
L _____% L _____% L _____%
E _____% E _____% E _____%
M_____% M_____% M_____%
B _____% B _____% B _____%
21. ESR (mm / 1st hour.)
22. Peripheral smear of
blood
23. M.C.H.C. (%)
697
7. MENSTRUAL DIARY
698
Adverse Reactions
(i) Burning sensation in
abdomen
(ii) Nausea
(iii) Diarrhoea
(iv) Skin rashes
Continuing (1)
699
Blank
700
CARDIOVASCULAR SYSTEM
SECTION - XI
Blank
702
RANDOMIZED DOUBLE BLIND CONTROLLED
CLINICAL TRIAL OF AYUSH-HT IN ESSENTIAL
HYPERTENSION
703
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704
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
RANDOMIZED DOUBLE BLIND CONTROLLED CLINICAL TRIAL OF
AYUSH-HT IN ESSENTIAL HYPERTENSION
I. BACKGROUND
Hypertension is the largest risk factor for cardio-vascular disease. This condition may be
comparable with Raktachapa or Vyanabala Vaishamya1 in Ayurveda. This risk is unevenly
distributed because it is also dependent on the number and extent of concomitant risk factors.
Definition: Criteria for the diagnosis of hypertension in various age groups as defined by
7 Joint National Committee Report is as follows:
th
References
1. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation and
Treatment of High Blood Pressure. JAMA 2003; 289(19): 2560-2572.
2. Gordon H. Williams Hypertension vascular disease page 1414-29, Harrison’s Principle of Internal
Medicine, Vol.-I, 15th Edition.
3. Dwiwedi S. Aggarwal MP: Antianginal & Cardioprotective effects of T. Arjuna: An indigenous
drug in coronary Artery disease. J. Ass. Phys. India 1994: 42: 287-289.
4. P.K. Gupta & R.H. Singh: A study on the effect of vaca in cases of essential hypertension and
IHD J.R.A.S. Vol.XVI No.3-4 (1995) PP 93-101.
5. P.V. Sharma Dravya Guna Vigyan 2nd part. Page 31-32.
705
In more than 95% of cases, aetiology of hypertension is unknown. Such patient is
diagnosed as essential hypertension. Secondary hypertension results as a consequence of a
specific disease or abnormality e.g. renal disease, endocrine disorder, drugs, pregnancy.
There are various modern drugs available as anti-hypertensive e.g. Betablockers, ACE
inhibitors, Calcium channel blockers and diuretics but these drugs have side effects and most of
these are not cost effective. Hence, the search for potent safe and cost effective Ayurvedic anti-
hypertensive drugs is exxential.
Ayurvedic drugs like Arjuna, Vacha, Punarnava & Sarpagandha possess anti hypertensive
and cardioprotective effect.
II. OBJECTIVE
To study the effect of Ayurvedic drugs Ayush-HT in essential hypertension.
III. CENTRES
Identify Center of CCRAS
IV. SAMPLE SIZE AND METHODS
Trial drug : 50 cases
Control : 50 cases
Total Sample Size : 100 at each centre
Level of study : OPD
Drug/Dosage/Duration
1. Trial drug: Ayush-HT draggee 750 mg. (Extract of equal parts of Arjuna +
Punarnava + Vacha + Sarpagandha)
Dose: One draggee BD with water after meal.
Duration – Six months (6 months follow up with drug in cases showing control in
Hypertension after 6 months of treatment)
2. Control drug: Hydrochlorothiazide 25 mg. OD with water after the breakfast for
six months. (Control drug will be made similar to trial drug and one placebo
draggee will be prescribed after dinner)
All patients included into the study will be advised to take prescribed diet regimen & light
exercise as per given along with patients information sheet.
Design of the study – Randomized Double Blind Control Clinical trail
706
Duration of the study – six months (6 months follow up with drug in cases showing
control in Hypertension after 6 months of treatment).
Total duration: will be three years to complete the trial.
V. CRITERIA FOR INCLUSION
1. Diagnosed patients of essential hypertension of duration < one year without taking any
anti-hypertensive medication for at least one month
S.B.P. < 160 mm. Hg. and >= 140 mm Hg.
D.B.P. < 100 mm. Hg. and >= 90 mm. Hg.
2. Age between 35 years to 60 years
VI. CRITERIA FOR EXCLUSION
1. Patient below 35 years and above 60 years of age.
2. Patients with
S.B.P. >= 160 mm. Hg.,<140 mm Hg
D.B.P. >= 100 mm. Hg. and < 90 mm. Hg
3. Patient receiving on anti hypertensive drug
4. Complicated hypertensive cases e.g. Nephropathy and left ventricular hypertrophy, heart
block, congestive heart failure, coronary artery disease and retinopathy
5. Patients suffering with Diabetes
6. Accelerated and malignant hypertension.
7. Patient taking steroids oral contraceptive pills, oestrogen replacement therapy or NSAID
groups of drug.
8. Pregnant women or planning pregnancy with in six months.
9. Patient with severe other illness hepatic/renal failure.
10. Secondary hypertension.
VII. CRITERIA FOR WITHDRAWAL
During the course of the trial treatment, if any serious condition develops/symptoms
aggravates due to increase in S.B.P. and D.B.P. which requires urgent treatment , such subjects
may be withdrawn from the trial and managed by the Principal Investigator accordingly.
707
VIII. ROUTINE EXAMINATION AND ASSESSMENT
The full details of history and physical examination of the patients will be recorded as per the
proforma (Forms I & II). Clinical assessment will be done fortnightly during the treatment period and
follow up period (Form III). The laboratory investigations will be recorded before treatment period,
at the end of three months, end of the treatment period and end of the follow up.
IX. ASSESSMENT OF RESULTS
Adequate Blood pressure control i.e. D.B.P. below 90 mm Hg. and S.B.P. below 140
mm. Hg. on three successive readings will be considered as significant outcome of the treatment.
X. STATISTICAL ANALYSIS
Data on clinical symptoms, physiological parameters and laboratory parameters will be
tabulated & analyzed using appropriate statistical methods.
XI. TRIAL MONITORING AND DATA ANALYSES
The monitoring of progress of the trial and data analysis will be undertaken by CCRAS
HQrs., New Delhi.
XII. ETHICAL REVIEW
Each Institutional Ethical Committee (IEC) of participating Centre’s should give clearance
certificate before the project is initiated. Patient’s information sheet and informed consent form
should be submitted alongwith project proposal for approval by IEC. Both should be maintained
in duplicate with
XIII. TRAVELING EXPENSES FOR RESEARCH SUBJECTS
A consolidated amount of Rs. ——————— per visit will be paid to subject on
every visit.
XIV. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
Short-term two-day training will be provided to the Investigators and Laboratory
personnel involved in the multi-centric trial at CCRAS Hqrs. and Central Research Institute (Ay.),
New Delhi. The investigators and technicians will be detailed about the clinical trial conduct and
laboratory procedures in order to maintain the uniformity.
XV. LABORATORY INVESTIGATIONS
The Laboratory Investigations (Pathological/Biochemical, etc.), which are not available at
research Institutes should be conducted at identified reputed labs /Government Institutes under
intimation to this Council following codal formalities.
708
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
WRITTEN INFORMED CONSENT FORM
CERTIFICATE BY INVESTIGATOR
I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature of the subject: ______________
Name: ____________________________
CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending physician, the purpose of the
clinical trial and the nature of drug treatment and follow-up, including the laboratory investigations
to be performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so. I am willing to undergo any risk for inclusion in
this study.
I, exercising my free power of choice, hereby give my consent to be included as a subject
in the clinical trial on “Randomized double blind controlled clinical trial of ayush-HT in
essential hypertension”.
709
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
RANDOMIZED DOUBLE BLIND CONTROLLED CLINICAL TRIAL OF
AYUSH-HT IN ESSENTIAL HYPERTENSION
PATIENT INFORMATION SHEET
710
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
RANDOMIZED DOUBLE BLIND CONTROLLED CLINICAL TRIAL OF
AYUSH-HT IN ESSENTIAL HYPERTENSION
CASE REPORT FORM I - SCREENING
(Before Treatment)
(Enter a in the appropriate box)
1. Centre : ...................................
5. Address : ..............................................................................................................................
..............................................................................................................................
4. Patients with
711
7. Patients suffering with Diabetes mellitus
9. Secondary hypertension.
712
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
RANDOMIZED DOUBLE BLIND CONTROLLED CLINICAL TRIAL OF
AYUSH-HT IN ESSENTIAL HYPERTENSION
CASE REPORT FORM II – HISTORY
1. Centre : ...................................
5. Address : ..............................................................................................................................
8. Educational status:
Chief complaint with duration (if any) in days Yes (1) No (0) Duration
(in days)
11. Giddiness
12. Irritability
713
13. Fatigue
15. Headache
22. Diuretics
23. Others
Personal History:
28. Constipation
Hard Work
714
Addiction Yes (1) No (0)
30. Smoking
31. Tobacco
32. Alcohol
Sannipataj
32. Hypertension:
Parent:
Siblings:
33. Hypercholesterolemia
Parent :
Siblings:
715
b) Gait Normal Abnormal
h) Pallor
i) Jaundice
j) Koilonychia
k) Lymphadenopathy
l) Edema
b) CNS
c) Digestive system
d) Uro-genital system
716
e) Respiratory system
i) Liver
ii) Spleen
g) Eye examination
717
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
RANDOMIZED DOUBLE BLIND CONTROLLED CLINICAL TRIAL OF
AYUSH-HT IN ESSENTIAL HYPERTENSION
CASE RECORD FORM III -PERIODICAL OBSERVATION AND ASSESSMENT
(Fortnightly during treatment period and follow up)
1. Centre : ...................................
5. Address : ..............................................................................................................................
Clinical Parameters
8. Giddiness
9. Irritability
10. Fatigue
12. Headache
718
b. Objective
719
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
RANDOMIZED DOUBLE BLIND CONTROLLED CLINICAL TRIAL OF
AYUSH-HT IN ESSENTIAL HYPERTENSION
CASE REPORT FORM IV-A – LABORATORY INVESTIGATIONS
(Enter a in the appropriate box)
(Before treatment, end of the 3rd month and after the treatment)
1. Centre : ...................................
5. Address : ..............................................................................................................................
Urine Examination
Routine
8. Sugar: __________________
9. Albumin __________________
Microscopic
720
Stool examination
Microscopic
Blood
LIPID PROFILE
721
LIVER FUNCTION TEST
Serum Bilirubin
Serum Electrolytes
Other investigations
45. X-ray chest (PA View) (only at the beginning of study) _____________________________
722
Diet Regimen:
Fat < 30% of calorie (Saturated fat < 10% Polyunsaturated fat < 8% of total diet)
Saturated fat e.g. Ghee, Vanaspati, Dalda, Palm, Coconut oil, egg and meet These contain highly
saturated fat and cholesterol.
Sun flower oil, Soyabean oil, Olive oil contain unsaturated fat it should be taken 3 small tea
spoonful per day.
Whole Cereal: 90 gm daily. Example old Sama rice, wheat, java, with husk.
Vegetable: 250 gm daily. Example Pumpkin, methi, padwal, karaila, and beans.
Non polished Dal: 75 gm. Daily. Example Moong, Masoor, Chana, Arhar.
Fruits: 250 gm. Daily.Example all seasonal like mango, apple, cucumber, pear dhatriphal,
723
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724
PROTOCOL FOR PLACEBO CONTROLLED MULTI-
CENTRIC CLINICAL TRIAL OF AN AYURVEDIC
FORMULATION IN THE MANAGEMENT OF
CHRONIC STABLE ANGINA
725
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726
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
PLACEBO CONTROLLED MULTI-CENTRIC CLINICAL TRIAL OF AN
AYURVEDIC FORMULATION IN THE MANAGEMENT OF CHRONIC
STABLE ANGINA
I. BACKGROUND
Coronary artery disease is an important cause of morbidity and mortality. The incidence
and prevalence of the disease is gradually rising in our country and a substantial portion of adult
population is affected. Some of the Ayurvedic drugs investigated so far have shown encouraging
cardio-protective potential. The classical literature in Ayurveda has described the usefulness of
Arjuna1 and Pushkarmula2 in prevention and treatment of Hridroga (cardiac angina specially
relating to Ischaemic heart diseases). The studies on Arjuna3,4,5 and Pushkarmula,6,7,8,9,10 in many
centers have put forth the efficacy of the drug in the management of ischaemic heart disease and
has been practiced in preventive cardiology. They lower lipids in patients and prevent the increase
in lipids in experimental animals.
Keeping in view the references with the ancient classical literature of Ayurveda and the
leads obtained in the recent studies, the combination of Arjuna and Pushkarmula has been
selected for trial in prevention of cardiac risk factors in cases of Chronic Stable Angina.
References
1. Chakrapani; Chakradutta; Chaukhamba Publication, Varanasi; 3rd Edition, Hridroga (Chapter 21),
verses 8 & 9
2. Charaka Samhita; Chaukhamba Publication, Varanasi; 2nd Edition; Sutra Sthana, Chapter 25,
Verses 40 and Chikitsa sthana, Chapter-26, verses 84-86.
3. Colabawalla, H.M., An Evaluation of Cardio-tonic and other properties of Terminalia arjuna,
Indian Heart.J.3;205-30, 195
4. Singh, N.et.al.: Mechanism of Cardiovascular response of Terminalia arjuna, Ind.J.Pharmacol. II
(I) : 33, 1979
5. Ojha J.K. et.al., I.racemosa, as Hypolipidaemia agent (an experimental and clinical study), Indian
J.Pharm.39 (6);176, 1977
6. Singh, Ramji, et.al. Pushkara guggulu - an Antianginal and Hypolipidaemic Agent in Coronary
Heart Disease (CHD), JRAS, Vol.XII, No.1-2, Pp-1-18 (1990)
7. Singh, N.et.al.; Pharmacological studies on I.racemosa, J.Res. Indian Med.Yoga and Homoeo
11(3):25-32, 1976.
8. Dwivedi S, Agarwal MP. Antianginal and cardioprotective effects of Terminalia arjuna: An
indigenous drug in coronary artery disease.J Ass Phys India 1994; 42:287-289.
9. Bharani A, Ganguli A, Bhargava KD. Salutary effect of Terminalia arjuna in patients with severe
refractory heart failure. Int. Journal Cardiol 1995;49:191-99.
10. Dwivedi S, R. Jouhari.Beneficial effects of Terminalia arjuna in Coronary artery disease: Indian
Heart J.; 49:507-10.
727
II. OBJECTIVE
Effect of Arjuna barks powder and aqueous extracts of Pushkarmula on Chronic Stable
Angina.
III. CENTRES
CCRAS identified centers.
IV. SAMPLE SIZE AND METHODS
Sample Size : 100 (50 patients in each group)
Run-in Period : One week
Groups : Two (Trial and Control)
Drug/Dosage/Duration
Group-I Trial drug
a). Drug : Arjuna twaka (bark of Terminalia arjuna W. & A.) and
Pushkarmula (root of Inula racemosa Hook. f.) in
capsule form (each capsule containing Arjuna bark
powder 500 mg. and aqueous extract of Pushkarmula
derived from 500 mg. of crude drug).
b). Dosage : Three capsule of 500 mg each twice a day.
c). Duration : 90 days
Group II- Control drug (Control drug will be made similar to trial drug)
Design of the study : Randomized Double–blind Placebo controlled study.
Duration of : One week run-in period and three months drug therapy
the study with follow up for three months without drug.
Period of Study : Period of study will be six months for each case. Total
duration will be two and half years to complete the trial at
each Centre.
V. CRITERIA FOR INCLUSION
1. Age more than 35 years of either sex
2. Diagnosed cases of Chronic Stable Angina.
3. TMT positive cases
728
VI. CRITERIA FOR EXCLUSION
1. Age below 35 years
2. Recent M.I. less than three months
3. Patients with conduction problem
4. Patients with uncontrolled hypertension
5. Unstable Angina
6. Serious concomitant disease of liver and/or kidney
7. Any malignancy
8. Undergoing treatment for any other serious illness
VII. CRITERIA FOR WITHDRAWAL
If during the course of the trial treatment, subjects shows the following:
1. any serious toxicity for intolerance,
2. acute myocardial infarction,
3. stable angina progressing to unstable angina and/or,
4. undergoing Coronary re-vascularisation
Subject will be withdrawn from the study. If any other serious condition develops during
the course of study, which requires urgent treatment, such subjects will also be withdrawn from the
trial and managed by the Principal Investigator accordingly.
VIII. ROUTINE EXAMINATION AND ASSESSMENT
The full details of history and physical examination of the patients will be recorded as per
the Performa (Forms I & II). Clinical assessment will be done before drug administration (0),
after one week of Run-in period, every six weeks during treatment and at the end of follow up
(Form III) (after three months of completion of treatment). The laboratory investigations and TMT
will be recorded before drug administration, after one week of Run-in period and after completion
of treatment (Form-IV). All the patients will be provided a ‘Diary of Events’ for keeping record
of angina attacks and consumption of nitrate tablets.
IX. STATISTICAL ANALYSIS
Data on frequency of angina, consumption of nitro-glycerin tablets, duration of exercise
tolerance on TMT (end point), time taken for 1 mm ST depression, maximum double product,
lipid profile at the end of run-in period and at the end of treatment will be analyzed using
appropriate statistical methods.
729
X. CRITERIA FOR ASSESSMENT
The assessment of progress & outcome of treatment are assessed on the basis of
improvement in the symptoms.
XI. TRIAL MONITORING AND DATA ANALYSIS
The progress of the trial will be monitored by Monitoring Unit of CCRAS Head Quarters,
New Delhi.
XII. ETHICAL REVIEW
Each participating center’s Institutional Ethical Committee (IEC) should give a clearance
certificate before the project is initiated. Patient’s information sheet and informed consent form
should be submitted along with the project proposal for approval by IEC. Both should be
maintained in duplicate with one copy given to the patient at the time of entry to the trial.
XIII. TRAVELING EXPENSES FOR RESEARCH SUBJECTS
A consolidated amount of Rs…../- per visit will be paid to subject selected for trial.
XIV. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
Short-term two-day training will be provided to the Investigators and Laboratory
personnel involved in the multi-centric trial at CCRAS Hqrs. New Delhi. The investigators and
technicians will be detailed about the clinical trial conduct and laboratory procedures in order to
maintain the uniformity.
XV. LABORATORY INVESTIGATIONS
The Laboratory Investigations (Pathological/Biochemical, etc.), which are not available at
research Institutes should be conducted at identified reputed labs /Government Institutes under
intimation to this Council about codal formalities.
730
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
PLACEBO CONTROLLED MULTI-CENTRIC CLINICAL TRIAL OF AN
AYURVEDIC FORMULATION IN THE MANAGEMENT OF CHRONIC
STABLE ANGINA
WRITTEN INFORMED CONSENT FORM
CERTIFICATE BY INVESTIGATOR
I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature of the subject: ______________
Name: ____________________________
CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending doctor, the purpose of the
clinical trial and the nature of drug treatment and follow-up, including the laboratory investigations
to be performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so.
I, exercising my free power of choice, hereby give my consent to be included as a subject
in the “Clinical trial of Arjuna and Pushkarmula in the cases of Chronic Stable Angina”.
731
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
PLACEBO CONTROLLED MULTI-CENTRIC CLINICAL TRIAL OF AN
AYURVEDIC FORMULATION IN THE MANAGEMENT OF CHRONIC
STABLE ANGINA
PATIENT INFORMATION SHEET
732
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
PLACEBO CONTROLLED MULTI-CENTRIC CLINICAL TRIAL OF AN
AYURVEDIC FORMULATION IN THE MANAGEMENT OF CHRONIC
STABLE ANGINA
CASE REPORT FORM I - SCREENING
BEFORE TREATMENT
(Enter a in the appropriate box)
1. Centre : ...................................
6. Address : ..............................................................................................................................
..............................................................................................................................
7. Uncontrolled hypertension
8. Unstable Angina
733
9. Serious concomitant disease of liver / kidney
10. Malignancy
734
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
PLACEBO CONTROLLED MULTI-CENTRIC CLINICAL TRIAL OF AN
AYURVEDIC FORMULATION IN THE MANAGEMENT OF CHRONIC
STABLE ANGINA
CASE REPORT FORM II – HISTORY
(Enter a in the appropriate box)
1. Centre : ...................................
5. Address : ..............................................................................................................................
Chief complaint with duration (if any) in days Present (1) Absent (0) Duration
If present, indicate:
Location________________________________________________________________
Radiation________________________________________________________________
Type of pain_____________________________________________________________
9. Post-prandial pain
735
History of present illness
15. Nitrates
16. Others
If yes, specify____________________________________________________________
If yes, specify____________________________________________________________
PERSONAL HISTORY
19. Constipation
Sannipataja 7
PHYSICAL EXAMINATION
General
736
SYSTEMIC EXAMINATION
Cardiovascular
31. Oedema
32. Hepatomegaly
33. Splenomegaly
RESPIRATORY
34. Crepitation
35. Rhonchi/Wheezing
737
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
PLACEBO CONTROLLED MULTI-CENTRIC CLINICAL TRIAL OF AN
AYURVEDIC FORMULATION IN THE MANAGEMENT OF CHRONIC
STABLE ANGINA
CASE REPORT FORM III – CLINICAL ASSESSMENT
(0, 1st, 7th, 13th and 25th week)
1. Centre : ...................................
7. Date of Assessment :
Clinical Parameters
8. Chest pain
If present, indicate:
Location _____________
Radiation _____________
738
13. Dyspnoea on exertion
B. Objective
739
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
PLACEBO CONTROLLED MULTI- CENTRIC CLINICAL TRIAL OF AN
AYURVEDIC FORMULATION IN THE MANAGEMENT OF CHRONIC
STABLE ANGINA
CASE REPORT FORM III A - ADVERSE EVENTS RECORD
(0, 15, 30, 45, 60, 75, 90 days)
1. Centre : ...................................
7. Address : Permanent postal address with phone number and email if any.
..............................................................................................................................
..............................................................................................................................
ADVERSE EVENTS
8. Does the patient have any symptoms with medication in trial group? Yes No
Please complete all sections & enter l approximate information in numbers in open boxes
1 2 3 4
Adverse
Experience
740
Date started
Date
Time
Date stopped
Pattern
Isolated-1
Intermittent-2
Continuous-3
Severity
Mild-1
Moderate-2
Severe-3
Serious*
Yes-1
No-2
741
Relationship
to study
medication
Unrelated-1
Possible-2
Probable-3
Unrelated: A reaction that does not follow a reasonable temporal sequence from the
administration of the drug; or a known adverse reaction pattern of the suspected drugs could
have been produced by the patients clinical stage, intermittent illness, trauma, accidents etc:
Possible: follows a reasonable temporal sequence from administration of the drug; follows a
known response pattern to the suspected drug but could have been produced by the patients
clinical stage or other modes of therapy administered to the patients;
Probable: follows a reasonable temporal sequence from administration of the drug; follows a
known response pattern to the suspected drug; that could not be reasonably explained by the
known characteristics of the patient's clinical state.
742
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
PLACEBO CONTROLLED MULTI-CENTRIC CLINICAL TRIAL OF AN
AYURVEDIC FORMULATION IN THE MANAGEMENT OF CHRONIC
STABLE ANGINA
CASE REPORT FORM IV – LABORATORY INVESTIGATIONS
('O' day, after one week of Run in period and after end of the treatment)
1. Centre : ...................................
7. Address : Permanent postal address with phone number and email if any.
..............................................................................................................................
..............................................................................................................................
8. Date of Assessment :
Blood
743
17. HDL (mg./dl) ______________
Radiological Investigations
___________________________________
Special Tests
___________________________________
{Mets-…….]
V1 V2 V3 V4 V5 V6
744
URINARY SYSTEM
SECTION - XII
Blank
746
MULTICENTRIC DOUBLE BLIND PLACEBO
CONTROLLED CLINICAL TRIAL OF AN AYURVEDIC
FORMULATION ON MUTRASHMARI
(UROLITHIASIS)
747
Blank
748
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC DOUBLE BLIND PLACEBO CONTROLLED CLINICAL
TRIAL OF AN AYURVEDIC FORMULATION ON MUTRASHMARI
(UROLITHIASIS)
I. BACKGROUND
Urinary calculi consist of aggregation of crystals and small amounts of proteins and
glycoproteins but their genesis is poorly understood. Different types of stone occur in different
parts of the world with different chemical composition. Dietary factors probably play a part in
determining the varying patterns. In developing countries, bladder stones are common particularly
in children. In industrial countries the incidence of childhood bladder stone is low and renal stones
in adults are more common. In this condition there may be urinary calculi anywhere in the urinary
tract.
Detailed descriptions concerning the etiology, clinical features and line of management of
this condition is available in classical literature of Ayurveda. The common features of presentation
are pain and obstruction to flow of urine with/without haematuria. The management of urinary
calculi is revolutionized during the last 2-3 decades. The surgical treatment, endourology and
ESWL can effectively treat/manage the existing calculi but the problem of residual fragments and
recurrence of calculi persists.
The medical treatment is effective in the management of small calculi, residual fragments
and prevention of urinary calculi. Keeping this in view various Ayurvedic drugs like Shveta Parpati,
Gokshuru, Varuna, Pashana Bheda, Kulattha and Palash Kshara prescribed in ancient Ayurvedic
texts have been studied in the management of this condition.
References
1. Sannd, B.N., Kumar, Anil and Kumar, Naresh: To evaluate the effect of Ayurvedic Drugs
Shveta Parpati with Pasana Bheda and Gokshuru in the management of Mutrashmari
(urolithiasis); JRAS, Vol.XIV, No. 3-4 , Pp.98-114, 1998.
2. Kumar, Anil and Kumar, Naresh: To evaluate the effect of Ayurvedic drugs – a herbomineral
comibiation of Shveta Parpati with Kulatha Kwatha in the management of Mutrashmari
(urolithiasis); JRAS, Vol. XVI, No.1-2, Pp.35-42, 1995.
3. Kumar, Anil and Kumar, Naresh: To evaluate the effect of Palasha Kshara in the management
of Mutrashmari (Urolithiasis); JRAS, Vol.XVI, No.1-2, Pp.43-50, 1995.
4. Singh, L.M., Shukla, J.P. and Deshpande, P.J.: Monograph on “Management of Mutrashmari
by three Ayurvedic Drugs Varuna, Kulatha and Gokshuru”, C.C.R.A.S., New Delhi, 1987.
749
Shveta Parpati with decoction of Gokshuru and ,Pashana Bhed1; Shveta Parpati with
decoction of Kulattha2; Palash Kshara3; and Varuna, Kulattha and Guggulu4 have been found quite
effective in management this condition. The present multricentric clinical trial is proposed with a
view to re-establish the efficacy of this formulation for the management of urolithiasis.
II. OBJECTIVE
To assess the efficacy of Shveta Parpati and Palash Kshara with the aqueous extract of
Kulattha, Pashana Bheda, Gokshuru in the cases of Mutrashmari (Urolithiasis).
III. CENTRES
CCRAS centers in collaboration with other centers.
IV. SAMPLE SIZE AND METHODS
Sample Size : 120 Subjects (60 subjects in each group)
Groups : Two – trial and control
Drug/Dosage/Duration : Trial drug in one group
(i) Drug : Shveta Parpati 1and Palash Kshara 2 with the
aqueous extract of Kulattha3, Pashan Bheda4 and
Gokshuru5, all in equal quantity.
(ii) Dosage : Two capsules of 500 mg each TDS
(iii) Duration : 90 days and placebo in another group.
Design of the study : Randomised Double – blind Placebo controlled
study.
Duration of the study : Three months drug therapy with follow up for nine
months without drug
Total period of study : Total one year, registration of the patients should
be done only in first fifteen months of the start of
the study.
Period of Study : Twelve months for each case. Total duration will be
two and half years to complete the trial at each
Centre.
Follow – Up : Three follow-ups will be carried out after 3rd, 6th
and 9th after completion of treatment.
750
V. CRITERIA FOR INCLUSION
1. Age: between 15 to 60 years
2. Sex: either sex
3. Radiological evidence of stone (upto 10 mm) in kidney, ureter and urinary bladder
VI. CRITERIA FOR EXCLUSION
1. Age below 15 years and above 60 years
2 Stone size more than 10 mm
2. Impacted stone
3. Gross hydronephrosis
4. Pyelonephritis
5. Diabetes mellitus
6. Malignancy
7. Impaired renal function
8. Poorly functioning kidney
9. Patients with obstruction in urinary passage.
10. Patients with known metabolic abnormality for calculus formation
11. Any other complication of calculus.
12. Patients undergoing treatment for any other serious illness
VII. CRITERIA FOR WITHDRAWAL
During the course of the trial treatment, if any serious condition develops which requires
urgent treatment such subjects may be withdrawn from the trial and managed by the Principal
Investigator accordingly.
VIII. ROUTINE EXAMINATION AND ASSESSMENT
The full details of history and physical examination of the patients will be recorded as per
the proforma (Forms I & II). Clinical assessment will be done before drug administration (0), at
the end of Ist, IInd, IIIrd months during treatment and at the end of 6th, 9th and 12th months
during follow up (Form III). The laboratory and radiological investigations will be recorded before
drug administration (0 month), at the end of treatment (3 months) and at the one year (12
months) as per proforma (Form IV)
751
IX. STATISTICAL ANALYSIS
Radiological evidence of disappearance or reduction in the size of the stone, Clinical
parameters and laboratory parameters will be analysed using appropriate statistical methods.
X. TRIAL MONITORING AND DATA ANALYSES
The progress of the trial will be monitored by Monitoring Unit of CCRAS Head quarters,
New Delhi.
XI. ETHICAL REVIEW
Each participating centre’s Institutional Ethical Committee (IEC) should give clearance
certificate before the project is initiated. Patient’s information sheet and informed consent form
should be submitted alongwith project proposal for approval by IEC. Both should be maintained
in duplicate with one copy given to the patient at the time of entry to the trial.
XII. TRAVELING EXPENSES FOR RESEARCH SUBJECTS
A consolidated amount of Rs…../- per visit i.e., on the 1st day of recruitment after
screening, 15th, 30th, 45th, 60th, 75th and 90th days (7 times).
XIII. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
Short-term two-day training will be provided to the Investigators and Laboratory
personnel involved in the multi-centric trial at CCRAS Hqrs. and Central Research Institute (Ay.),
New Delhi. The investigators and technicians will be detailed about the clinical trial conduct and
laboratory procedures in order to maintain the uniformity.
XIV. LABORATORY INVESTIGATIONS
The Laboratory Investigations (Pathological/Biochemical, etc.), which are not available at
research Institutes should be conducted at identified reputed labs /Government Institutes under
intimation to this Council following codal formalities.
752
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC DOUBLE BLIND PLACEBO CONTROLLED CLINICAL
TRIAL OF AN AYURVEDIC FORMULATION ON MUTRASHMARI
(UROLITHIASIS)
PATIENT CONSENT FORM
CERTIFICATE BY INVESTIGATOR
I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature of the subject: ______________
Name: ____________________________
CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending doctor, the purpose of the
clinical trial and the nature of drug treatment and follow-up, including the laboratory investigations
to be performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so.
I, exercising my free power of choice, hereby give my consent to be included as a subject
in the “Clinical trial of Shveta Parpati, Palash Kshara, Kulattha, Pashana Bheda and Goksuru in
the cases of Mutrashmari (urolithiasis)”.
753
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC DOUBLE BLIND PLACEBO CONTROLLED CLINICAL
TRIAL OF AN AYURVEDIC FORMULATION ON MUTRASHMARI
(UROLITHIASIS)
PATIENT INFORMATION SHEET
754
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC DOUBLE BLIND PLACEBO CONTROLLED CLINICAL
TRIAL OF AN AYURVEDIC FORMULATION ON MUTRASHMARI
(UROLITHIASIS)
CASE REPORT FORM I - SCREENING
BEFORE TREATMENT
(Enter a in the appropriate box)
1. Centre : ...................................
6. Address : ..............................................................................................................................
..............................................................................................................................
2. Either Sex
6. Gross hydronephrosis
7. Pyelonephritis
8. Diabetes mellitus
755
9. Malignancy
756
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC DOUBLE BLIND PLACEBO CONTROLLED CLINICAL
TRIAL OF AN AYURVEDIC FORMULATION ON MUTRASHMARI
(UROLITHIASIS)
CASE REPORT FORM II – HISTORY
(Enter a in the appropriate box)
1. Centre : ...................................
9. Educational status:
10. Occupation
Chief complaints with duration in days Absent (0) Present (1) Duration
10. Haematuria
757
Absent (0) Present (1) Duration
11. Crystalluria
16. Others
If yes specify____________________________________________________________
PERSONAL HISTORY
23. Fluid intake Less than one ltr.(1) 1-2 ltr. (2)
Sannipataja 7
758
25. Addiction No (0) Yes (1)
If yes, Specify____________________________________________________________
PHYSICAL EXAMINATION
33. C.N.S.
Uro-Genital system
37. Prostate
759
Palpable (1) Non-palpable (2)
38. Kidney
39. Bladder
760
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC DOUBLE BLIND PLACEBO CONTROLLED CLINICAL
TRIAL OF AN AYURVEDIC FORMULATION ON MUTRASHMARI
(UROLITHIASIS)
CASE REPORT FORM III – CLINICAL ASSESSMENT
(0, 1, 2, 3, 6, 9 & 12th months)
1. Centre : ...................................
2. Code No. (of clinical trial) :
3. Subject Name : ....................................................................................................................
4. Sr. No. of the Subject : .......................................................................................................
5. Gender Male (1) Female (2)
6. Date of Birth : Age (in yrs.) :
7. Date of Assessment :
8. Month of Assessment :
Clinical Symptoms Present (1) Absent (0)
9. Intermittent dull or colickly flank pain
10. Haemturia
11. Crystalluria
12. Turbid urination
13. Intermittent flow of urine
14. Increased frequency
15. Burning micturition
16. Other if any
If yes, specify____________________________________________________________
761
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
PROTOCOL FOR MULTICENTRIC DOUBLE BLIND PLACEBO
CONTROLLED CLINICAL TRIAL OF AN AYURVEDIC FORMULATION ON
MUTRASHMARI (UROLITHIASIS)
CASE REPORT FORM III A - ADVERSE EVENTS RECORD
(0, 15, 30, 45, 60, 75, 90 days)
1. Centre : ...................................
7. Date of Assessment :
ADVERSE EVENTS
1. Does the patient have any symptoms with medication in trial group? Yes No
Please complete all sections & enter l approximate information in numbers in open boxes
1 2 3 4
Adverse
Experience
762
Date started
Date
Time
Date stopped
Pattern
Isolated-1
Intermittent-2
Continuous-3
Severity
Mild-1
Moderate-2
Severe-3
Serious*
Yes-1
No-2
763
Relationship
to study
medication
Unrelated-1
Possible-2
Probable-3
Unrelated: A reaction that does not follow a reasonable temporal sequence from the
administration of the drug; or a known adverse reaction pattern of the suspected drugs could
have been produced by the patients clinical stage, intermittent illness, trauma, accidents etc:
Possible: Follows a reasonable temporal sequence from administration of the drug; follows a
known response pattern to the suspected drug but could have been produced by the patients
clinical stage or other modes of therapy administered to the patients;
Probable: Follows a reasonable temporal sequence from administration of the drug; follows a
known response pattern to the suspected drug; that could not be reasonably explained by the
known characteristics of the patient's clinical state.
764
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC DOUBLE BLIND PLACEBO CONTROLLED CLINICAL
TRIAL OF AN AYURVEDIC FORMULATION ON MUTRASHMARI
(UROLITHIASIS)
CASE REPORT FORM IV – LABORATORY INVESTIGATIONS
(0, 1st, 3rd and 12th MONTH)
1. Centre : ...................................
7. Date of Assessment :
8. Month of Assessment :
Urine Examination
9. Routine: _______________________________
10. pH _______________________________
14. CRYSTALCASTS_______________________________
765
Hours Urine Analysis
Blood
766
Radiological Investigations
Plain X-ray (KUB)* [0, 3rd, 6th, 9th 12th Month] ____________________
Kidney
44. Size
Kidney
50. Size
51. Hyderonephrosis
767
53. Ureter Normal 1 Dilated 2
If in-significant, specify_____________________________________________________
768
VECTOR BORNE DISEASES
SECTION - XIII
Blank
770
ASSESSMENT OF THE THERAPEUTIC EFFICACY OF
CERTAIN HERBAL / HERBOMINERAL DRUGS IN
THE MANAGEMENT OF KALA-AZAR
771
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772
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF THE THERAPEUTIC EFFICACY OF CERTAIN HERBAL /
HERBOMINERAL DRUGS IN THE MANAGEMENT OF KALA-AZAR
I. BACKGROUND
The disease Kala-azar also known as Visceral Leishmaniasis is a highly fatal disease
caused by Leishmania donovani. The origin or entity of the disease may not be historic but
according to classical literature may be correlate with same of the symptoms found resembles
with ‘SATATAK JWAR’ under the group of Vishamajwara. Though the Visceral Leishmaniasis is
caused due to the bite of sandflies transporting the organism / parasite Leishmania donovani which
is not described in Ayurveda but the causative factor of ‘SATATAK JWARA’ may be correlated
with ‘Bhutabhisanga’. Then probably Leishmania donovani might have been discovered by present
era. However the sign & symptoms like spleenomegaly (Pleihavriddhi). Fever (Mandajwara).
Vishamarambha is the cardinal symptoms in ‘SATATAK JWARA’ upon which Kala-a-zar may be
taken as in prevalence with modern synonyms.
In India, man is the reservoir of infections, and parasite are readily obtainable from
peripheral blood by the sand fly (rodents and dogs are the main reservoir hosts in African venereal
leishmaniasis). Visceral Leishmaniasis may occur in epidemics and recording of epidemic outbreaks
in India goes to year 1870.
Keeping in the view and considering these above aspect, the persistent morbidity, high
mortality and high toxicity of present available modern drugs especially Pentamedin,
Amphotericin‘B’ and Sodium stibogluconate etc. and some herbo-mineral compound has been
shorted out for the management of Kala-azar and aspecting the probable results due to containing
Antimony sulphide (modern drug of choice) i.e. Srotonjana.1
Apart from this some Hepato-protective and Spleeno-protective, Heamatinic, febrifuge
herbal drugs i.e. Guduchi, Sharpunkha, Kalmegha, Rohitaka, Sakhotaka, Saptaparna, Sudarshana
and Punarnava etc. are possible suitable Ayurvedic drugs in this ailment and this project has been
selected for clinical trial.
References :
1. Pandit.Kasinath Sashtri and Dr. Gorakhanath Chaturvedi (1984) Charaka Samhita, (text with
Hindi commentary) XIIth Edition (1984), Published by Chaukabha Vidhya Bhavan, Varanasi,
India
2. Harisson’s Principles of internal medicine, Volume-1, 14th Edition, International Editions, 1998,
Published by McGraw-Hill CompaniesInc.
3. Ambika Dutta Sashtri(1989), Susruta Samhita (text with Hindi commentary), VIIth Edition
Chaukhamba Sanskrit Series Office, Varanasi
773
II. OBJECTIVE
To evaluate the efficacy of some Herbal / Herbomineral drugs in the management of Kala-
Azar.
III. CENTRE
CCRAS centers in collaboration with other centers.
IV. SAMPLE SIZE & METHODS
Sample size- 300
Groups –
Group Total Cases Drug & Dose
Group – I (Treated group) 150
Group – II (Treated group) 100
Group – III (Control group) 50 Amphotericin’B’
(Treated with modern medicines)
Allocation of the cases in each group will be made on randomize by a statistician.
Treatment: Some Herbal / Herbomineral drugs
Design of study: Open trial with standard control group.
Duration of study: 2 years ( 1 year for treatment and 1 year for follow up)
Total period of study: 2 years
774
VI. CRITERIA FOR EXCLUSION
1. Age below 10 yrs & above 60 yrs.
2. Pulmonary tuberculosis
3. Severe Jaundice / Hepatitis
4. Pregnancy / Lactating mother
5. HIV positive serology / Malignancy
6. Any other serious systemic disease.
7. Hepatic-spleenomegaly due to other diseases.
8. History of Renal disease / Cardiac disease.
X. CRITERIA OF ASSESSMENT
1. Disappearance of parasite (L.D. bodies)
2. Absence of Pyrexia & other clinical symptoms.
3. Negative L.D. bodies in bone marrow / spleen aspirate found at the end of
treatment (clinical improvement), smear stained for demonstration of Leishmania
donoveni bodies (L.D. Bodies).
775
4. Culture Aspirates (for L.D. Bodies) of the following
5. Aldehyde Test
776
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF THE THERAPEUTIC EFFICACY OF CERTAIN HERBAL /
HERBOMINERAL DRUGS IN THE MANAGEMENT OF KALA-AZAR
WRITTEN INFORMED CONSENT FORM
CERIFICATE BY INVESTIGATOR
I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: …………………… Signature …………………..
Name ………………………
CONSENT BY SUBJECT
I have been informed to my satisfactory, by the attending physician, the purpose of the
clinical trial and the nature of drug treatment and follow-up, including the laboratory investigations
to be performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so.
I, exercising my free power of choice, hereby give my consent to be included as a subject
in the clinical trial on “Assessment of the Therapeutic efficacy of certain Herbal / Herbomineral
drugs in the management of Kala-azar.”
777
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF THE THERAPEUTIC EFFICACY OF CERTAIN HARBAL /
HERBOMINERAL DRUGS IN THE MANAGEMENT OF KALA-AZAR
PATIENT INFORMATION SHEET
778
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF SINGLE / COMPOUND HERBO /
HERBOMINERAL COMPOUND DRUGS IN THE MANAGEMENT OF
KALA-AZAR
CASE REPORT FORM I - SCREENING
BEFORE TREATMENT
(Enter a √ in the appropriate box)
1. Name of the Subject: …………………………………........……………………………
2. Address …………………………………………………….......……………………….
3. Centre…………………………………
4. Code No. (of clinical trial)
5. Sex: Male (1) Female (2)
6. Date of Birth: Age (in yrs.):
7. Group: Treatment Treatment Control
1. Age 10 to 60 yrs.
2. Positive Symptoms of Kala-azar (L.D. bodies)
3. Fever
4. Enlarged spleen
CRITERIA OF EXCLUSION Yes No
5. Age below 10 yrs and above 60 yrs.
. Pulmonary Tuberculosis
7. Severe Jaundice
8. Pregnancy
9. Malignancy
Any other severe systemic disease
779
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF SINGLE /COMPOUND /HERBO /
HERBOMINERAL COMPOUND DRUGS IN THE MANAGEMENT OF
KALA-AZAR
CASE REPORT FORM II – HISTORY
4. Centre…………………………
780
14. Income per capita per month in rupees: ____________________
15. Religion: Hindu 1 Muslim 2 Sikh 3
Christian 4 Parsi 5
16. Marital status Married 1 Unmarried 2 Widow 3
Divorced 4 Widower 5
17. Result: Good Response 1 Fair Response 2
Poor Response 3 No Response 4
Drop out 5 LAMA 6
Death 7
22. Diarrhoea
781
Spell out the medicine given and results obtained: _______________________________
37. Hypertension
41. Cancer
782
43. Tuberculosis
Personal History
Sama
Sama
Physical Examination
52. Built: Lean Medium Heavy
53. Gait Normal Abnormal
783
59. Respiration per min. ___________________________
Yes No
60. Pallor
61. Jaundice
62. Emaciation
Present Absent
63. Lymphadenopathy
If present indicate group …………………..................................……………………….
Systemic Examination
Abdomen
67. Shape: Normal Abnormal
68. Distention : Present Absent
If present indicate ……................................…………………………………………..
69. Distended veins: Present Absent
70. Umbilicus: Normal Abnormal
If Abnormal specify ……….................................................……………………………….
71. Tenderness : Yes No
If yes specify ………………………...................................…………………………….
72. Rigidity: Present Absent
784
If present then specify ……………….......................................................……………
73. Spleen: Mild Moderate Massive
enlargement
74. Spleen-consistency Soft Hard Firm
785
88. Dushya Involved: Rasa Rakta Mamas Meda
Aruchi (Anorexia)
Avipaka (Indigestion)
Chhardi (Vomiting)
786
Yes No
93. Pureeshavaha Srotas
Alpa alpa purisha (Not clear, repeated, scanty defecation)
Sashoola Purisha (Painful defection)
Atidrava pureesha (Diarrhea)
Atigrathita pureesha (Scybala)
94. Mutravaha Srotas
Bahumatrata (Polyurea)
Yes No
787
Arasajnata (Testelessness)
Hrillasa (Nausea)
Gaurava (Feeling heaviness)
Tandra (Drowsiness)
Angamarda (Body cramps)
Jvara (Fever)
Pandu (Anaemia)
Avasada (Lassitude)
Klaivya (Sexual inadequacy)
Karshya (Emaciation)
Agnimandya (Diminished appetite)
97. Rakta Vaha Srotas
Pidika (Boils)
Raktapitta (Bleeding from any of the orifice)
Mukhapaka (Stomatitis)
Vidradhi (Absess)
Charma Roga (Skin disease)
Kamala (Jaundice)
Yes No
98. Mamsa Vaha Srotas
Arbuda (Tumor)
Alajee (conjunctivitis)
Upajivihika (Epiglotitis)
788
99. Medovaha Srotas
Tandra (Drowsiness)
Alasya (lethargy)
Dantashoola (Toothache)
Bhrama (Vertigo/Giddiness)
Murchha (Syncope)
Mithyagyana (Illusion)
Garbhapata (Abortion)
789
Santana Vikriti (Congenital deformity of the children)
Anartava (Amenorrhoea)
Vandhyatva (Sterility)
790
COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF SINGLE / COMPOUND / HERBOMINERAL
COMPOUND DRUGS IN THE MANAGEMENT OF KALA-A-ZAR
CASE REPORT FORM III -CLINICAL AND PHYSIOLOGICAL ASSESSMENT
(2, 4, 6 & 8 weeks)
4. Centre…………………………
1. Clinical Parameter
a) Subjective symptoms
1. Fever
2. Loose motion
3. Pain abdomen
4. Weakness
5. Bleeding
791
b) Objective signs
1. Temperature
2. Pallor
3. Anemia
4. Emaciation (Body wt.)
5. Pulse rate
6. Lymphadenopathy
7. Increased pigmentation of the skin
8. Enlargement of spleen
9. Enlargement of liver
10. Measurement of girth of abdomen.
792
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF SINGLE / COMPOUND / HERBOMINERAL
COMPOUND DRUGS IN THE MANAGEMENT OF KALA-A-ZAR
CASE REPORT FORM III A - ADVERSE EVENTS RECORD
(2, 4, 6 & 8 weeks)
1. Name of the Subject: ………………………………………….......................……....…
2. Address ……………………………………………………………..............…………..
4. Centre…………………………
ADVERSE EVENTS
1. Does the patient have any symptoms with medication in trial group? Yes No
Please complete all sections & enter l approximate information in numbers in open boxes
1 2 3 4
Adverse
Experience
793
Date started
Date
Time
Date stopped
Pattern
Isolated-1
Intermittent-2
Continuous-3
Severity
Mild-1
Moderate-2
Severe-3
Serious*
Yes-1
No-2
794
Relationship
to study
medication
Unrelated-1
Possible-2
Probable-3
Unrelated: A reaction that does not follow a reasonable temporal sequence from the
administration of the drug; or a known adverse reaction pattern of the suspected drugs could
have been produced by the patients clinical stage, intermittent illness, trauma, accidents etc:
Possible: follows a reasonable temporal sequence from administration of the drug; follows a
known response pattern to the suspected drug but could have been produced by the patients
clinical stage or other modes of therapy administered to the patients;
Probable: follows a reasonable temporal sequence from administration of the drug; follows a
known response pattern to the suspected drug; that could not be reasonably explained by the
known characteristics of the patient's clinical state.
795
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF SINGLE / COMPOUND / HERBOMINERAL
COMPOUND DRUGS IN THE MANAGEMENT OF KALA-AZAR
CASE REPORT FORM IV – LABORATORY INVESTIGATIONS
1. Name of the Subject: …………………………………………........……………………
2. Address …………………………………………………………….......……………….
4. Centre…………………………
1 2 3 4
Urine
10. Sugar: ……………………....……
11. Albumin: …………………………
12. Pus cell: …………………………
13. Cast: ……………………….........
14. RBC: ………………………....…
15. Bile salt: …………………….…..
16. Bile pigment: …………………....
796
Stool
17. Ova: ……………………..............….......…
18. Cyst: ……………….................……........…
19. Occult blood: ………………………….......
20. Stercobiline: ………………………...….......
21. Sputum A.F.B: ………………………….....
HAEMATOLOGICAL INVESTIGATION
Blood
22. Hb.% : …………………….........................
23. T.L.C.(In thousands) : ……………………..
24. D.L.C.: P (%): ______ L (%) ______ B (%) _______ M (%) _______ E (%) _______
25. E.S.R.: ………………….............................
26. P.C.V.: ………………………......................
27. M.C.V.: ………………………....................
28. Platelate count: …………………….........…
29. Reticulo Cyte: …………..……....................
Count: ………………………......................
(In thousands)
30. B.T.: …………………….........................…
31. C.T.: ………………………….....................
32. P.T.: ………………………......................…
33. T. Protein: ………………………................
34. A/G ratio: ……………………….............…
35. F.B.S.: …………………………..................
36. P.P.B.S.: ………………...............…………
37. S. Bilirubin: …………………..........………
797
38. S. Alkaline Phosphatase: ……………..……
39. S.G.O.T.: ………………………..............…
40. S.G.P.T.: ………………………...............…
RADIOLOGICAL INVESTIGATION
42. X-Ray Normal Abnormal
Chest
a) Bone marrow
b) Spleen
c) Liver
d) Lymph gland
a) Bone marrow
b) Spleen
c) Liver
d) Lymph gland
798
ASSESSMENT OF THE EFFICACY OF CERTAIN
HERABL / HERBO-MINERAL DRUGS IN THE
MANAGEMENT OF SLEEPADA (FILARIASIS)
799
Blank
800
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF THE EFFICACY OF CERTAIN AYURVEDIC / HERBO-
MINERAL DRUGS IN THE MANAGEMENT OF SLEEPADA
(FILARIASIS)
I. BACKGROUND
The control of the disease is dependent on the control of mosquito breeding and
elimination of the intermediate host Culexfatigans. It is a global problem. References of this is
found in Ayuervedic text book where in it has been described as a swelling of legs and feet due
to vitiation of Mamsa & Rakta by Kapha Dosha. The detailed description of the disease, covering
clinical features, etio-pathogenesis, the different types, the prognosis and the epidemiological details
of the disease have been provided. The treatment of this disease is Siravedh and Kaphanashak
remedies as described in Charak Samhita.
The characteristic features of the disease are the onset of painful swelling in groins with
fever which gradually descends down to leg & foot. The other parts of the body may be affected
through scrotum in male and breast in female. It is further stated that though the disease may be
due to the involvement of all three doshas, but the predominance of Kapha is obvious in all the
three varities.
This disease is a result of the infestation of filarial parasite, Wuchereria bancrofti. The
frequency of this disease is very much related to the situation where mosquito breeding is more
prevalent. The mosquito Culex fatigans is of crucial importance in the life cycle of filarial parasite.
Ayurveda has also recognized this disease from very earliest time and its description and
therapy have been developed in this system. In Ayurvedic literatures so many herbal &
herbomineral drugs are mentioned viz. Guduchi, Punarnava, Saptaparna, Sharapunkha, Rohitaka
etc., as herbal preparation & Nityodit Rasa, Slipadari Rasa, Kanchnara Guggulu, Gokshuradi
Guggulu etc. as compound herbomineral formulations for the treatment of Sleepada.
References
1. Pandit.Kasinath Sashtri and Dr. Gorakhanath Chaturvedi (1984) Charaka Samhita, (text with
Hindi commentary) XIIth Edition (1984), Published by Chaukabha Vidhya Bhavan, Varanasi,
India.
2. Ambika Dutta Sashtri(1989) Susruta Samhita (text with Hindi commentary) VIIth Edition
Chaukhamba Sanskrit Series Office, Varanasi.
3 Shri Pandit Lal Chandra vaidya (1963), Astanga Hridya ((text with Hindi commentary), Moti Lal
Banarsi Das Publication, Varanasi
4. Harisson’s Principles of internal medicine, Volume-1, 14th Edition, International Editions, 1998,
Published by McGraw-Hill CompaniesInc.
801
(filaria). The objective of this study are the assessment of some certain herbal / herbo-mineral
compound preparation in the management of Sleepada (filaria) and to assess the importance of
herbal drugs for the management of the challenging problem ‘Sleepada’
II. OBJECTIVE
To assess the efficacy of certain Herbal / Herbo-mineral drugs in the management of
Sleepada (Filariasis)
III. CENTRE
CCRAS identified centers
IV. SAMPLE SIZE AND METHOD
Sample size — 200 (100 patients in each group)
Treatment — Herbal / Herbo-mineral drugs
Design of the study — Single blind
Period of Study — 1 month
V. CRITERIA FOR INCLUSION
1. Age – 10 to 60 years.
2. Sex – both male & female
3. Positive case of Filaria
4. Patients having clinical features like Lymphadenities, Lymphangitis, Lymphodema, deformity,
chylurea & fever will be selected irrespective of positive blood smear of microfilaria.
VI. CRITERIA FOR EXCLUSION
1. Age below 10 yrs & above 60 yrs.
2. Patients having nodular deformity, wound, ulcer, thorny deformity, anthill like deformity,
nutritional odema, odema due to renal problems, cardiac disorder & arthritis disorders.
3. Any other serious systemic disease like – Pulmonary tuberculosis, Jaundice, HIV positive
cases / Malignancy.
4. Pregnancy & Lactating mother.
802
VII. CRITERIA FOR WITHDRAWL
During the course of the trial treatment, if any serious conditions or any serious adverse
events which requires urgent treatment or if patient himself want to withdrawn from the trial and
managed by the principal investigators accordingly.
VIII. ROUTINE EXAMINATION & ASSESSMENT:-
A detailed clinical history and physical examination of each patients will be recorded as
per proforma (from I & IA). The Clinical, Pathological, Biochemical & other Lab investigation will
be done before treatment, during treatment and at the end of treatment will be carried out as per
recorded in the proforma. The assessment of the result will be done on the basis of disappearance
of M.F. and improvement in the clinical features.
IX. STATISTICAL ANALYSIS
Data collected will be analyzed using appropriate statistical tools.
X. CRITERIA FOR ASSESSMENT OF THERAPY
Response Assessment Criteria
1. Good Response — 75 % & above relief in symptoms
2. Fair Response — 50 % & 74% above relief in symptoms
3. Poor Response — 25% , 49% & 25% above relief in symptoms.
4. No Response — No relief in symptoms or other wise withdrawn
from the study.
XI. TRIAL MONITORING AND DATA ANALYSIS
The monitoring of progress of the trial & data analysis will be undertaken by CCRAS,
New Delhi.
XII. ETHICAL REVIEW
1. Ethical Committee (IEC): The proposal will be placed before Ethical Committee (IEC)
of trial center for getting clearance certificate before the project is initiated. Patient’s
information sheet and informed consent form will be submitted along with project proposal
for approval by EC. Both will be maintained in duplicate with one copy given to the
patient at the time of entry to the trial.
2. Data and Safety Monitoring Board: A Data and safety monitoring board (DSMB) at
Hqrs will carefully monitor the data and side effects during the period of study and put in
803
a place where by prompt reporting of adverse events occur. The data will be reviewed as
every 20 participants entered the study and administered the trial drugs. The research
team will report immediately to the PI and Data Monitoring Board 1) any life threatening
conditions whether they are perceived to be study related or not. The Board decides
whether the adverse effects warrant discontinuation of the study protocol. Protocols will be
written and approved for the treatment of study related adverse events
XIII. TRAVELING EXPENSES FOR RESEARCH SUBJECTS
A consolidated amount of Rs…../- per visit i.e., on the 1st day of recruitment after
screening, 15th, 30th, 45th, 60th, 75th and 90th days (7 times).
XIV. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
Short-term two-day training will be provided to the Investigators and Laboratory
personnel involved in the multi-centric trial at CCRAS Hqrs. and Central Research Institute
(Ay.), New Delhi. The investigators and technicians will be detailed about the clinical trial
conduct and laboratory procedures in order to maintain the uniformity.
XV. LABORATORY INVESTIGATIONS
The Laboratory Investigations (Pathological/Biochemical, etc.), which are not available at
research Institutes should be conducted at identified reputed labs /Government Institutes
under intimation to this Council following codal formalities.
804
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF THE EFFICACY OF CERTAIN HERBAL / HERBO-
MINERAL DRUGS IN THE MANAGEMENT OF SLEEPADA (FILARIASIS)
WRITTEN INFORMED CONSENT FORM
CERTIFICATE BY INVESTIGATOR
I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: ……………… Signature of the subject: …………..........………………
Name …………………………………….........………..
CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending physician, the purpose of the
clinical trial and the nature of drug treatment and follow-up, including the laboratory investigations
to be performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so.
I, exercising my free power of choice, hereby give my consent to be included as a subject
in the clinical trial on “Assessment of Safety & Therapeutic Efficacy of Certain Ayuervedic /
Herbal / Herbomineral drugs in the management of Sleepada (Filariasis).”
805
ENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF SAFETY & THERAPEUTIC EFFICACY OF CERTAIN
AYUERVEDIC / HERBOMINERAL DRUGS IN THE MANAGEMENT OF
SLEEPADA (FILERIASIS)
PATIENT INFORMATION SHEET
What is the study about?
The available treatment for Sleepada (Filariasis) in modern medical science like drugs
Hetrazan, Banocide forte etc. have made tremendous success in providing instant or symptomatic
relief but there is recurrent acute exacerbation and remission. In Ayuerveda, many drugs seem to
possess a anti Filarial effect of which certain Ayuervedic / Herbal / Herbomineral drugs that have
been in practice as well as have shown anti Filarial effect have been taken up for the study.
What will you have to do?
Your doctor will explain clearly what you have to do. It is important that you follow the
instructions scrupulously. The study will take approximately 3 months to complete. During this
period, you are expected to visit the hospital 6 times for clinical and physiological assessment.
Before you start treatment, during the first visit to the clinic you will undergo a complete
physical examination, ECG and X-ray, Blood, MF test and urine samples will also be taken. This
is to make sure that you are eligible for the study.
If you are found eligible, you will be supplied with sufficient quantities of drugs to last until
your next visit. If any adverse reactions like skin allergy, nausea, vomiting and palpitation/tremor
etc., noticed during the treatment period, this should be noticed to the Principle Investigator.
Advice: (To be given along with Patients Information Sheet)
806
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF SAFETY & THERAPEUTIC EFFICACY OF CERTAIN
HERBAL / HERBOMINERAL DRUGS IN THE MANAGEMENT OF
SLEEPADA (FILERIASIS)
CASE REPORT FORM I – SCREENING
(Enter a √ in the appropriate box)
1. Centre: ………………..……….........
7. Date of admission:
8. Date of discharge:
1. Age – 10 to 60 years.
5. Lymphangitis
6. Lymphodema
7. Deformity
8. Chylurea
9. Fever
807
CRITERIA FOR EXCLUSION Yes (1) No (0)
12. Wound
20. Jaundice
808
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF SAFETY & THERAPEUTIC EFFICACY OF CERTAIN
HERBAL / HERBOMINERAL DRUGS IN THE MANAGEMENT OF SLEEPADA
(FILERIASIS)
CASE REPORT FORM II – HISTORY
(Enter a √ in the appropriate box)
1. Centre: …………….........…........….
7. Date of admission:
8. Date of discharge:
809
14. Lymphangitis
16. Deformity
17. Chylurea
18. Fever
19. Rigor
Unani Homoeopathy
810
27. Past illness, having relation with present illness: Yes No
32. Cancer
34. Tuberculosis
Personal History :
35. Diet: Veg Non-veg Lacto-ova-veg
36. Sleep Good Disturbed Insomnia
Sannipataja
Sama
811
42. Tobacco chewing
49.
[
B.M.I Weight (kg.)
Height (meters) 2 ] ____________
812
58. Anaemia
59. Jaundice
60. Pigmentation
62. Deformities
63. Lymphadenopathy
Systemic Examination
Normal Abnormal
66 C.V.S. (with chest)
813
Samprapti (Pathogenesis) of the disease according to Ayurvedic concept
Shukra Ojas
Shukra Ojas
Bheda
Srotas Pareeksha
71. Prana vaha srota
Alpa Alpa Swasa (Shortened Breathing) 1
Atisrama Swasa (Increased respiration rate) 2
Abhikshna Swasa (Chyne stroke breathing) 3
Kupita Swasa (Vitiated breathing) 4
Sashula swasa (Dyspnoea with pain) 5
72. Udakavaha srota
Jihva sosha (Dryness of tongue) 1
Oustha sosha (Dryness of lip) 2
Talu sosha (Dryness of palate) 3
814
Kantha sosha (Dryness of throat) 4
Kloma sosha (Excessive thirst) 5
Trishna (Thirst) 6
73. Annavaha srotas
Anannabhilasha (Lack of desire for food) 1
Aruchi (Anorexia) 2
Avipaka (Indigestion) 3
Chhardi (Vomitting) 4
74. Rasa Vaha srotas
Mukha vairsya (Bad taste in mouth) 1
Arasajnata (Tastelessness) 2
Hrillasa (Water brash) 3
Gaurava (Feeling of heaviness) 4
Tandra (Stupor) 5
Anga marda (Body ache) 6
Jwara (Fever) 7
Pandu (Anaemia) 8
Avasada (Depression) 9
Klaibya (Loss of libibo) 10
Karshya (Emaciation) 11
Agnimandya (Diminished appetite) 12
75. Rakta vaha srotas
Pidika (Boils) 1
Rakta Pitta (Bleeding from any of the orifice) 2
Mukha Paka (Stomatitis) 3
Vidradhi (Abscess) 4
815
Charma roga (Skin disease) 5
Kamala (Jaundice) 6
76. Mamsavaha srotas
Arubuda (Tumour) 1
Alajee (Phlyctenular conjunctivitis) 2
Gandamalaa (cervical lymphadenitis) 3
Upji (Epiglotis) 4
Adhimamsa (Protruberance of flesh/cancer/cyst) 5
Putimamsa (decayed flesh/gangrene) 6
77. Medo vaha srotas
Maladhikya (Excess of excreta) 1
Hastapada daha (Burning sensation in the palm and sole) 2
Hastapada suptata (Numbness of the palm and sole) 3
Tandra (Stupor) 4
Dehachikkanta (Greasiness of the skin) 5
Alasya (Lethargy) 6
78. Asthivaha srotas
Adhyasthi (Hypertrophy of bone) 1
Adhidanta (Redundant tooth) 2
Dantashoola (Toothache) 3
Asthi shoola (Bone pain) 4
Kesha, loma, nakha, samshru vikara 5
(Any defects of hair, hair follicles, nails and mustaches)
79. Majja vaha srotas
Parva shoola (Pain in the Interphalangeal joints) 1
Bhrama (Vertigo/Giddiness) 2
816
Moorchh (Syncope) 3
Mithyajnana (Illusion) 4
80. Shukra vaha srotas
Klaivya (Sterility / impotence) 1
Aharshan (Loss of erection) 2
Garbha pata (Abortion) 3
Santana Vikriti (Congenital deformity of the children) 4
81. Manovaha srotas
Manovibramsha 1
Budhivibramsha 2
Sanjna Vibhramsha 3
Smritivibhramsha 4
Bhaktivibhramsha 5
Sheelavibhramsha 6
Chesta Vibhramsha 7
Acharavibhramsha 8
82. Artava vaha srotas
Anartava (Amenorrhoea) 1
Vandhyatva (Sterility) 2
83. Mutra vaha srotas
Bahumutra (Polyuria) 1
Atibadhata (Urination with obstruction) 2
Prakop-mutra (Defective Urination / Difficulty 3
in micturition)
Alpaalpa (Scanty urination) 4
Aabhikshna (Constant / repeated urination) 5
817
Bahulamutrata (Urine with prostatic secretion) 6
Sashoola amutrata (Painful micturition) 7
84. Pureeshavaha srotas
Alpaalpa Pureesha (Scanty defecation) 1
Sashoola Pureesha (Painful defecation) 2
Atidrava Pureesha (Diarrhoea) 3
Atigrathita Pureesha (Scybala) 4
85. Sweda vaha srotas
Aswedana (Loss of perspiration) 1
Atiswedana (Profuse sweating) 2
Parushya (Roughness of the skin) 3
Lomaharsha (Thrill) 4
Angaparidaha (Burning sensation in the body) 5
Dose
Vehicle
Diet
818
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF SAFETY & THERAPEUTIC EFFICACY OF CERTAIN
HERBAL / HERBOMINERAL DRUGS IN THE MANAGEMENT OF
SLEEPADA (FILERIASIS)
CASE REPORT FORM – III CLINICAL ASSESMENT
1. Centre: ……………….……….
7. Date of admission:
8. Date of discharge:
819
(iii)
(iv)
c). Lymphoedema
(i)
(ii)
(iii)
(iv)
d). Deformity (Score with measurement in cms.)
(i)
(ii)
(iii)
(iv)
(v)
(vi)
e). Pain
(i)
(ii)
(iii)
(iv)
f). Tenderness
(i)
(ii)
(iii)
(iv)
g). Fever
(i)
820
(ii)
(iii)
(iv)
h). Rigor
(i)
(ii)
(iii)
(iv)
2. Laboratory Investigation
i) Microfilaria
ii) Chyle
iii) M.F. Count per 20 Cu.mm
In night blood/ DECP Test
iv) Immunoglobulins
821
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF SAFETY & THERAPEUTIC EFFICACY OF CERTAIN
HERBAL / HERBOMINERAL DRUGS IN THE MANAGEMENT OF
SLEEPADA (FILERIASIS)
CASE REPORT FORM III A - ADVERSE EVENTS RECORD
(0, 15, 30, 45, 60, 75, 90 days)
1. Centre: ………………............…….
7. Date of admission:
8. Date of discharge:
ADVERSE EVENTS
1. Does the patient have any symptoms with medication in trial group? Yes No
Please complete all sections & enter l approximate information in numbers in open boxes
1 2 3 4
Adverse
Experience
822
Date started
Date
Time
Date stopped
Pattern
Isolated-1
Intermittent-2
Continuous-3
Severity
Mild-1
Moderate-2
Severe-3
*Mild-No interference with usual activity. *Moderate-Significant interference with usual
activities. *Severe-Prevents usual activities.
Serious*
Yes-1
No-2
Serious ADE is defined as fatal, life-threatening, permanently, disabling requires inpatient
hospitalization or as a congenital anomaly, cancer or overdose. If yes, please till serious
Adverse experiences report form provided. In case of Serious adverse event sponsor should
be informed immediately telephonically.
823
Relationship
to study
medication
Unrelated-1
Possible-2
Probable-3
Unrelated: A reaction that does not follow a reasonable temporal sequence from the
administration of the drug; or a known adverse reaction pattern of the suspected drugs could
have been produced by the patients clinical stage, intermittent illness, trauma, accidents etc:
Possible: follows a reasonable temporal sequence from administration of the drug; follows a
known response pattern to the suspected drug but could have been produced by the patients
clinical stage or other modes of therapy administered to the patients;
Probable: follows a reasonable temporal sequence from administration of the drug; follows a
known response pattern to the suspected drug; that could not be reasonably explained by the
known characteristics of the patients clinical state.
824
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF SAFETY & THERAPEUTIC EFFICACY OF CERTAIN
HERBAL / HERBOMINERAL DRUGS IN THE MANAGEMENT OF
SLEEPADA (FILERIASIS)
CASE REPORT FORM IV – LABORATORY INVESTIGATIONS
1. Centre: ………………..........……….
825
Lymphocyte : …………………………
Eosinophil : …………………………
Basophil : …………………………
Monocyte : …………………………
vi) E.S.R.
vii) Immunoglobulin
826
HAEMATOLOGICAL DISORDERS
SECTION - XIV
827
Blank
828
MULTICENTRIC OPEN CLINICAL TRIAL OF
SELECTED DRUGS IN IRON DEFICIENCY ANAEMIA
830
MULTICENTRIC OPEN CLINICAL TRIAL OF SELECTED DRUGS IN IRON
DEFICIENCY ANAEMIA
I. BACKGROUND
Iron Deficiency Anaemia1 (which is described under the disease Panduroga in Ayurveda)
is a worldwide problem with the highest prevalence in developing countries. It is found especially
among women of childbearing age, young children and during pregnancy & lactation. Detailed
description concerning the etiology, pathogenesis classification and management of Anaemia
(Panduroga) is available in classical literatures of Ayurveda.
Iron Deficiency is the most common cause of nutritional Anaemia; others are foliate &
Vitamin B-12 deficiency. Iron deficiency can arise either due to inadequate intake or poor
bioavailability of dietary iron or due to excessive loss of iron from the body. The poor
bioavailability is considered to be major reason for widespread iron deficiency. Women lose a
considerable amount of iron in menstruation. Some of other factors leading to anaemia are
intestinal parasites (hookworm etc.) & malaria.
Current Medical therapy –Prospects
In conventional medicine, various forms of iron viz. Ferrous sulfate, ferrous fumerate etc.
are commonly prescribed, but these therapies have their noted adverse effects e.g. nausea,
vomiting, abdominal pain, diarrhoea /constipation.
Owing to the gravity of the situation, need is felt for search of safe /effective Ayurvedic
oral dosage forms to improve the haemoglobin level in iron deficiency Anaemia. Keeping the
gravity of the situation and the public health needs in view, the council has initiated scientific
studies on Dhatri Lauha, a promising formulation that is being successfully prescribed by
Ayurvedic physicians without any side effects since centuries. The formulation has been
standardized after formulating SOPs besides safety / toxicity evaluation.
The formulation is found safe and biological activity studies revealed significant haematenic
effect. (Unpublished data of CCRAS) The objective of current study is to assess clinical safety
and efficacy through measurable objective parameters.
Reference:
1. Charaka, 1962, Charaka Samhita, Chikitsa Sthana Chapter– 16, Choukhamba Sanskrit Series, Varanasi
2. A textbook of Preventive and Social Medicine, PARK 15th Edition, 403-404.
3. John W. Adamson, Harrison’s Principles of Int. Medicine, P.660-665.
4. B.C. Mehta, API Text Book of Medicine, 5th Edition reprint, 983-984.
5. Harrisson’s Principles of Internal Medicine, Volume 1,15th Edition.
831
II. OBJECTIVES
1) Observe the effect of Dhatri lauha on haematological parameters viz. Hb%, MCV,
MCHC, TIBC, Serum iron content and Serum ferritin in Iron Deficiency Anaemia
subjects.
2) Observe the clinical safety of Dhatri lauha in Iron Deficiency Anaemia subjects.
III. CENTRE
CCRAS identified Institutes.
832
VI. CRITERIA FOR EXCLUSION
1. Age less than 15 years and more than 60 years.
2. Pregnancy and lactation
3. Severe Renal / Hepatic/ Cardiac disease
4. Any continuing blood loss e.g. Haematemesis, Melaena, bleeding piles etc.
5. Dimorphic anaemia
X. STATISTICAL ANALYSIS
Data on clinical symptoms and objective tests before and after the treatment will be
tabulated and analyzed using appropriate statistical tools. However the data of each case will have
to be communicated on completion of trial therapy to the Statistical Officer of CCRAS through e-
mail (ccras_stat@nic.in).
833
XII. ETHICAL REVIEW:
A. Institutional Ethical Committee (IEC): The proposal will be placed before Institutional
Ethical Committee (IEC) of trial center for getting clearance certificate before the project is
initiated. Patient’s information sheet and informed consent form will be submitted along with
project proposal for approval by IEC.
B. Data and safety monitoring board: A Data and safety monitoring board (DSMB) at
Hqrs will carefully monitor the data and side effects during the period of study and put in a place
where by prompt reporting of adverse events occur and take appropriate steps in case of any
adverse events occur. The data will be reviewed for every 20 participants included into the study
and administered the trial drugs. The research team will report immediately to the PI and Data
Monitoring Board if any life threatening conditions whether they are perceived to be study related
or not. The Board decides whether the adverse effects warrant discontinuation of the study
protocol. Protocols will be written and approved for the treatment of study related adverse events.
834
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
WRITTEN INFORMED CONSENT FORM
CERTIFICATE BY INVESTIGATOR
I certify that I have disclosed all details about the study in the terms easily understood by
the subject.
Date: ___________ Signature of the investigator: _______________________
Name ________________________________________
CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending physician about the purpose of
the clinical trial and the nature of drug treatment and follow-up, including the laboratory
investigations to be performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so. I am willing to undergo any risk for inclusion in
this study.
I, exercising my free power of choice, hereby give my consent to be included as a subject
in the clinical trial on “Multicentric Open Clinical Trial of Selected (Dhatri Lauha) Drugs in
Iron Deficiency Anaemia.”
835
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC OPEN CLINICAL TRIAL OF SELECTED DRUGS IN IRON
DEFICIENCY ANAEMIA
PATIENT INFORMATION SHEET
If you are found eligible, you would be put on trial treatment for 45 days.
At each visit, you will be supplied with sufficient quantities of drugs to last until your next
visit. If any adverse reactions like skin allergy, nausea, vomiting and palpitation/tremor etc., noticed
during the treatment period, this should be noticed to the Principle Investigator.
836
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC OPEN CLINICAL TRIAL OF SELECTED DRUGS IN IRON
DEFICIENCY ANAEMIA
CASE REPORT FORM I – SCREENING
BEFORE TREATMENT
(Enter a √ in the appropriate box)
3. Subject Name__________________________________
4. Sex Male Female
6. Address: Permanent postal address with phone number & E-mail if any.
_____________________________________________________________________
_____________________________________________________________________
4. S. Ferritin < 30 ìg /L
6. MCV<80 fl
837
11. Severe Renal/Hepatic/Cardiac disease*
12. Any continuing blood loss e.g. hematemesis,
melena and bleeding piles etc.
13. Dimorphic anaemia
14. History of Chronic Infections
838
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC OPEN CLINICAL TRIAL OF SELECTED DRUGS IN IRON
DEFICIENCY ANAEMIA
CASE REPOTR FORM II – HISTORY
(Enter a √ in the appropriate box)
2. Center: ____________________
7. Address: Permanent postal address with phone number & E-mail if any.
__________________________________________________
__________________________________________________
8. Educational status: Illiterate 1 Read and Write 2
Primary School 3 Middle School 4
High School 5 College 6
Other (specify) 7 I.N.A. 8
839
HISTORY OF PRESENT ILLNESS:
Chief complaints with duration (in days)
Yes (1) No (0) If Yes Duration (in days)
12. Weakness
13. Fatigue
14. Palpitation
16. Breathlessness
18. Asymptomatic
PERSONAL HISTORY:
Addictions: Yes (1) No (0)
22. Alcohol:
24. Tobacco
840
27. Sharirik Prakriti: Vata 1 Pitta 2 Kapha 3
Vata-Kaphaj 4 Vata-Pittaja 5 Pittaja-Kaphaja 6
Sannipataja 7
PHYSICAL EXAMINATION:
28. Built Lean 1 Medium 2 Heavy 3
29. Gait Normal 1 Abnormal 2
30. Body weight (Kg.) __________
31. Height (cm.)_________
32. Body temperature (oF)____________
33. Blood pressure (in sitting posture of right upper limb) –
Systolic_______mm/Hg
Diastolic _______mm/Hg
34. Pulse rate__________/min. (Radial pulse of right upper limb)
35. Respiration rate _________/min.
Present (1) Absent (0)
36. Pallor
37. Koilonychia
38. Lymphadenopathy
SYSTEMIC EXAMINATION:
Normal (0) Abnormal (1)
40. CNS
841
If abnormal, specify abnormalities________________________________
Liver
Spleen
SAMPRAPTI (PATHOGENESIS)
842
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC OPEN CLINICAL TRIAL OF SELECTED DRUGS IN IRON
DEFICIENCY ANAEMIA
CASE REPORT FORM – III PERIODICAL OBSERVATION AND CLINICAL
ASSESSMENT
(0th day)
(Enter a √ in the appropriate box)
2. Center: _______________________
7. Date of Assessment:
8. Weakness
9. Fatigue
10. Palpitation
12. Breathlessness
14. Asymptomatic
843
If yes, specify: ___________________________
___________________________
___________________________
844
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC OPEN CLINICAL TRIAL OF SELECTED DRUGS IN IRON
DEFICIENCY ANAEMIA
CASE REPORT FORM – III PERIODICAL OBSERVATION AND CLINICAL
ASSESSMENT
(On 15th Day)
(Enter a √ in the appropriate box)
7. Date of Assessment:
10. Palpitation
12. Breathlessness
14. Asymptomatic
845
Adverse Reactions: Present (1) Absent (0) If yes, Duration (in days)
17. Nausea
18. Diarrhoea
846
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC OPEN CLINICAL TRIAL OF SELECTED DRUGS IN IRON
DEFICIENCY ANAEMIA
CASE REPORT FORM – III PERIODICAL OBSERVATION AND CLINICAL
ASSESSMENT
(On 30th Day)
(Enter a √ in the appropriate box)
2. Center: _______________________
7. Date of Assessment:
8. Weakness
9. Fatigue
10. Palpitation
12. Breathlessness
14. Asymptomatic
847
Adverse Reactions: Present (1) Absent (0) If yes, Duration (in days)
16. Burning sensation in abdomen
17. Nausea
18. Diarrhoea
848
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC OPEN CLINICAL TRIAL OF SELECTED DRUGS IN IRON
DEFICIENCY ANAEMIA
CASE REPORT FORM – III PERIODICAL OBSERVATION AND CLINICAL
ASSESSMENT
(On 45th Day)
(Enter a √ in the appropriate box)
9. Fatigue
10. Palpitation
12. Breathlessness
14. Asymptomatic
849
Adverse Reactions: Present (1) Absent (0) If yes, Duration (in days)
17. Nausea
18. Diarrhoea
850
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC OPEN CLINICAL TRIAL OF SELECTED DRUGS IN IRON
DEFICIENCY ANAEMIA
CASE REPORT FORM IV-A – LABORATORY INVESTIGATIONS
(0th Day)
(Enter a √ in the appropriate box)
7. Date of Assessment:
URINE EXAMINATION
Routine
Absent (0) Present (1)
8. Sugar
9. Albumin
Microscopic
Absent (0) Present (1)
12. RBC
851
STOOL EXAMINATION
Routine
Absent (0) Present (1)
Microscopic
Absent (0) Present (1)
17. Ova/Cyst
BLOOD
18. TC (Cells/Cu. mm.) _______________
19. DC: P ______ (%) L ______ (%) E ______ (%) M ______ (%) B ______ (%)
20. ESR (mm / 1st hour.) _________________
21. M.C.H.C. (g/dl)______________________
22. M.C.V. (fl)__________________________
23. Serum iron (ìg/dl)_____________________
24. Serum ferritin (ìg/L) ___________________
25. Hb (g/dl) (Cyanomethamoglobin method) _____________________________________
26. PCV (%) _________________
27. TIBC (μg/dl) ____________
28. General Blood Picture for morphology of RBC ______________________________
852
30. SGPT (IU/L) ________
31. SGOT (IU/L) ________
32. S. Alkaline phosphatase (U/L) ________
33. S. Proteins (Total) (g/dl) _____________
34. Albumin (g/dl) ________
35. Globulin (g/dl) ________
Renal function tests
36. Blood urea (mg/dl) __________
37. S. Creatinine (mg/dl) _________
853
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC OPEN CLINICAL TRIAL OF SELECTED DRUGS IN
IRON DEFICIENCY ANAEMIA.
CASE REPORT FORM IV-B – LABORATORY INVESTIGATIONS
(15th Day)
(Enter a √ in the appropriate box)
7. Date of Assessment:
8. M.C.H.C. (g/dl)____________________
9. M.C.V. (fl)________________________
10. Serum iron (ìg/dl)___________________
11. Serum ferritin (ìg/L) _________________
12. Hb (g/dl) (Cyanomethamoglobin method) _______
13. PCV (%) _______________
14. TIBC (ìg/dl) ___________
15. General Blood Picture for morphology of RBC ____________________
Normocytic Normochromic (1) Normocytic Hypochromic (2)
854
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC OPEN CLINICAL TRIAL OF SELECTED DRUGS IN
IRON DEFICIENCY ANAEMIA.
CASE REPORT FORM IV-B – LABORATORY INVESTIGATIONS
(30th Day)
(Enter a √ in the appropriate box)
2. Center: _______________________
7. Date of Assessment:
8. M.C.H.C. (g/dl)____________________
9. M.C.V. (fl)________________________
10. Serum iron (ìg/dl)___________________
11. Serum ferritin (ìg/L) _________________
12. Hb (g/dl) (Cyanomethamoglobin method) _______
13. PCV (%) _______________
14. TIBC (ìg/dl) ___________
15. General Blood Picture for morphology of RBC ____________________
855
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC OPEN CLINICAL TRIAL OF SELECTED DRUGS IN IRON
DEFICIENCY ANAEMIA
CASE REPORT FORM IV-A – LABORATORY INVESTIGATIONS
(45th Day)
(Enter a √ in the appropriate box)
2. Center: ____________________
7. Date of Assessment:
URINE EXAMINATION
Routine
Absent (0) Present (1)
8. Sugar
9. Albumin
Microscopic
Absent (0) Present (1)
12. RBC
856
STOOL EXAMINATION
Routine Absent (0) Present (1)
Microscopic
Absent (0) Present (1)
17. Ova/Cyst
BLOOD
18. TC (Cells/Cu. mm.) _______________
19. DC: P _____ (%) L _____ (%) E _____ (%) M _____ (%) B _____ (%)
20. ESR (mm / 1st hour.) __________
21. M.C.H.C. (g/dl)________________
22. M.C.V. (fl)______________________
23. Serum iron (ìg/dl)_____________________
24. Serum ferritin (ìg/L) __________________
25. Hb (g/dl) (Cyanomethamoglobin method) ____________________
26. PCV (%) ___________
27. TIBC (μg/dl) ___________
28. General Blood Picture for morphology of RBC ______________________
857
31. SGOT (IU/L) ________
32. S. Alkaline phosphatase (U/L) ________
33. S. Proteins (Total) (g/dl) _____________
34. Albumin (g/dl) ________
35. Globulin (g/dl) ________
858
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC OPEN CLINICAL TRIAL OF SELECTED DRUGS IN IRON
DEFICIENCY ANAEMIA
CASE RPORT FORM – V
(Enter a √ in the appropriate box)
2. Center: _______________________
Adverse reactions
8. Burning sensation in Not applicable
abdomen
859
9. Nausea Not applicable
10. Diarrhoea Not applicable
11. Skin rashes Not applicable
12 TC (Cells/Cu. mm.)
DC (%) 13. P 13. P
14. L 14. L
15. E Not applicable Not applicable 15. E
16. M 16. M
17. B 17. B
18 ESR (mm / 1st hour.) Not applicable Not applicable
19 M.C.H.C. (g/dl)
20 M.C.V. (fl)
21 Serum iron (ìg/dl)
22 Serum ferritin (ìg/L)
23 Hb (g/dl)
(Cyanomethamoglobin
method)
24 PCV (%)
25 TIBC (ìg/dl)
26 General Blood
Picture for
morphology of RBC
Liver function tests
S. Bilirubin
27. Total (mg/dl)
28. Direct (mg/dl)
29. SGPT (IU/L)
Not applicable Not applicable
30. SGOT (IU/L)
860
31. S. Alkaline
phosphatase (U/L)
32. S. Proteins (Total)
(g/dl)
33. Albumin (g/dl)
34. Globulin (g/dl)
Renal function tests
35. Blood urea (mg/dl)
Not applicable Not applicable
36. S. Creatinine (mg/dl)
Urine Examination
Routine
37. Sugar
38. Albumin (gm/dl) Not applicable Not applicable
861
49. Status of the subject:
Completed 1
Drop out 2 Reason: ______________________________
Died 3 Cause: _______________________________
862
TO EVALUATE THE SAFETY AND EFFICACY OF
AYUSH-RP IN SICKLE CELL ANEMIA
863
Blank
864
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
TO EVALUATE THE SAFETY AND EFFICACY OF AYUSH-RP IN SICKLE
CELL ANAEMIA
I. BACKGROUND
Sickle Cell Anaemia (SCA) is a chronic hemoglobinopathy characterized by frequent
episodes of painful arises, widespread tissue infarcts causing multisystem dysfunction, chronic
anaemia, increased susceptibility to infection & growth retardation (Francklin Bunn 1987). There
are many genotypes of sickle hemoglobinopathies e.g. Sickle Cell Anaemia, Sicke Cell traint (HbS
trait), S/ß0 thalassemia/Sß + thalassemia haemoglobin SC, SD, SE. The prototype of Sickle
hemoglobinopathy is Sickle Cell anemia, is the homozygous state for HbS. The Sickle Cell Anemia
is caused by a mutation in the ß-globin gm that changes the sixth amino acid from Glutamic acid
to valine HbS ß2ß26Glu’→Val). Hypoxia, pyrexia & acidosis aggravate sickling. The precipitating
cause is not always detectable. The Clinical features of Sickle Cell disorder have got maximum
resemblance with Raktadusti, Jeernajwara, hepatomegaly, splenomegaly) rather than Pandu
Roga as described in Compendiums of Ayurvedic System of Medicine. A variety of drugs like
urea, zinc, cyanate, vitamin-E, magnesium sulphate, cietidil, 5 azamutidine, hyperbolic oxygen and
pentoxifyline, etc. have all produced equivocal results. Recently antibiotic prophylaxis with
splenectomised patient, vigorous hydration with narcotic analgesic. Exchange blood transfusion,
hydroxurea, S-Arginine, folic acid supplements, clotirimazole are the mainstay of treatment but
recent treatment proved to be expensive & toxic side effect (Bone marrow toxicity of
hydroxyurea). Bone marrow transplantation is most effective treatment in modern medicines but it
is too expensive. Therefore, this study aims to evaluate the effect of Ayurvedic drug which has low
cost, probably low toxicity and probably that lessons the sickle cell crises.
II. AIM & OBJECTIVES
The objectives will be to evaluate the changes in frequency of Sickle Cell crisis with
AYUSH-RP in Sickle Cell Anaemia.
References
1. API, Textbook of Medicine 5th Edition Reprint 1994 P.997-998
2. Davidson’s Principle and Practice of Medicine 19th Edition p.926-927
3. Harrison’s is Principle of Internal Medicine 15th Edition 669-671
4. Hemoglobin level and prevention of repeated Blood transfusion in sickle cell disorders with
classical Ayurvedic formulation, R.K.Panda. JRAS XVII, 47-55.
865
III. CENTRES -
Identified CCRAS Institutes.
IV. SAMPLE SIZE AND METHODS
Sample size: 20 subjects per centre.
Drug:
(i) Drug/Dosage/Duration: Ayush-RP 500 2 cap. BID with lukewarm water for six
months before food for six months.
(ii) Design of the study - Open trial (Pilot study)
Duration of the study – 6 months with drug and without follow up for another six
months.
Total period of the study - 2 years. (Recruitment for nine months. Treatment and follow
up for one year and three months for statistical analysis).
V. CRITERIA FOR INCLUSION
1. Age >5 years with or without fever, muscular pain in both extremities & Hepatomegaly.
2. Patients having hemoglobin > 5 gm%.
3. Diagnosed Patients on the basis of peripheral smear for sickling & Haemoglobin
Electrophoresis.
VI. CRITERIA FOR EXCLUSION
4. Patient with Hb% < 5 gm%.
5. Patient with end stage renal disease.
6. Patient with documented infection.
7. Severe liver dysfunction.
8. Patient with acute chest syndrome (Like Respiratory failure, pulmonary edema/ embolism/
infarction.
9. Patient on bone marrow transplant/renal transplant.
VII. CRITERIA FOR WITHDRAWAL
During the course of trial if any serious condition (Liver, kidney and lungs function
deteriorates) develops which requires urgent treatment such subject may be withdrawn from trial
& managed by principle investigator accordingly.
866
VIII. ROUTINE EXAMINATION AND ASSESSMENT
The full details of history and physical examination of the patients will be recorded as per
the proforma (Forms I & IA). Clinical assessment will be done before drug administration, at the
start of the treatment and then monthly during treatment period and follow up period for 6 month.
The laboratory investigations will be recorded before drug administration, at the start of treatment
then monthly during treatment period and follow up.
IX. CRITERIA FOR ASSESSMENT OF RESULT OF TREATMENT
METHOD OF ASSESSMENT:
Two parameters subjective and objective were used for assessment of progress:
i. SUBJECTIVE PARAMETERS: The symptoms e.g. fever, weakness, abdominal
discomfort & pain in extremities observed during the follow up period were grades
0,1,2,3 on the basis of severity and duration. The improvement was confirmed from
favourable shift grade of each sign & symptoms from grade 3-0 as follows.
867
XIII. ETHICAL REVIEW:
A. Ethical Committee (IEC): The proposal will be placed before Ethical Committee (IEC)
of trial center for getting clearance certificate before the project is initiated. Patient’s
information sheet and informed consent form will be submitted along with project proposal
for approval by EC. Both will be maintained in duplicate with one copy given to the
patient at the time of entry to the trial.
B. Data and safety monitoring board: A Data and safety monitoring board (DSMB) at
Hqrs. will carefully monitor the data and side effects during the period of study and put in
a place where by prompt reporting of adverse events occur. The data will be reviewed as
every 20 participants entered the study and administered the trial drugs. The research
team will report immediately to the PI and Data Monitoring Board if, any life threatening
conditions whether they are perceived to be study related or not. The Board decides
whether the adverse effects warrant discontinuation of the study protocol. Protocols will be
written and approved for the treatment of study related adverse events.
868
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
TO EVALUATE THE SAFETY AND EFFICACY OF AYUSH-RP IN SICKLE
CELL ANEMIA
CONSENT FORM
CERTIFICATE BY INVESTIGATOR
I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature of the subject: ______________
Name: ____________________________
CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending Physician, the purpose of the
clinical trial and the nature of drug treatment and follow-up, including the laboratory investigations
to be performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so. I am willing to undergo any risk for inclusion in
this study.
I, exercising my free power of choice, herby give my consent to be included as a subject
in the clinical trial of Ayurvedic drug in Sickle Cell Anaemia.
Relationship ___________________________________
869
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
PROTOCOL TO EVALUATE THE EFFECT OF AYURVEDIC DRUG IN SICKLE
CELL ANAEMIA
PATIENT INFORMATION SHEET
870
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
PROTOCOL TO EVALUATE THE EFFECT OF AYURVEDIC DRUG IN SICKLE
CELL ANAEMIA
CASE REPORT FORM PART-I – SCREENING
1. Centre: ………………..……….
3. Patient No.
5. Address : ..............................................................................................................................
6. Age >5 years with or without fever, muscular pain in both extremities & Hepatomegaly.
8. Diagnosed Patients on the basis of peripheral smear for sickling & Haemoglobin Electrophoresis.
13. Patient with acute chest syndrome (Like Respiratory failure, pulmonary edema/ embolism/
infarction.
If yes to 4-6 & no to 7-12, then patient should be included into the study.
871
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
PROTOCOL FOR TO EVALUATE THE EFFECT OF AYURVEDIC DRUG IN
SICKLE CELL ANAEMIA
CASE REPORT FORM PART-II HISTORY PROFORMA
1. Centre: ………………..……….
3. Patient No.
5. Address : ..............................................................................................................................
7. Educational status:
Christian Parsi
872
Chief Complaints with Duration (in days) Present Absent Duration
13. Fever
14. Weakness
23. Priapism
Past history of illness: History of bleeding from the nose and history of conversion, giddiness
fainting, attack, CVA, if any
873
31. Treatment given so far Ayurvedic medicine Modern medicine
Unani Homoeopathy
Siddha Mixed
_______________________________________________________________________
_______________________________________________________________________
Personal History :
Yes No
32. Smoking
33. Obesity
34. Non-Vegetarian
35. Alocholic
36. Prakriti
Sannipataja
Sama
Physical Examination
874
41. Body temerature :
43. Pulse
44. Respiration
Present Absent
45. Cynosis
46. Anaemia
47. Jaundice
48. Pigmentation
50. Ulcer
51. Lymphadenopathy
Systemic Examination
Normal Abnormal
54. C.N.S.
875
57. Respiratory system
Size in cm.
Size in cm.
Present Absent
60. Tumour/Lump
Avrak dosha
Ksheen dosha
Shukra Oja
Shukra
876
{}
64. Stages of disease (Roga Kriya Kala)
Pranvaha Srotas
877
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
PROTOCOL FOR TO EVALUATE THE EFFECT OF AYURVEDIC DRUG IN
SICKLE CELL ANAEMIA
CASE REPORT FORM III – CLINICAL & PHYSIOLOGICAL ASSESSMENT
(Monthly during treatment period and follow up)
1. Centre: ………………..……….
6. Date of Assessment :
7. Relief in fever
8. Weakness
9. Abdominal discomfort
878
17. Overall clinical assessment by the Doctor:
Continuing (1)
879
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
PROTOCOL FOR TO EVALUATE THE EFFECT OF AYURVEDIC DRUG IN
SICKLE CELL ANAEMIA
(Monthly during treatment and monthly during follow up)
CASE REPORT FORM IV – LABORATORY INVESTIGATIONS
(To be done before, at the end of three months and end of the treatment)
1. Centre: ………………..……….
6. Date of Assessment :
7. Urine Examination
Routine____________ Microscopic___________
8. TC (Cells/Cmm.) __________________________
13. BT
14. CT
880
17. Peripheral smear for sickling (before treatment only)
25. S. Bilirubin
26. SGPT
27. SGOT
29. S. Proteins
881
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882
IMMUNE SYSTEM
SECTION - XV
Blank
884
EVALUATION OF EFFICACY OF AYUSH-QOL-2 IN
HIV INFECTED PERSONS AS AN SUPPORTIVE
THERAPY
885
Blank
886
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
EVALUATION OF EFFICACY OF AYUSH-QOL-2 IN HIV INFECTED
PERSONS AS AN SUPPORTIVE THERAPY
I. BACKGROUND
Acquired immunodeficiency Syndrome1 or AIDS is a disease of the defense system of the
body. The causative organism is Human Immunodeficiency Virus (HIV), which belongs to the
family of human retroviruses. This virus attacks the immune system of the human beings, leading
to depletion of CD4 cells resulting in immunodeficiency. Because of immunodeficiency the person
becomes susceptible to various secondary infections and neoplasm that are AIDS-definiting illness.
The World Health Organisation estimates that there are over 1.75 millions HIV infected
adults throughout India. In majority of cases infection occur through sexual route and rest through
blood transfusion, injecting drugs etc.
There are four broad approaches to the treatment of HIV infection. These include 1.
Treatment or prophylaxis of specific opportunistic infections 2. General management 3. Anti
retroviral agents, which include reverse transcriptase (RT) inhibitors and proteinase inhibitors 4.
Immunorestorative therapy.
Presently Zidovadine (AZT), Didanosine, Zalcitabine and Lamivudine are available RT-
inhibitors; Saquinavir, Kitovavir and Indinovir are the available proteinase inhibitors.
However, the major limitations of these drugs to be used in our country include 1.
Restricted availability in our country. 2. Major side effect 3. High cost 4. Unequivocal findings in
their role in preventing progression to AIDS related complex (ARC) or AIDS.
WHO had noticed inability of people in developing countries to purchase costly medicines
used in the treatment of AIDS. Hence it is trying to promote indigenous drugs available in these
countries, through scientific study.
Since the initial recognisition of the clinical manifestations of HIV-1 infection are the result
of declining cellular and humoral immune responsiveness, there have been a number of efforts to
reverse this decline through the use of a) agents with putative general immune enhancing activity
and b) recombinant cytokines. However, these are complicate both by uncertainty of mechanism
in terms of agents with putative general immune enhancing activity and by the complex immune
regulatory milieu in which either general immune modulators or cytokines are used.
Immune based therapeutic intervention for HIV-1 infection may be divided into two broad
categories. These include reconstitution of general immune responsiveness and augmenting HIV-
1 specific immune responses.
1. Harrison’s Principle of Internal medicine: 15th Edition
887
The development of highly active antiretroviral drugs, especially protease inhibitors, has
resulted in the identification of potent combination regimens that clearly serve as the main stay of
current therapy for HIV infection. However, despite the profound suppression of viral replication
that can be seen with these combination therapies, the level of immune restoration associated with
such therapies appear to be limited in many patients. Furthermore, the duration of viral suppression
in many patients is also limited, especially for those with long exposure histories to many of the
available antiretroviral drugs, which were often utilized sequentially as single agents. Thus
identification of effective alternative therapeutic approaches for the treatment of HIV-infected
patients is essential.
Some studies showed that Ayurvedic preparations were effective only if used as
prophylactic and not if used as curative. They produce most of their effects by primarily acting on
the immune system. It had been shown that Ayurvedic preparations, given to rats whose
macrophages have been overloaded with a fat lipofyundin, were unable to stimulate macrophages
and thus proving that stress induced damage is no preventable.
Ayurvedic preparations act primarily by activating the macrophages. It increases the
phagocytic activity of macrophages and also induces expression of MHC-II antigens indicating
enhancement of their antigen-presenting ability. In vitro, treatment of mice splenocytes with
Ayurvedic preparations stimulated the production of II-2, IFN-Gamma and TNF-Alpha reflecting
activation of Th-1 type of T cell responses. Since Th-1 type of response has been implicated with
the cell mediated immunity the therapeutic effect of Ayurvedic preparation, as reported may be
mediated by activation of cellular immune responses. In fact, the antimicrobial properties of
Ayurvedic preparation have found to be mediated by the immune system.
In the Indian scenario, Ayurveda could possibly contribute in this respect by using rasayana
and balya oushadi dravyas. The development of immune-potentiators with Ayurvedic drugs has
opened an entirely new chapter in therapeutics.
In AIDS the patient losses something essential. The cellular immunity becomes defenseless
against the pathogens and suffers from various clinical manifestations. These manifestations are
similar to that of OJOKSHAYA2-3 or BALAKSHAYA patients, depicted in Ayurvedic classics.
By administrating the rasayana medicaments meant for ojovardhaka, balavardhaka which will
promote the process of dhatu poshana and enrich ojus and thus leads to improve the vital
strength and immunity or vyadhi kshamatva (non-specific immunity).
2. Charaka Samhita, Sutra Sthana Chapter – 17/73, Vidyotini Hindi Vyakhya by Vd. Ambikadatta
Shastry, Choukhamba Orientalia, Varanasi
3. Ambika Dutta Sashtri (1989) Susruta Samhita (text with Hindi commentary), Sutra Sthana, Chapter
15/24, VIIth, Edition Chaukhamba Sanskrit Series Office, Varanasi.
888
If AIDS is treated in this way, it may lead to break through for newer views in solving the
problem.
Hence the present study is designed to evaluate efficiency of certain selected Ayurvedic
formulations in HIV/AIDS patients as a supportive therapy for improving quality of life. The
selected drug will be evaluated for its rasayana and balya properties.
II. OBJECTIVE
The study is aimed to evaluate the efficacy of the Ayush-QOL-2 in HIV infected persons,
as a supportive therapy for the improvement of quality of life.
III. CENTRES
CCRAS identified centers.
889
V. CRITERIA FOR INCLUSION:
1. Age group – 20 to 60 irrespective of sex
2. Seropositive to HIV-1 or HIV-2 or both
3. Western Blot positive
4. CD4 count ranging from 200-500/cu. mm
5. Hb gm% at least 7 gm%
6. Patients with normal hepatic and renal function
7. Patients with total lymphocyte count 2000/cu.mm and platelet counts 75000/cu.mm
8. Able to understand and give written consent
890
• Severe adverse effect of the drug.
A. Clinical parameters:
i. Weight gain
ii. Improvement of Karnofsky performance score
iii. Reduction in opportunistic infections
iv. Improvement in clinical status of the patient (subjective scales of measurement of
symptomatic improvement 0=Static; 1=Mildly better; 2=Moderately better;
3=Much better)
B. Laboratory investigations:
i. Increase in CD4 count
ii. Decrease in Beta-2 micro globulin level
iii. Decrease in viral load
iv. Increase in Hb%
X. STATISTICAL ANALYSIS
Before treatment and after treatment data on clinical and laboratory parameters taken into
account for diagnosis and for the assessment of results of treatment will be tabulated and analysed
891
using suitable statistical method.
892
APPENDIX
KARNOFSKY PERFORMANCE SCORE REFERENCE SHEET
Unable to work; Able to live at home; Care for most personal needs; A varying amount of
assistance is needed
70 Cares for self; Unable to carry on normal activity (or) to do active work.
60 Requires occasional assistance and frequent medical care
50 Requires considerable assistance and frequent medical care.
Unable to care for self; requires equivalent of institutional or hospital care; Disease may be
progressing rapidly
40 Disabled; Requires special care and assistance.
30 Severely disabled, hospitalization is indicated, though death is not imminent.
20 Very sick; Hospitalization is necessary; Active supportive treatment is necessary.
10 Moribund; Fatal processes are progressing rapidly.
0 Dead
893
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
WRITTEN INFORMED CONSENT FORM
CERTIFICATE BY INVESTIGATOR
I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending physician, the purpose of the
clinical trial and the nature of drug treatment and follow-up, including the laboratory investigations
to be performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so. I am willing to undergo any risk for inclusion in
this study.
I, exercising my free power of choice, hereby give my consent to be included as
a subject in the clinical trial on “Evaluation of Efficacy of Ayush QOL-2 in HIV Infected
Persons as an Supportive Therapy”
894
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
EVALUATION OF EFFICACY OF AYUSH-QOL-2 IN HIV INFECTED
PERSONS AS AN SUPPORTIVE THERAPY
PATIENT INFORMATION SHEET
895
categories. These include reconstitution of general immune responsiveness and augmenting HIV-
1 specific immune responses.
The development of highly active antiretroviral drugs, especially protease inhibitors, has
resulted in the identification of potent combination regimens that clearly serve as the main stay of
current therapy for HIV infection. However, despite the profound suppression of viral replication
that can be seen with these combination therapies, the level of immune restoration associated with
such therapies appear to be limited in many patients. Furthermore, the duration of viral suppression
in many patients is also limited, especially for those with long exposure histories to many of the
available antiretroviral drugs, which were often utilized sequentially as single agents. Thus
identification of effective alternative therapeutic approaches for the treatment of HIV-infected
patients is essential.
Some studies showed that Ayurvedic preparations were effective only if used as
prophylactic and not if used as curative. They produce most of their effects by primarily acting on
the immune system. It had been shown that Ayurvedic preparations, given to rats whose
macrophages have been overloaded with a fat lipofyundin, were unable to stimulate macrophages
and thus proving that stress induced damage is no preventable.
Ayurvedic preparations act primarily by activating the macrophages. It increases the
phagocytic activity of macrophages and also induces expression of MHC-II antigens indicating
enhancement of their antigen-presenting ability. In vitro, treatment of mice splenocytes with
Ayurvedic preparations stimulated the production of II-2, IFN-Gamma and TNF-Alpha reflecting
activation of Th-1 type of T cell responses. Since Th-1 type of response has been implicated with
the cell mediated immunity the therapeutic effect of Ayurvedic preparation, as reported may be
mediated by activation of cellular immune responses. In fact, the antimicrobial properties of
Ayurvedic preparation have found to be mediated by the immune system.
In the Indian scenario, Ayurveda could possibly contribute in this respect by using rasayana
and balya oushadi dravyas. The development of immune-potentiators with Ayurvedic drugs has
opened an entirely new chapter in therapeutics.
In AIDS the patient losses something essential. The cellular immunity becomes defenseless
against the pathogens and suffers from various clinical manifestations. These manifestations are
similar to that of OJOKSHAYA - or BALAKSHAYA patients, depicted in Ayurvedic classics.
By administrating the rasayana medicaments meant for ojovardhaka, balavardhaka which will
promote the process of dhatu poshana and enrich ojus and thus leads to improve the vital
strength and immunity or vyadhi kshamatva (non-specific immunity). If AIDS is treated in this
way, it may lead to break through for newer views in solving the problem.
896
What will you have to do?
Your doctor will explain clearly what you have to do. It is important that you follow the
instructions scrupulously. The study will take approximately 180 days. During treatment period,
you are expected to visit the hospital in 30 days interval for clinical and physiological assessment.
Before you start treatment, during the first visit to the clinic, you will undergo a complete
physical examination, required objective tests and laboratory investigations will also be done.
If you are found eligible, you would be put on trial treatment for 6 months.
At each visit, you will be supplied with sufficient quantities of drugs to last until
your next visit. If any adverse reactions like skin allergy, nausea, vomiting and
palpitation/tremor etc., noticed during the treatment period, this should be noticed to the
Principal Investigator.
897
EVALUATION OF EFFICACY OF AYUSH-QOL-2 IN HIV INFECTED
PERSONS AS AN SUPPORTIVE THERAPY
EVALUATION OF EFFICACY OF AYUSH-QOL-2 IN HIV/AIDS PATIENTS
CASE REPORT FORM -I SCREENING
1. Code No. (of clinical trial)
2. Centre _______________________________________
6. Address: ______________________________________________________________
898
pneumocystis, carinii pneumonia, toxoplasmosis.
12. Patients suffering from secondary infections or
opportunistic infections
13. Patients with neoplasms
899
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
EVALUATION OF EFFICACY OF AYUSH-QOL-2 IN HIV INFECTED
PERSONS AS AN SUPPORTIVE THERAPY
CASE REPORT FORM-II HISTORY
(Enter a √ in the appropriate box)
1. Code No. (of clinical trial)
2. Centre __________________________________
900
If yes
13. History of exposure towards No Yes No. of Month/year Place
medical causes (0) (1) times Latest episode
1. Blood transfusion
2. Blood products
3. Major surgery
4. I.V drug use
5. Needle pricks/Needle stick injury
6. Other relevant causes
2. Consumption of alcohol
3. Smoking habit
901
18. Examination of the Patient
A. General Examination No (0) Yes (1) If yes, duration
(in months)
1. Fatigue
2. Fever
3. Night sweats
4. Anorexia
5. Weight loss
6. Diarrhoea
7. Cough
8. Breathlessness
9. Headache
10.Vomiting
11.Oedema
12.Dermatitis
13.Herpes
14.Any others
2. Cardiovascular system
3. Gastro-Intestinal system
902
4. Central nervous system
5. Genito-Urinary system
1. Pallor
2. Icterus
3. Cyanosis
Central/Peripheral)
4. Clubbing
5. Koilonychia
6. Oedema
a. Legs
b. Face
c. General
7. Lymphadenopathy
D. Anthropometry:
1. Height (in cm): _______________
2. Weight (in Kg): _______________
903
3. Chest circumference (in cm): _______________
4. Abdominal circumference (in cm): _______________
5. Mid arm circumference (in cm): _______________
6. Thigh circumference (in cm): _______________
19. Past Drug Schedule
904
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
EVALUATION OF EFFICACY OF AYUSH-QOL-2 IN HIV INFECTED
PERSONS AS AN SUPPORTIVE THERAPY
CASE REPORT FORM-III LABORATORY INVESTIGATIONS
(All investigations to be carried out during pre-entry screening level. During treatment CD4
count, Beta-2 micro globulin level, Viral load and gm% of haemoglobin will be done at every
two months interval)
General Information
1. Code No. (of clinical trial)
2. Centre _____________________
3. Sl. No. of the subject:
4. Name of the patient_______________________________________________________
5. Gender: Male 1 Female 2
Blood Tests
Negative (0) Positive (1)
905
16. ESR (1 hour) : ________________ 10-20 mm
17. Leucocyte count : ________________ 4,000-10,000/¼L
18. Neutrophil count : ________________ 40-60%
Lymphocyte Count
19. Total T-Lymphocyte count : ________________ 60-88%
20. Total CD4 count : ________________ 32-66%
21. Total CD8 count : ________________ 10-43%
22. CD4 : CD8 ratio : ________________ 1
23. Platelet count : ________________ 150,000-400,000/¼L
Blood Chemistry
24. VDRL Negtive (0) Positive(1) (titre:____________)
25. HBV testing Negtive (0) Positive(1) (titre:____________)
26. Blood sugar (mg%) : ________________ 60-100 mg/100 ml
27. Blood urea (mg%) : ________________ 14-38 mg/ 100 ml
28. Serum Creatinine (mg%) : ________________ 0.5-1.8 mg/100 ml
29. Serum Uric acid (mg%) : ________________ 2.0-6.0 mg/100 ml
30. Serum Bilirubin (mg%) : ________________ 0.1-0.8 mg/100 ml
31. SGOT (IU) : ________________ 0.20 IU/ml
32. SGPT (IU) : ________________ 0.15 IU/ml
Proteins (gm%)
33. Total protein : ________________ 6-18 gm/dl
34. Albumin : ________________ 3.5-5.5 gm/dl
35. Globulin : ________________ 2.0-3.6 gm/dl
36. Prothrombin time (sec.) : Normal 11-14_________(Control)________(Patient)
906
Skin Sensitivity Test (With 5 units)
37. Mantoux test (mm) : ________________ Normal 10 mm
38. Urine
Routine _______________________________________________________________
Microscopic___________________________________________________________
39. Stool Examination
Routine ________________________________________________________________
Microscopic___________________________________________________________
40. Chest X-ray : _________________________________________________________
41. ECG : _________________________________________________________
Final Diagnosis
Stage IV (4)
907
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
EVALUATION OF EFFICACY OF AYUSH-QOL-2 IN HIV INFECTED
PERSONS AS AN SUPPORTIVE THERAPY
CASE REPORT FORM-IV ASSESSMENT
1. Code No. (of clinical trial)
2. Centre _____________________
3. Sl. No. of the subject:
4. Name of the patient______________________________________________________
5. Gender: Male 1 Female 2
7. Clinical Parameters
Clinical (Parameters) Before the trial Follow-up period (in months)
i. Weight 0 1 2 3 4 5 6
ii. Karnofsky (Performance) score
iii. Incidences of opportunistic infections
iv. Clinical status of the patient
1. Fatigue
2. Fever
3. Night sweats
4. Anorexia
5. Diarrhoea
6. Cough
7. Breathlessness
8. Headache
9. Vomitting
10. Oedema
908
11. Dermatitis
12. Herpes
13. Any others
8. Laboratory Parameters
Laboratory Parameters Before the trial Follow-up period (in months)
0 2 4 6
v. CD4 Count
vi. Bet-2 micro globulin level
vii. Viral load
viii. Haemoglobin (gm%)
11. Was the patient withdrawn from the trial? No (0) Yes (1)
909
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910
DISORDERS OF SKIN
SECTION - XVI
Blank
912
EVALUATION OF THE THERAPEUTIC EFFECT OF
SINGLE DRUGS/COMPOUND AYURVEDIC
FORMULATIONS AND SHODHANA THERAPY IN THE
MANAGEMENT OF KITIBHA (PSORIASIS)
913
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914
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA
AND SIDDHA
EVALUATION OF THE THERAPEUTIC EFFECT OF SINGLE DRUGS/
COMPOUND AYURVEDIC FORMULATIONS AND SHODHANA THERAPY IN
THE MANAGEMENT OF KITIBHA (PSORIASIS)
I. BACKGROUND:
Psoriasis1 is a common chronic non-infectious skin disease said to be idiopathic, according
to modern medicine. In Ayurveda the causative factors of skin disease are elaborately classified.
Continued practice of Apathya Aharavihara and Manovriti, the doshas and dhatus are vitiated and
cause Kitibha. In Kitibha vatakapha doshas are predominantly involved and this disease is
included under the category of ‘Kshudra Kushtha’. Kitibha is roughly compared and accepted
with Psoriasis of Modern Medical diagnosis. Cases characterized with well defined erythematus
plaques with large adherent silvery scale with exfoliation are taken up for study.
The preliminary clinical trials with Kaisoraguggulu, Arogyavardhini and Nimbidin were
conducted earlier with different external applications groups of Samana therapy and one groups of
Shodhana therapy along with rasayana treatment is taken up for clinical evaluation. This study is
conducted in O.P.D and I.P.D. levels.
AYURVEDIC LITERATURE
Earlier studies in Kitibha confirmed that, this disease can be equated with Psoriasis
especially with stable plaque Proriasis. The signs and symptoms of Kitibha shown below are
almost identical with Psoriasis.
1. Ruksha - Dryness of the skin
2. Kinakharasparsa - Hard an torturous skin
3. Kandu - Itching
4. Parushya - Roughness
5. Asita - Hyperpigmentation
1 References: Charaka Samhita, Chikitsa Sthana Chapter– 7, Vidyotini Hindi Vyakhya by Vd. Ambikadatta
Shastry, Choukhamba Orientalia, Varanasi
915
As per Ayurvedic concept, Kitibha is classified under Kshudra Kushtha. The line of
treatment for Kitibha is based in the general treatment of kushtharoga. The main treatment is
sodhana followed by Samana and Rasayana therapy. Many single and compound herbal and
herbomineral preparations are mentioned in Ayurvedic classics and text books. Plant origin drugs
like Nimba, Bhallataka, Aragwadha, Madhusnuhi, Khadira, Majishta, Haridra, Guduchi, Bakuchi,
Chakramarda, Guggulu, Karanja etc. mineral origin drugs like Rasa, Gandhaka etc and animal
origins like Gomutra, Ghee etc. are some of the drugs used alone and as ingredients in many
important compound preparations in various Kushtarogas.
Although there are many single and compound medicines prescribed for the treatment of
Kushtharogas there is no special scientific study carried out in single or compound drugs to
evaluate their therapeutic effect in a particular disease like Kitibha. So here are a few group of
drugs are giving to evaluate their therapeutic effect in Kitibha.
MODERN CONCEPT
In Psoriasis, main abnormality is of increased epidermal proliferation due to excessive
multiplication of cells in the basal layers. The transit time of keratinosite shortened and epidermal
turn over is reduced from 28 to 34 days. Even though the etiology is unknown, the factors
involved are genetic, biochemical, immunopathological and dermal. These factors may not be fully
sufficient to develop Psoriasis, precipitating factors like trauma, infections, sunlight some drugs and
emotions may cause flare up of the disease. There are different types of Psoriasis like Stable
Plaque Psoriasis, Guttate Psoriasis, Erythrodermic Psoriasis, Pustular Psoriasis. Of these, Stable
plaque Psoriasis is dry silvery white scales. The elbow, knee, lower back are commonly involved
areas, other sites include are scalp, nails, flexures, palm and napkin area.
Guttate Psoriasis is common in children and adolescents. The rashes often appear rapidly
and lesions are small, scaly and drop-let shape. Usually the lesions plaque disappears in a few
months, but later it may develop into plaque pattern. Erythrodermic lesions are red and scaly.
Shivering is also severe in this group due to considerable heat loss. In Pustular Psoriasis, sudden
onset with myriads of small sterile pustule erupting on an erythematous base. This type is
generalized from which is rare but serious type and it requires hospitalization. Localized form is
more common and involve mostly in palm and soles. The eruption consists of numerous small
sterile pustule lying on an erythematous base.Psoriatic arthropathy involves terminal interphalangeal
of toes and fingers and larger joints like sacroiliac joints and lumbarspine.Coaltar preparations,
calcipotriol, retinoides, corticosteroids an ultraviolet radiation are the local measures to manage
Psoriasis. The systemic treatment commonly used are photo chemotherapy with PUVA, retinoides,
mothotrexate and cyclosporine-A under regular specialist supervision. Systemic treatment is given
only when the local measures fail to respond.
916
II. OBJECTIVES
To evaluate the therapeutic effect of single drugs/compound Ayurvedic formulations and
Shodhana therapy in the management of Kitibha (Psoriasis).
DOSE SCHEDULE
Group 1:
- Arogyavardhini 500 mg along with Kaisoraguggulu 1 mg thrice daily for 3 months.
- Chakramarda Keratailam for external application
Group 2:
- Panchanimba lauha churna 2 gms, Kamadudha rasa 250 mg and haridrakhanda 3 gm
(mix together in a single dose) twice daily.
Group 3:
- Snehapana for 7 days with Mahatiktaka Ghrita, Mrudu Swedana for one day.
917
- and Samsarjana
- Then after Rasayanaprayoga with Bhallataka for 3 months.
- Shodhana
V. EXCLUSION CRITERIA
Age below 15 years and above 60 years, patients suffering from any severe systemic
disease like Diabetes, Renal disease, H/O Liver disease, in the recent past VDRL positive cases
will be excluded form the trial.
Patients with other forms of Psoriasis like Guttate, Pustular, Erythrodermic, Psoriatic
arthropathy and patients addicted to alcohol will not be included in the trial.
918
VIII. CRITERIA FOR ASSESSMENT OF RESULTS
Result of the treatment will be graded as follows:
1. Complete relief:
(a) 100% relief of sign and symptoms of the disease indicated under the head of
diagnosis.
(b) Complete disappearance of the disease as evident in the colour photographic
assessment.
(c) Favorable alterations in the laboratory investigations.
(d) Considerable improvement in the general well being of the patient (Both subjective
an objective).
2. Marked relief:
(a) 76% to 99% relief. Improvement of the presenting clinical symptoms of the disease
recorded earlier.
(b) Significant change in the skin lesions observed in the photographic assessment.
(c) Satisfactory change in the laboratory investigations.
(d) Overall improvement in the well being of the patients.
3. Moderate relief:
(a) 51% to 75% relief in signs and symptoms recorded earlier.
(b) Satisfactory change in the skin lesions observed in the photographic assessments.
(c) No change in the laboratory investigations
(d) Satisfactory improvement in the general well being of the patient.
4. Mild relief:
(a) 10% to 50% improvement in the clinical symptoms of the disease.
(b) No change in laboratory findings.
(c) Mild improvement in the well being of the patient.
5. No relief:
(a) No relief or below 10% improvement
(b) No change in laboratory findings
(c) No change in photographic assessment
919
(d) No improvement in the well doing of the patient.
920
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
WRITTEN INFORMED CONSENT FORM
CERTIFICATE BY INVESTIGATOR
I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending physician, the purpose of the
clinical trial and the nature of drug treatment and follow-up, including the laboratory investigations
to be performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so. I am willing to undergo any risk for inclusion in
this study.
I, exercising my free power of choice, hereby give my consent to be included as a
subject in the clinical trial on “Evaluation of the therapeutic effect of single drugs/compound
Ayurvedic formulations and Shodhana therapy in the management of Kitibha (Psoriasis).”
921
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
EVALUATION OF THE THERAPEUTIC EFFECT OF SINGLE DRUGS/
COMPOUND AYURVEDIC FORMULATIONS AND SHODHANA THERAPY IN
THE MANAGEMENT OF KITIBHA (PSORIASIS)
PATIENT INFORMATION SHEET
922
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
EVALUATION OF SINGLE/COMPOUND/HERBOMINERAL COMPOUND
DRUGS
CASE REPORT FORM I- SCREENING
1. Name of the patient: ..............................................Age: ................ Sex: .......................
2. Address: .................................................................................................................................
3. Centre: ..................................................................
5. Patient No.
2. Kandu
3. Ruksha
4. Parushya
5 Rekamandala
6. Twakvigalana
7. Nuna Twakvivarnya
8. Ati Twakvaivarnya
9. Acute Guttate
10. Flexular
11. Pustular
923
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF SINGLE/COMPOUND/HERBOMINERAL
COMPOUND DRUGS
CASE REPORT FORM II – HISTORY
4. Center: .................................................................................................................................
6. Patient No:
7. Group No: 1 2 3
8. Educational status:
Illiterate 1 Read and Write 2 Primary School 3
Middle School 4 High School 5 College 6
Other (specify) 7 I.N.A. 8
9. Occupation:
Desk work 1 Field work 2
Field work with physical labour 3
Field work with intellectual 4
Indicate nature of work: ...........................................................................................
Total income of the family (in Rs.): ...........................................................................
924
Christian 4 Parsi 5
13. Marital Status: Married 1 Unmarried 2 Widow 3
Divorced 4 Widower 5
14. Result: Good Response 1 Fair Response 2 Poor Response 3
No Response 4 Drop out 5 Lama 6
Death 7
CHIEF COMPLAINTS WITH DURATION
Present Absent Duration (in days)
15. Itching:
17. Roughness:
19. Exfoliation:
21. Hypo-Pigmentation:
22. Maceration:
24. Papule/Pustule/Vesicle
25. Fissures:
Unani Homeopathy
925
Mixed
PERSONAL HISTORY
926
Vata-Kaphaj Vata-Pittaja Pittaja-Kaphaja
PHYSICAL EXAMINATION
52. Pulse:
53. Respiration:
Present Absent
54. Cyanosis:
55. Anaemia:
56. Jaundice:
57. Pigmentation:
59. Deformation:
60. Lymphadenopathy:
927
SYSTEMATIC EXAMINATION
Normal Abnormal
66. Anubandha:
Shukra Oja
928
Sthana Sanshraya Vyakti Bheda
Avipaka Chardi
(Indigestion) (Vomiting)
Hrillas Gaurava
(Water brash) (Feeling of heaviness)
Tandra Avasada
(Drowsiness) (Depression)
Klaibya Karshya
(Loss of libido) (Emaciation)
Agnimandya
(Indigestion)
929
(e). Raktavaha Srotas: Pidaka Rakta pitta
(Boils) (Bleeding from any of the
orifice)
Gandamala Upjihvika
(Cervical lymphadenitis) (Epiglottis)
Adhimamsa Putimamsa
(Protuberance of flesh) (Decayed flesh/Gangrene)
Tandra Dehachikkanata
(Drowsiness) (Greasiness of the skin)
Alasya
(Lethargy)
930
(j). Shukravaha Srotas: Klaibya Aharshana
(Infertility) (Loss of erection)
Sashoola Mutrata
(Painful micturation)
Parushya Lomaharsha
(Roughness of the skin) (Horripulation)
Anga Paridaha
(Burning sensation in the body)
72. Provisional Diagnosis
73. Final Diagnosis
74. Medical Management
75. Prinicipal drug therapy
Dose :.............................................................................................................................
931
Vehicle :.............................................................................................................................
Diet :.............................................................................................................................
Summary of findings: ..............................................................................................................
..........................................................................................................................................
..........................................................................................................................................
932
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF SINGLE/COMPOUND/HERBOMINERAL
COMPOUND DRUGS
CASE REPORT FORM III – FOR PERIODICAL OBSERVATION &
ASSESSMENT
6. Global Assessment
i. Objective
ii. Subjective
iii. Body Weight
iv. B.P.
933
v. Pulse Rate
7. Clinical Pathological
i. Urine a). Macroscopic
b). Microscopic
934
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF SINGLE/COMPOUND/HERBOMINERAL
COMPOUND DRUGS
1. Center: ......................................................
3. Patient No:
4. Group No: 1 2 3
================================== ======
Investigation At the time After 15 30 days 45 days 60 days 75 days 90 days
of admission days
1 2 3 4 5 6 7 8
5. Urine Sugar
6. Albumin
7. Pus Cell
8. Cast
9. R.B.C.
935
HEAMATOLOGICAL INVESTIGATION
16. Blood
Hb%
TLC
DLC
(in thousand)
Polymorph
Lymphocyte
Basophil
Monocyte
Eosinophyl
E.S.R.
P.C.V.
Bleeding Time
Prothrombin time
BIOCHEMISTRY INVESTIGATIONS
17. Protein total
18. Albumin Globulin
Ratio
19. Blood Glucose
20. Urea
21. Uric Acid
22. Bilirubin
23. Serum Cholesterol
24. Serum Alkaline
Phosphatase
936
25. Serum Acid
Phosphatase
26. S. G. O. T.
27. S. G. P. T.
28. Triglycerides
29. Total lipid
30. Createnine
Positive Negative
32. V.D.R.L.
RADIOLOGICAL INVESTIGATIONS
Normal Abnormal
34. X-ray
35. Abdomen
937
39. Skull (AP & Lateral view)
40. I.V.P.
41. Cholecystography
43. Ba-enema
938
P. V. C.
Total Area Infected
939
Blank
940
REPRODUCTIVE AND CHILD
HEALTH CARE
SECTION - XVII
BLANK
942
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
To evaluate the efficacy of AYUSH AG TAB in management of Anaemia, loss of
appetite, leg crams, Bodyache, Weakness during Pregnancy etc.
I. BACKGROUND:
Despite of advanced technology, a high number of women continue to die during childbirth,
due to any cause, related to or aggravated by the Pregnancy or its management. Every minute,
the loss of a woman, shatters a family. Woman’s health have been neglected since many decades
due to gender inequality, poverty, illiteracy, working for the survival of mother is a human rights
imperative.
Pregnancy is a dynamic state, lot of physiological changes take place in hemodynamic and
other systems of pregnant woman in order to adopt the increasing demands of the growing fetus.
Ayurvedic classics had prescribed a particular diet and drug schedule for pregnant women.
These regimens support the pregnant women all through the antenatal, Intranatal and postnatal
period. The antenatal care is mainly intended to provide optimum nourishment to mother and
fetus; it prepares the reproductive system to withstand the changes during antenatal and intranatal
periods. It facilitates the metabolism of the growing fetus and prevents the obstetrical
complications.
II AIM:
1. To care minor ailments of pregnancy like vomiting, constipation, indigestion, minor
oedema etc.
2. To minimise obstetric complications such as pre-eclampsic problems, anemia, cervical
dystocia etc, to lower maternal and fetal mortality and morbidity etc.
III. Centres of the Study: 3 (three)
IV Sample size and Methods: 60
Sample size: Total case – 60, (20 each in three centres).
V. Investigational product and doses:
AYUSH –AG tablet – 500mg tab TDS from 3rd month onwards to till delivery
Vehicle – Milk or water
943
VI. CRITERIA OF INCLUSION:
1. Pregnant women in the IIIrd month of Ist trimester with singleton pregnancy
2. Hb % between 8 and 10.5 gm/dl & Ferritin level less than 13 mg/l
3. Pregnancy not associated with any pre-existing medical illness such as TB, Epilepsy,
Hypertension, Diabetes, Severe anaemia etc
4. Age between 18 and 35 years
5. Pregnancy not associated with any Obstetric complications such as Ante-partum
hemorrhage, Multiple Gestations, Partial Hydatidiform Mole, Pre-eclamptic,
Toxemia, Pregnancy Induced Hypertension, Malformations of pelvis, Rh-
Incompatibility, Bad Obstetric History etc.
6. Pregnancy not associated with any Gynecological complications such as Fibroid
uterus, Ovarian cyst, Cervical carcinoma, Genital prolapse etc.
VII. CRITERIA OF EXCLUSION:
1. Age below 18 and above 35 years
2. Pregnant women in the III trimester
3. Pregnancy associated with pre-existing medical illness like TB, Epilepsy, Hypertension,
Diabetes, Heart disease and severe anemia etc.
4. Grand multi-Para
5. Pregnancy associated with any Gynecological complications such as Fibroid uterus,
Ovarian cyst, Cervical carcinoma, Genital prolapse etc.
6. Pregnancy associated with any Obstetric complications such as Ante-partum
hemorrhage, Multiple Gestations, Partial Hydatidiform Mole, Pre-eclamptic Toxemia,
Pregnancy Induced Hypertension, Malformations of pelvis, Rh-Incompatibility, Bad
Obstetric History etc.
VIII. CRITERIA OF WITHDRAWAL:
1. 100% non-compliance
2. Irregular follow-ups
3. Pregnant woman developing severe obstetric complications
4. Non-availability of the selected cases
944
IX. ROUTINE EXAMINATION AND ASSESSMENT:
The full details of History and Physical Examination of the pregnant women will be
recorded as per the Proforma (form I & IA).
First visit of the pregnant woman will be considered as the initial assessment (whether it is
I or II trimester). Monthly follow up till 6th month, Fortnightly follow up –7th & 8th months,
weekly follow up 9th month to till term, Oedema – weekly follow-up.
X. PERIOD OF STUDY:
7 months for each case. Total duration will be 6 months (For Ayush PG tablet) to
complete the trial at each centre.
XI. FOLLOW-UP:
To be followed up to delivery
XIII. CRITERIA FOR ASSESSMENT OF RESULTS:
Assessment of outcome of Pregnancy:
1. To assess the outcome of delivery as abortion, live birth and still birth
2. Type of delivery as Normal vertex, Breach, Instrumental or Caesarian section
The outcome of this programme will be considered significant if;
i) The woman passes antenatal period without any major complication
ii) Delivery being normal vaginal delivery
iii) Minimal third stage bleeding with normal expulsion of placenta – uncomplicated third
stage
iv) Giving birth to a normal, healthy, live child
XIV. STATISTICAL ANALYSIS:
Data of abortion, live birth, still birth and the type of delivery namely Normal vertex,
Breach, Instrumental and Caesarian will be completed and tabulated and analyzed using
appropriate statistical methods.
XV. TRIAL MONITORING AND DATA ANALYSIS:
The progress of the trial will be monitored by field visit by monitoring unit of CCRAS.
Data analysis will be undertaken at the monitoring unit of CCRAS.
XVI. ETHICAL REVIEW:
Each participating Centres Institutional Ethical Committee (IEC) or Head of the Institution
should give clearance certificate before the trial is initiated.
945
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
Proforma - Antenatal Care
FORM-I: SCREENING PROFORMA
946
of pelvis, Rh - Incompatibility, Bad Obstetric History etc.
15. Pregnancy associated with Gynecological complications such as Fibroid uterus, Cervical
carcinoma, Genital prolapse, Ovarian cyst etc.
If ‘Yes’ to the 6-10 and ‘No’ to 11-15 above, recruit the subject for the trial, if recruited, subject
serial No._____________
947
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
FORM - IA : HISTORY PROFORMA
948
Chronic illness: Allergy:
Surgery: Communicable diseases
FAMILY HISTORY:
1). Type of family: Nuclear No. of persons:
Joint: No. of persons:
2). Diseases: Chronic illness:
Hypertension: Diabetes
Genetic disorders: (specify)
Psychiatric disorder:
Other:
3). History of Multiple births, Molar pregnancy, Large baby, Post dated labour etc.
PAST MENSTRUAL HISTORY:
Menarche:
Menstruation - Duration Flow:
- Interval:
MARITAL HISTORY:
Age of marriage: Marital life (in years):
Consanguineous: Yes/No
PERSONAL HISTORY:
Dietary Pattern - Vegetarian: Non-Vegetarian:
Likes:
Habits: Smoking/Drinking/Chewing Pan/Tobacco:
HISTORY OF PREVIOUS PREGNANCY:
S.N Year Full Pre Post Abortion Type of Baby
term term term Delivery Sex Alive Stillborn Weight
949
1). Instrumental delivery
2). IUFD
3). Hemorrhage- Antepartum: Intrapartum:
4). Bad Obstetric History (History of 3 or > abortion or fetal deaths)
5). Neonatal death: Reason:
6). Previous Caesarian Section: Reason:
7). PET / Eclampsia:
8). Ayurveda care taken during previous pregnancies: Y/N
HISTORY OF PRESENT PREGNANCY:
1). Nausea / Vomiting 10). Vaginal bleeding: I TM - II TM - III TM-
2). Heart burn 11). Oedema
3). Indigestion 12). Hb < 8gms %
4). Constipation 13). Heart disease
5). Giddiness 14). Diabetes
6). Hypertension 15). Uterine irritation/contractions
7). Varicose veins 16). Leg cramps
8). Hemorrhoids 17). Insomnia
9). Tingling & formication
Medication:
1). Whether received TT during this pregnancy: No. of doses
2). Whether received IFA, Calcium during this pregnancy
3). Any other medication
CLINICAL EXAMINATION:
General Examination: Blood Pressure: TPR:
1. Height 2. Weight
3. Head & Neck: Eyes: Mouth:
Neck: -Lymph gland
-Thyroid gland
4. Thorax:
950
Inspection: Breast: Nipple condition - Cracks Depression
Areola condition
Auscultation: Heart: Lungs:
5. Abdomen - Obstetrical Examination:
Inspection: Incisional Scars: Yes/No Over stretching of abdomen: Yes/No
Prominent veins over the abdomen: Yes/No
Palpation: Before 28th week of pregnancy:
Fundal Height:
Head size:
After 28th week of pregnancy: -
Presentation: Position: Lie:
Auscultation: Fetal Heart Rate:
6. Extremities - Inspection: Clubbing of fingers
Pedal Oedema: Varicose veins:
7. Pelvic Examination:
Perineum, Vulva, Vagina, Cervix, Adnexa:
Clinical pelvimetry: Adequate – Yes/No
Presentation:
8. Treatment:
Ante-natal:
1. AYUSH AG tablet – 500 mg. 1 tablet TDS, after food, from 3rd month onwards of
pregnancy up to post delivery – 3 months
Vehicle: Milk or water
Odema during pregnancy
1. AYUSH PG tablet–500mg. 1 tablet BD, after breakfast and lunch, up to 30 days
Vehicle: Milk or water
10. Remarks:
951
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
RCH Proforma - Antenatal Care
FORM-II: CLINICAL ASSESSMENT
(Monthly follow up till 6th month, Fortnightly follow up –7th & 8th months,
weekly follow up 9th month to till term, Oedema – weekly follow-up)
952
VIII.
IX.
X.
XI.
XII.
XIII.
XIV.
XV.
XVI.
XVII.
XVIII.
XIX.
XX.
Associated Symptoms & Signs: (mention ‘Y’ for Yes, ‘N’ for No)
I II III IV V VI VII VIII IX X XI XII XIII XIV XV XVI XVII XVIII
Nausea
Vomiting
Heartburn
Indigestion
Constipation
Giddiness
Vaginal
bleeding
Odema
Varicose
veins
Leg cramps
Tingling &
formication
Insomnia
953
Drug Compliance Chart: 100% 75-99% 50-74% <50%
1.
2.
3.
4.
5.
Complications if any:
Outcome of Pregnancy:
1. Outcome of delivery: (1. Abortion 2. Live birth 3. Stillbirth)
2. Type of delivery (1. Normal vertex 2. Breech 3. Instrumental 4. C.S)
3. Place of delivery (1. Home 2. S.C. 3. PHC/CHC 4. Nursing home 5. Hospital
4. Duration of labour (hrs):
5. Conducted by: (1. Dai 2. ANM/Nurse 3. Doctor 4. Relative 5. Other)
6. Safe Birth Kit used (1. Yes 2. No 3. Do not know)
7. Complication in the mother
(1.None 2. PPH 3. Eclampsia 4. Obstructed Labour 5. Retained Placenta)
8. Did mother require referral to higher health facility (1. Yes 2. No)
If yes, Reason————————————————————————————————
Condition of baby:
9. APGAR Scoring:
S.N Sign 0 Neonate’s 1 Neonate’s 2 Neonate’s
score Score score
1. Respiratory Absent Slow, Strong
effort irregular cry
weak cry
2. Heart rate Absent Slow,<100 > 100
3. Muscle tone Limp Some Active
flexion movement
of limbs
954
4. Reflex Absent Facial Cry
response to grimace
flicking of
foot
5. Color Blue-Pale Body pink, Complete-
Limbs blue ly pink
955
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
RCH Proforma - Antenatal Care
FORM-III: LABORATORY INVESTIGAIONS - PARAMETERS
956
12. PCV (%) __________________________
13. Blood Sugar PP______________________
14. Blood Urea _________________________
15. Serum Creatinine _____________________
16. SGPT _____________________________
17. SGPT _____________________________
18. Serum Bilirubin ______________________
19. USG: ______________________________
20. Urine: Routine: _______________________ Microscopic: __________________________
957
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
To evaluate the efficacy of AYUSH PG TAB in non pathological
mild to moderate pedal edema or generalized edema during pregnancy.
I. BACKGROUND:
Despite of advanced technology, a high number of women continue to die during childbirth,
due to any cause, related to or aggravated by the Pregnancy or its management. Every minute,
the loss of a woman, shatters a family. Woman’s health have been neglected since many decades
due to gender inequality, poverty, illiteracy, working for the survival of mother is a human rights
imperative.
Pregnancy is a dynamic state, lot of physiological changes take place in hemodynamic and
other systems of pregnant woman in order to adopt the increasing demands of the growing fetus.
Ayurvedic classics had prescribed a particular diet and drug schedule for pregnant women.
These regimens support the pregnant women all through the antenatal, Intranatal and postnatal
period. The antenatal care is mainly intended to provide optimum nourishment to mother and
fetus; it prepares the reproductive system to withstand the changes during antenatal and intranatal
periods. It facilitates the metabolism of the growing fetus and prevents the obstetrical
complications.
II AIM:
1. To evaluate the efficacy of AYUSH PG TAB in non pathological mild to
moderate pedal edema or generalized edema during pregnancy.
2. To minimise obstetric complications such as pre-eclampsic problems,
III. Centres of the Study: 3 (three)
IV: Sample size and Methods: 60
Sample size: Total case – 60, (20 each in three centres).
V. Investigational product and doses:
AYUSH – PG tablet – 500mg tab BD, for 30 days in cases of mild to moderate pedal edema
or generalized edema during pregnancy.
Design of study: Open trial single blind.
Vehicle – Milk or water
Follow-up: weekly.
958
VI. CRITERIA OF INCLUSION:
1. Pregnant women with non pathological mild to moderate pedal edema or generalized
edema during pregnancy.
2. Pregnancy not associated with any pre-existing medical illness such as TB, Epilepsy,
Hypertension, Diabetes, Severe anaemia etc
3. Age between 18 and 35 years
4. Pregnancy not associated with any Obstetric complications such as Ante-partum
hemorrhage, Multiple Gestations, Partial Hydatidiform Mole, Pre-eclamptic Toxemia,
Pregnancy Induced Hypertension, Malformations of pelvis, Rh-Incompatibility, Bad
Obstetric History etc.
5. Pregnancy not associated with any Gynecological complications such as Fibroid uterus,
ovarian cyst, cervical carcinoma, Genital prolapse etc.
VII. CRITERIA OF EXCLUSION:
1. Age below 18 and above 35 years
2. Any other type of oedema during Pregnancy associated with pre-existing medical
illness like TB, Epilepsy, Hypertension, Diabetes, Heart disease and severe anemia etc.
3. Grand multi-Para
4. Pregnancy associated with any Gynecological complications such as Fibroid uterus,
ovarian cyst, cervical carcinoma, Genital prolapse etc.
5. Pregnancy associated with any Obstetric complications such as Ante-partum
hemorrhage, Multiple Gestations, Partial Hydatidiform Mole, Pre-eclamptic Toxemia,
Pregnancy Induced Hypertension, Malformations of pelvis, Rh-Incompatibility, Bad
Obstetric History etc.
VIII. CRITERIA OF WITHDRAWAL:
1. 100% non-compliance
2. Irregular follow-ups
3. Pregnant woman developing severe obstetric complications
4. Non-availability of the selected cases
IX. ROUTINE EXAMINATION AND ASSESSMENT:
The full details of History and Physical Examination of the pregnant women will be
recorded as per the Proforma (form I & IA).
959
First visit of the pregnant woman will be considered as the initial assessment (whether it is
I or II trimester). Monthly follow up till 6th month, Fortnightly follow up –7th & 8th months,
weekly follow up 9th month to till term, Oedema – weekly follow-up.
X. PERIOD OF STUDY:
7 months for each case. Total duration will be 6 months (For Ayush PG tablet) to
complete the trial at each centre.
XI. FOLLOW-UP:
To be followed up to delivery
XIII. CRITERIA FOR ASSESSMENT OF RESULTS:
Assessment of outcome of Pregnancy:
1. To assess the outcome of delivery as abortion, live birth and still birth
2. Type of delivery as Normal vertex, Breach, Instrumental or Caesarian section
The outcome of this programme will be considered significant if;
i) The woman passes antenatal period without any major complication
ii) Delivery being normal vaginal delivery
iii) Minimal third stage bleeding with normal expulsion of placenta – uncomplicated third stage
iv) Giving birth to a normal, healthy, live child
XIV. STATISTICAL ANALYSIS:
Data of abortion, live birth, still birth and the type of delivery namely Normal vertex,
Breach, Instrumental and Caesarian will be completed and tabulated and analyzed using
appropriate statistical methods.
XV. TRIAL MONITORING AND DATA ANALYSIS:
The progress of the trial will be monitored by field visit by monitoring unit of CCRAS.
Data analysis will be undertaken at the monitoring unit of CCRAS.
XVI. ETHICAL REVIEW:
Each participating Centres Institutional Ethical Committee (IEC) or Head of the Institution
should give clearance certificate before the trial is initiated.
960
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
Proforma - Antenatal Care
FORM-I: SCREENING PROFORMA
961
pelvis, Rh - Incompatibility, Bad Obstetric History etc.
15. Pregnancy associated with Gynecological complications such as Fibroid uterus, Cervical
carcinoma, Genital prolapse, Ovarian cyst etc.
If ‘Yes’ to the 6-10 and ‘No’ to 11-15 above, recruit the subject for the trial, if recruited, subject
serial No._____________
962
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
FORM-I A: HISTORY PROFORMA
963
MEDICAL HISTORY:
Chronic illness: Allergy:
Surgery: Communicable diseases
FAMILY HISTORY:
1). Type of family: Nuclear No. of persons:
Joint: No. of persons:
2). Diseases: Chronic illness: Hypertension: Diabetes
Genetic disorders: (specify)
Psychiatric disorder:
Other:
3). History of Multiple births, Molar pregnancy, Large baby, Post dated labour etc.
PAST MENSTRUAL HISTORY:
Menarche:
Menstruation - Duration Flow:
- Interval:
MARITAL HISTORY:
Age of marriage: Marital life (in years):
Consanguineous: Yes/No
PERSONAL HISTORY:
Dietary Pattern - Vegetarian: Non-Vegetarian:
Likes:
Habits: Smoking/Drinking/Chewing Pan/Tobacco:
HISTORY OF PREVIOUS PREGNANCY:
S.N Year Full Pre Post Abortion Type of Baby
term term term Delivery Sex Alive Stillborn Weight
964
1). Instrumental delivery
2). IUFD
3). Hemorrhage- Antepartum: Intrapartum:
4). Bad Obstetric History (History of 3 or > abortion or fetal deaths)
5). Neonatal death: Reason:
6). Previous Caesarian Section: Reason:
7). PET / Eclampsia:
8). Ayurveda care taken during previous pregnancies: Y/N
HISTORY OF PRESENT PREGNANCY:
1). Nausea / Vomiting 10). Vaginal bleeding: I TM - II TM - III TM-
2). Heart burn 11). Oedema
3). Indigestion 12). Hb < 8gms %
4). Constipation 13). Heart disease
5). Giddiness 14). Diabetes
6). Hypertension 15). Uterine irritation/contractions
7). Varicose veins 16). Leg cramps
8). Hemorrhoids 17). Insomnia
9). Tingling & formication
MEDICATION:
1). Whether received TT during this pregnancy: No. of doses
2). Whether received IFA, Calcium during this pregnancy
3). Any other medication
CLINICAL EXAMINATION:
General Examination: Blood Pressure: TPR:
1. Height 2. Weight
3. Head & Neck: Eyes: Mouth:
Neck: - Lymph gland
- Thyroid gland
4. Thorax:
965
Inspection: Breast: Nipple condition - Cracks - Depression
Areola condition
Auscultation: Heart: Lungs:
5. Abdomen - Obstetrical Examination:
Inspection: Incisional Scars: Yes/No Over stretching of abdomen: Yes/No
Prominent veins over the abdomen: Yes/No
Palpation: Before 28th week of pregnancy: -
Fundal Height:
Head size:
After 28th week of pregnancy: -
Presentation: Position: Lie:
Auscultation: Fetal Heart Rate:
6. Extremities - Inspection: Clubbing of fingers
Pedal Oedema: Varicose veins:
7. Pelvic Examination:
Perineum, Vulva, Vagina, Cervix, Adnexa:
Clinical pelvimetry: Adequate – Yes/No
Presentation:
8. Treatment:
Ante-natal:
1. AYUSH AG tablet – 500 mg. 1 tablet TDS, after food, from 3rd month onwards of
pregnancy up to post delivery – 3 months
Vehicle: Milk or water
Odema during pregnancy
1. AYUSH PG tablet–500mg. 1 tablet BD, after breakfast and lunch, up to 30 days
Vehicle: Milk or water
10. Remarks:
966
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
RCH Proforma - Antenatal Care
FORM-II: CLINICAL ASSESSMENT
(Monthly follow up till 6th month, Fortnightly follow up –7th & 8th months,
weekly follow up 9th month to till term, Oedema – weekly follow-up)
967
VII.
VIII.
IX.
X.
XI.
XII.
XIII.
XIV.
XV.
XVI.
XVII.
XVIII.
XIX.
XX.
Associated Symptoms & Signs: (mention ‘Y’ for Yes, ‘N’ for No)
I II III IV V VI VII VIII IX X XI XII XIII XIV XV XVI XVII XVIII
Nausea
Vomiting
Heartburn
Indigestion
Constipation
Giddiness
Vaginal
bleeding
Odema
Varicose
veins
Leg cramps
Tingling &
formication
Insomnia
968
Drug Compliance Chart: 100% 75-99% 50-74% <50%
1.
2.
3.
4.
5.
Complications if any:
Outcome of Pregnancy:
1. Outcome of delivery: (1. Abortion 2. Live birth 3. Stillbirth)
2. Type of delivery (1. Normal vertex 2. Breech 3. Instrumental 4. C.S)
3. Place of delivery (1. Home 2. S.C. 3. PHC/CHC 4. Nursing home 5. Hospital
4. Duration of labour (hrs):
5. Conducted by: (1. Dai 2. ANM/Nurse 3. Doctor 4. Relative 5. Other)
6. Safe Birth Kit used (1. Yes 2. No 3. Do not know)
7. Complication in the mother
(1.None 2. PPH 3. Eclampsia 4. Obstructed Labour 5. Retained Placenta)
8. Did mother require referral to higher health facility (1. Yes 2. No)
If yes, Reason————————————————————————————————
Condition of baby:
9. APGAR Scoring:
S.N Sign 0 Neonate’s 1 Neonate’s 2 Neonate’s
score Score score
1. Respiratory Absent Slow, Strong
effort irregular cry
weak cry
2. Heart rate Absent Slow,<100 > 100
3. Muscle tone Limp Some Active
flexion movement
of limbs
969
4. Reflex Absent Facial Cry
response to grimace
flicking of
foot
5. Color Blue-Pale Body pink, Complete-
Limbs blue ly pink
970
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
RCH Proforma - Antenatal Care
FORM-III: LABORATORY INVESTIGAIONS - PARAMETERS
971
12. PCV (%) ______________________
13. Blood Sugar PP_________________
14. Blood Urea ____________________
15. Serum Creatinine _______________
16. SGPT ________________________
17. SGPT ________________________
18. Serum Bilirubin ________________
19. USG: _________________________
20. Urine: Routine: _______________________ Microscopic: ____________________
972
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
“To evaluate the effect of AYUSH B.R. Leham on growth and development, immunity
in infants”
I. BACKGROUND:
Approximately one million newborn deaths could be avoided every year through the
promotion of optimal newborn care practices. To be most effective, these interventions need site-
specific information on existing newborn practices, barriers and facilitating factors for adopting
optimal practices.
While India’s target under the MDG for mortality of children under age 5 is 38 per 1,000
live births, the number of children who die before their fifth birthday stands at 76 at present. Infant
mortality rate in India stands at 57 per 1,000 live births while neonatal mortality rate - deaths in
the first month of life - stands at 43 per 1,000 live births. According to the report, brought out by
the International Partnership for Maternal, Newborn and Child Health (MNCH), an umbrella
organisation comprising about 240 members such as UNICEF, WHO and Save the Children,
India’s average annual rate of reduction of child deaths between 1990 – 2006, has been just
2.6%. If India wants to achieve the agreed targets by 2015, the required rate to reduce child and
maternal mortality will have to be 7.6% from 2007-2015.
Proper neonatal care during immediate neonatal period and infancy will bring down the
Infant and neonatal mortality rate effectively, prevent ailments of childhood and ensure optimum
physical as well as mental growth of the baby. This can be done through package of the services
comprising the nutrition, immunization and periodical health check ups. Ayurveda, the holistic
system of medicine can render the above said package of services to the neonate in a
comprehensive and integrated manner. The neonatal care described in Ayurveda is advanced and
it advocates neutraceutical drugs use. Neutraceutical kinds of Rasayana drugs act as growth
promoters through their multiple actions and can prevent the ailments, which occur during the
neonatal period to infantile period. The present study is under taken to promote the Neonatal and
infantile care as per Ayurveda to ensure optimum growth and development of the child.
II AIM:
1. To Ensure proper growth and development of Neonate.
2. To Enhance immunity
3. To support Physiological functions of baby like digestion, absorption and assimilation
4. To prevent frequent episodes of neonatal and childhood ailments.
III. CENTRES OF THE STUDY: 2
973
IV: SAMPLE SIZE AND METHODS:
Sample size: 100 cases
Treatment: AYUSH– Bal Rakshak Leham – 500 mg, once in a day during first month
increase in first month of treatment followed by increment of 500 mg every month till the
completion of trial period
Duration of ‘Leham’ administration: Six month
Duration of study: 12 months
Design of study: Open trial single blind.
Level of Study: OPD
Follow-up: To be followed up to one year age.
V. CRITERIA OF INCLUSION:
1. Healthy, full term (AGA) baby.
2. Baby born by vaginal spontaneous delivery.
3. Baby has APGAR score in between 8 -10 at one minute.
VI. CRITERIA OF EXCLUSION:
1. Baby has APGAR score less than 8 at one minute.
2. Full Term babies with SGA and LGA.
3. Pre term and post term babies with AGA/SGA/LGA.
4. Baby born by dystocia, delayed labour.
5. Baby with congenital anomalies.
6. Baby with Rh – incompatability.
7. Baby with Pathological neonatal icterus, cyanosis, anemia and other diseases.
8. Baby with birth asphyxia
9. Baby with birth injuries like fracture, dislocation of the joint, paralysis etc.
10. Baby with HIE (Hypoxic ischemic encephalopathy).
11. Baby born to the women suffering with metabolic/hormonal disorders and TORCH
infection.
12. Baby is associated with severe septicaemia, meningitis or any other life threatening disorfer.
974
VII. CRITERIA OF WITHDRAWAL:
1. 100% non-compliance
2. Irregular follow-ups
3. Baby developing any severe systemic diseases during the trial period.
4. Non-availability of the selected cases at due follow ups
VIII. ROUTINE EXAMINATION AND ASSESSMENT:
The full details of ‘History and Physical Examination’ of the baby will be recorded as per
the Proforma (form I & IA) in hard and soft copy at first and subsequently on each visit till the
age of 12 months.
First visit of the baby will be considered as the initial assessment (after the delivery).
XI. PERIOD OF STUDY: 12 months for each case. Total duration will be five years to
complete the trial at each Centre.
X. FOLLOW-UP: To be followed up monthly till 12 months age of the baby.
XI. CRITERIA FOR THE ASSESSMENT OF RESULTS:
Assessment of outcome: Following criteria shall be adopted for the assessment-
1. The growth of children shall be assessed by means of Anthropometrical parameters noted
on the growth chart.
2. Developmental assessment shall be carried out as per the Gesell’s Development Schedules
The outcome of the study will be considered significant if-
i) There is significant reduction or does not develop any severe diseases up to 12 months
period.
ii) There is optimum gain in Anthropometric measurements at the given age.
iii) Reduction in or absence of seasonal disorders.
XII. STATISTICAL ANALYSIS:
Data gathered during the trial period on the preformed format including the Anthropometric
measurements will be analyzed by using appropriate statistical methods.
XIII. TRIAL MONITORING AND DATA ANALYSIS:
The progress of the trial will be monitored by field visit by monitoring unit of CCRAS.
Data analysis will be undertaken at the monitoring unit of CCRAS.
975
XIX. ETHICAL REVIEW:
Each participating Centres Institutional Ethical Committee (IEC) or Head of the Institution
should give clearance certificate before the Project as initiated. Patient’s Information Sheet and
informed consent form should be submitted along with Project proposal for approval by IEC/Head
of the Institution. Both should be maintained in duplicate with one copy given to the patient at the
time of entry to
976
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
FORM-I: SCREENING PROFORMA
977
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
FORM-I A: HISTORY PROFORMA
1. Code no. (of Clinical Trial)
2. Centre: __________________________________________________________________
3. Name of the Subject: ___________________Name of the Mother____________________
4. Date of Birth: Age (in years):
5. Postal Address_____________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
Telephone number: Mobile: Landline:
D.O.R (Date of registration):
SOCIO ECONOMIC BACKGROUND:
1). Education:
Father: 1.Nil 2.Upto Primary 3.Upto middle
4. Upto 10+2 5. College & Above
Mother: 1.Nil 2.Upto Primary 3.Upto middle
4. Upto 10+2 5. College & Above
2). Occupation: Father: Mother:
3). Family Income per month in Rs:
4). Religion: 1.Hindu 2.Muslim 3.Sikh
4.Christian 5.Others
5). Working Status of mother:
1. Not gainfully employed 2. Casual worker
3. Own business 4. Regular salaried job
PRENATAL HISTORY: Gestation ageat first visit (in weeks):
LMP: D/M/Y Gravida: Parity:
EDD: D/M/Y
978
MEDICAL HISTORY OF MOTHER:
Chronic illness: Allergy:
Surgery: Communicable diseases:
PERSONAL HISTORY OF MOTHER:
Dietary Pattern - Vegetarian: Non-Vegetarian:
Likes:
Habits: Smoking/Drinking/Chewing Pan/Tobacco:
979
5. Diabetes
6. Hypertension
HISTORY OF PRESENT LABOUR:
1. Type of labour: Normal/Abnormal (Specify)
2. Duration of labour:
3. Fetal distress: Present / Absent
4. Membranes ruptured: Spontaneously/Artificially…………….. hours before delivery
5. Character of amniotic fluid: Clear/Meconium stained/Foul smelling
Amount: Scanty/Normal/Excessive
6. Placenta and membranes: Healthy/Unhealthy Retroplacental clots Yes /No
7. Cord: Prolapsed/Around neck body
8. Drugs and treatment given ……………………..............……………………………………
BABY:
Date and time of Birth……………………Sex: Male/Female
Condition at birth: Active/Asphyxiated…………………………………….........................…
APGAR Scoring: Score at one minute Score at five minutes
Severe asphyxia
Moderate asphyxia
Mild asphyxia No asphyxia
GENERAL EXAMINATION
Moulding: Normal/Excessive/Nil
Caput: Yes/No Skin…………………………
Eyes…………........….....… Limbs………………....…….
Mouth…………………...... Genitalia………………...…..
Heart……………….....….. Lungs……………….............
Abdomen……………….... Anus………………..............
Other findings…………………………………………………....................
980
ANTHROPOMETRIC MEASUREMENTS
Weight……………
Crown Rump Length……….................. Head Circumference……..……
Mid Arm Circumference………........…. Chest Circumference………….
TREATMENT:
1.AYUSH –Bal Rakshak leham – 500mg once in a day during first month increase 500 mg every
month up to 6 months.
REMARKS:
981
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
FORM-II: CLINICAL ASSESSMENT
(Monthly follow up till 12th month)
982
GROWTH CHART OF BABY (ANTHROPOMETRIC ASSESSMENT)
983
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
FORM-III: LABORATORY INVESTIGAIONS - PARAMETERS
984
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
TO EVALUATE THE EFFICACY OF AYUSH PK-AVALEHA IN PREVENTING
POSTPARTUM COMPLICATIONS AND PUERPERIAL CARE.
INTRODUCTION:
Puerperium begins as soon as the Placenta is expelled and lasts for approximately 6
weeks. During this phase woman’s body tissues, especially pelvic organs revert back
approximately to the pre pregnant state both anatomically and physiologically by the process called
involution. In the immediate Postpartum, apart from involution, general physiological changes such
as raise in the pulse rate, reactionary rise in temperature may be there. Bladder becomes
oedematous with hyperaemic and woman becomes relatively insensitive to the raise intra vesicle
pressure due to the trauma sustained to the nerve plexus during delivery, the bladder may be over
distended without any desire to pass urine. Stagnation of the urine along with a devitalized bladder
wall contributes to the urinary tract infection in puerperium.
Treatment:
1. Ayush PK Avaleha: 5 gm twice daily with milk or water for 45 days after delivery.
Vehicle – Milk or water
AIMS
1. To support health status of mother during puerperium
2. To reduce perinatal mortality and morbidity
3. To prevent complications of Postpartum
4. To ensure early sub involutions of uterus.
V. CRITERIA OF INCLUSION:
1. Age between 20 – 35 years
2. Puerperium without any severe complications like Post partum haemorrhage,
Sub involution of uterus etc.
3. Normally delivered /Caesarian delivery
4. Not associated with postnatal eclampsia, Puerperal psychosis, Post-gestational diabetes etc.
985
VI. CRITERIA OF EXCLUSION:
1. Puerperium associated with severe Postpartum haemorrhage
2. Cases with acute puerperal inversion of Uterus
3. Cases associated with Postnatal eclampsia, Puerperal psychosis, Post gestational diabetes etc.
4. Puerperal woman aged below 15 and above 35 years of age.
VII. CRITERIA OF WITHDRAWAL:
1. Patients not complying with treatment
2. Development of complications like haemorrhage, convulsion etc.
3. Patients left the study in between
VIII. ROUTINE EXAMINATION AND ASSESSMENT:
The full details of history and physical examinations of the patients will be recorded as per
the Proforma (Forms 1& 1A) Clinical assessment will be done before drug administration on
1st , 2nd , 3rd , 4th ,5th ,6th ,7th , 15th ,30th 45th day during drug treatment period ,30th ,60th
,90th day during follow-up (Form-II). Laboratory investigations carried out according to Form-III.
IX. PERIOD OF STUDY:
3 months for each case. Total duration will be 1 year to complete the trial at each centre.
X. FOLLOW –UP: The follow-ups will be carried out after 30th, 60th, and 90th day.
XI. CRITERIA FOR ASSESSMENT OF RESUTS:
Completion of puerperium without any complications, early involution of Uterus, proper
onset and maintenance of lactation, improvement in general health status of mother will be
considered as significant improvement.
XII. STATISTICAL ANALYSIS:
Data on involution of Uterus, prevention of the complications of puerperium, lactation
maintenance will be tabulated and analysed using appropriate statistical methods.
XIII. TRAIL MONITORING AND DATA ANALYSIS:
The progress of the trial will be monitored by field visits by monitoring unit of CCRAS.
Data analysis will be undertaken at monitoring unit of CCRAS.
XIX. ETHICAL REVIEW:
Each participating Centres Institutional Ethical Committee (IEC) or Head of Institution
should give clearance certificate before the Project is initiated. Patients information sheet and
informed consent form should be submitted in duplicate with one copy given to the patient at the
time of entry to the trial.
986
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
FORM-I: SCREENING PROFORMA
987
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
FORM-I A: HISTORY PROFORMA
1. Code no. (of Clinical Trial)
2. Centre: __________________________________________________________________
3. Name of the subject: _______________________________________________________
4. Date of Birth: Age (in years):
5. Postal Address______________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
Telephone number: Mobile: Landline:
D.O. A: D.O.D:
SOCIO ECONOMIC BACKGROUND:
1). Education:
Husband:
1. Nil 2. Upto Primary 3.Upto middle
4. Upto 10+2 5. College & Above
Wife:
1.Nil 2.Upto Primary 3.Upto middle
4. Upto 10+2 5. College & Above
2). Occupation: Husband: Wife:
3). Family Income per month in Rs:
4). Religion: 1.Hindu 2.Muslim 3.Sikh 4.Cristian 5.Others
5). Working Status: 1. Not gainfully employed 2. Casual worker
3. Own business 4. Regular salaried job
PRENATAL HISTORY: Gravida: Parity:
LMP: D/M/Y
EDD: D/M/Y
988
MEDICAL HISTORY:
Chronic illness: Allergy:
Surgery: Communicable diseases
FAMILY HISTORY:
1). Type of family: Nuclear No. of persons:
Joint: No. of persons:
2). Diseases: Chronic illness: Hypertension: Diabetes
Genetic disorders: (specify)
Psychiatric disorder:
Other:
3). History of Multiple births:
PAST MENSTRUAL HISTORY:
Menarche:
Menstruation - Duration Flow:
- Interval:
MARITAL HISTORY:
Age of marriage: Marital life (in years):
Consanguineous: Yes/No
PERSONAL HISTORY:
Dietary Pattern - Vegetarian: Non-Vegetarian:
Likes:
Habits: Smoking/Drinking/Chewing Pan/Tobacco:
HISTORY OF PREVIOUS PREGNANCY:
S.N Year Full Pre Post Abortion Type of Baby
term term term Delivery Sex Alive Stillborn Weight
989
1). Instrumental delivery
2). IUFD
3). Hemorrhage- Antepartum: Intrapartum:
4). Bad Obstetric History (History of 3 or > abortion or fetal deaths)
5). Neonatal death – Reason:
6). Previous Caesarian Section - Reason:
7). PET Eclampsia:
LABOUR HISTORY: Date Time:
Type of Delivery:
Duration of Labour: First stage: Hrs. mnts
Second stage: Hrs mnts
Third stage: Hrs mnts
Condition of Baby: Active / Asphyxiated / still birth / macerated
APGAR Score: __________________
Treatment at Birth: ________________
Delivery of placenta & membranes:
Delivered Time:___________________
Spontaneous / Helped out / Manually Removed:
Type of Placenta:
Placenta & Membranes: Complete / Incomplete:
Weight: __________ Cord length: ___________ Cord insertion: ______________
Any abnormality:
Total blood loss: ml
Perineum: Intact / Episiotomy:
Laceration
Medicines given:
Condition of mother following delivery:
990
Pulse: B.P Temp.
Uterus: Hard / Soft
Vaginal bleeding:
POSTNATAL HISTORY:
Fever: Condition of Breast:
Excessive vaginal bleeding: Onset of Milk
Breast fullness with fever: Mental condition:
Burning on passing urine: Foul smelling vaginal discharge:
Puerperal Psychosis:
TREATMENT:
Mother:
1. Ayush - PK Avaleha : 5 gm twice daily with milk or water for 45 days after delivery
- Vehicle: Milk or water
991
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
FORM-II: CLINICAL ASSESMENT
1. Code no. (of Clinical Trial):
2. Centre: ____________________________________________________________________
3. Name of the subject: ________________________________________________________
4. Date of Birth: Age (in years):
5. Postal Address_____________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
Follow-up chart of puerperium:
F C
104.9 40.5 20
104.0 40 17.5
103.1 39.5 15
102.2 39 12.5
101.3 38.5 10
100.4 38 7.5
99.5 37.5 5
98.6 37 2.5
97.7 36.5
96.8 36
95.9 35.5
992
Pulse M
E
Respir M
ation E
B.P M
E
Lochia
Urine
Motion
Weight
Episiotomy wound
a). Discharges-
Yes/No
(Blood/Pus/Serous)
b).Colour of the
wound –
Pinkish/other
c). granulation
formed /not
d). condition of
the wound –
healthy/not healthy
Lactation
993
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
FORM-III: LABORATORY INVESTIGATIONS - PARAMETERS
994
13. Blood Sugar PP_________________
14. Blood Urea ____________________
15. Serum Creatinine _______________
16. SGPT ________________________
17. SGPT ________________________
18. Serum Bilirubin ________________
19. USG: _________________________
20. Urine: Routine: _______________________ Microscopic: ____________________
995
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
TO EVALUATE THE EFFICACY OF AYUSH SS-GRANULES TO ENSURE
QUALITY & QUANTITY OF BREAST MILK
I INTRODUCTION
There will be increased thirst in early puerperium is due to loss of fluid during labour in the
lochia, diuresis and perspiration. Slight intestinal paresis leads to constipation. Colostrum secretion
from breasts becomes more abundant.
Post-natal care mainly aims at management of postnatal ailments and supporting involution
of genital organs, onset and maintenance of lactation, betterment of general health status of mother.
II. AIMS:
1. To ensure proper lactation and quality, quantity of breast milk
III. Centres of the Study: 03 (Three)
IV. Sample size and Methods:
Sample size: 60 cases
Ayush SS granules: 10gm. BD, after breakfast and at bedtime through out lactation period.
Vehicle: Milk or water
Duration: 3 months
Design of the Study: Open trial
The progress of the trial will be monitored by field visits by monitoring unit of CCRAS. Data
analysis will be undertaken at monitoring unit of CCRAS.
XIX. ETHICAL REVIEW:
Each participating Centres Institutional Ethical Committee (IEC) or Head of Institution
should give clearance certificate before the Project is initiated. Patients information sheet and
informed consent form should be submitted in duplicate with one copy given to the patient at the
time of entry to the trial.
Efficacy parameters: Test for quality & quantity of milk-
Parameters of Assessment:
996
1. Improvement in Quantity of milk
2. Assessment of pre and post treatment serum prolactin levels
3. Assessment of weight gain by child
4. Analysis of breast-milk samples [Proteins, Lactose (Carbohydrate), Fat, Minerals
(Calcium, Phosphorous)]
5. Global Investigator’s assessment
6. Global Subject’s assessment
7. Safety Evaluation
997
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
FORM-I: SCREENING PROFORMA
998
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
FORM-I A: HISTORY PROFORMA
999
MEDICAL HISTORY:
Chronic illness: Allergy:
Surgery: Communicable diseases
FAMILY HISTORY:
1). Type of family: Nuclear No. of persons:
Joint: No. of persons:
2). Diseases: Chronic illness: Hypertension: Diabetes
Genetic disorders: (specify)
Psychiatric disorder:
Other:
3). History of Multiple births:
PAST MENSTRUAL HISTORY:
Menarche:
Menstruation - Duration Flow:
- Interval:
MARITAL HISTORY:
Age of marriage: Marital life (in years):
Consanguineous: Yes/No
PERSONAL HISTORY:
Dietary Pattern - Vegetarian: Non-Vegetarian:
Likes:
Habits: Smoking/Drinking/Chewing Pan/Tobacco:
HISTORY OF PREVIOUS PREGNANCY:
S.N Year Full Pre Post Abortion Type of Baby
term term term Delivery Sex Alive Stillborn Weight
1000
1). Instrumental delivery
2). IUFD
3). Hemorrhage- Antepartum: Intrapartum:
4). Bad Obstetric History (History of 3 or > abortion or fetal deaths)
5). Neonatal death – Reason:
6). Previous Caesarian Section - Reason:
7). PET Eclampsia:
LABOUR HISTORY: Date Time:
Type of Delivery:
Duration of Labour: First stage: Hrs. mnts
Second stage Hrs mnts
Third stage Hrs mnts
Condition of Baby: Active / Asphyxiated / still birth / macerated
APGAR Score:
Treatment at Birth:
Delivery of placenta & membranes:
Delivered Time:
Spontaneous / Helped out / Manually Removed:
Type of Placenta:
Placenta & Membranes: Complete / Incomplete:
Weight: Cord length: Cord insertion:
Any abnormality:
Total blood loss: ml
Perineum: Intact / Episiotomy:
Laceration
Medicines given:
1001
Condition of mother following delivery:
Pulse: B.P Temp.
Uterus: Hard / Soft
Vaginal bleeding:
POSTNATAL HISTORY:
Fever: Condition of Breast:
Excessive vaginal bleeding: Onset of Milk
Breast fullness with fever: Mental condition:
Burning on passing urine: Foul smelling vaginal discharge:
Puerperal Psychosis:
TREATMENT:
AYUSH SS granules: 10gm. BD, after breakfast and at bedtime through out lactation period.
Vehicle: Milk or water
1002
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
FORM-II: CLINICAL ASSESMENT
1. Code no. (of Clinical Trial):
2. Centre: ____________________________________________________________________
3. Name of the subject: _________________________________________________________
4. Date of Birth: Age (in years):
5. Postal Address______________________________________________________________
____________________________________________________________________________
____________________________________________________________________________
Efficacy parameters: Test for quality & quantity of milk
Parameters of Assessment:
1. Improvement in Quantity of milk
2. Assessment of pre and post treatment serum prolactin levels
3. Assessment of weight gain by child
4. Analysis of breast-milk samples [Proteins, Lactose (Carbohydrate), Fat, Minerals (Calcium,
Phosphorous)]
5. Global Investigator’s assessment
6. Global Subject’s assessment
7. Safety Evaluation
1003
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
FORM-III: LABORATORY INVESTIGATIONS - PARAMETERS
1004
11. Fibrinogen time ________________
12. PCV (%) ______________________
13. Blood Sugar PP_________________
14. Blood Urea ____________________
15. Serum Creatinine _______________
16. SGPT ________________________
17. SGPT ________________________
18. Serum Bilirubin ________________
20. Urine: Routine: _______________________ Microscopic: ____________________
21. Analysis of breast-milk samples [Proteins, Lactose (Carbohydrate), Fat, Minerals (Calcium,
Phosphorous)]
1005
BLANK
1006
CLINICAL SAFETY OF SOME
AYURVEDIC AND SIDDHA DRUGS
SECTION - XVIII
1007
Blank
1008
OPEN OBSERVATIONAL STUDY ON CLINICAL
SAFETY OF SELECTED AYURVEDIC AND SIDDHA
HERBOMINERAL AND METALLIC PREPARATIONS
1009
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1010
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
OPEN OBSERVATIONAL STUDY ON CLINICAL SAFETY OF SELECTED
(RASA MANIKYA RASA) AYURVEDIC AND SIDDHA HERBOMINERAL AND
METALLIC PREPARATIONS.
I. BACKGROUND
The use of metals in therapeutic drugs has become increasingly important over the last
couple of decades; Ayurveda recognizes their use long before that. Rasashastra, one among the
subspecialties of Ayurvedic Pharmaceuticals and Siddha classics have specified therapeutic use of
metals and minerals in the form of Bhasmas and Rasakalpas. As these drugs required in lesser
doses, causes no distaste unlike herbal drugs and faster in action, these practices became popular
and widely accepted and safely used since long.1
Heavy metals are chemical elements with a specific gravity that is at least 5 times the
specific gravity of water. There are 35 metals that concern us because of occupational or
residential exposure; 23 of these are the heavy elements or “heavy metals”: antimony, arsenic,
bismuth, cadmium, cerium, chromium, cobalt, copper, gallium, gold, iron, lead, manganese, mercury,
nickel, platinum, silver, tellurium, thallium, tin, uranium, vanadium, and zinc (Glanze 1996).
Interestingly, small amounts of these elements are common in our environment and diet and are
actually necessary for good health, but inappropriate dosage forms of any of them may cause
acute or chronic toxicity (poisoning).
Some well-known toxic metallic elements with a specific gravity that is 5 or more times
that of water are Arsenic, 5.7; Cadmium, 8.65;Iron, 7.9;Lead, 11.34; and Mercury, 13.546 (Lide
1992).2
Articles ( JAMA, Dec.15, 2004, Vol.292, No.23) published in some journals have
mentioned about the toxicity, presence of heavy metal contents of certain Ayurvedic Classical/
Proprietary preparations which is creating misconceptions among scientific communities and general
public regarding the safety of Ayurvedic/Siddha Rasa Kalpas and Bhasmas.
References
1. RasaRatna Samuchchaya,chapter 28/1.
2. http://www.lef.org/protocols/: Heavy Metal Toxicity
3. Rasa Ratna Samuchchaya,chapter 5/11,20,30,147.
1011
The classics of Ayurvedic Rasashastra and siddha system have specified different methods
of preparation and operational procedures since from the collection of raw drugs their purification,
processing, method of use, dosage forms etc. The raw drugs and finished products, if not
processed and preserved as per the classical literature specified, they may lead to improper
finished product with contaminants and may lead to toxic symptoms3. Thus this project is
undertaken to assess the heavy metal toxicity in patients receiving Ayurvedic /siddha preparations.
II. OBJECTIVE:
Observe the clinical/biochemical changes in subjects receiving Rasa Manikya Rasa, an
Ayurvedic Herbomineral / Metallic preparations for ensuring Clinical safety.
III. CENTRE:
Identified CCRAS Institutes.
IV. SAMPLE SIZE AND METHODS:
Sample size : 15 subjects per centre
Type of Study : Open
Level of Study : OPD
Period of Treatment : 15 days
Period of Study : 6 months
Details of treatment schedule
a) Drug: Rasa Manikya Rasa
b) Indicated conditions: Skin disorders, Dermatitis, Eczema etc.
c) Dosage schedule and duration: 60 mg BD for 15 days
d) Combinations with the main drug if any: Rasa Manikya Rasa 60 mg. in 2 gms. of
Chopachini Churna.
e) Anupana [Vehicle]: Lukewarm water
V. CRITERIA FOR INCLUSION:
1. Patients above 20 years and below 60 years of age.
2. Biochemical investigations for heavy metals at 0 day of assessment within the range.
3. Clinically diagnosed cases of Skin disorders, Dermatitis, Eczema etc.
1012
VI. CRITERIA FOR EXCLUSION:
1. Serum metallic levels of any of the metals exceeding permissible range at day 0 of
assessment
2. Age below 20 years & above 60 years
3. Known renal or Hepatic Pathology (Confirm by Clinical/Biochemical parameters)
4. Chronic Industrial Exposure
5. Patient receiving any other mineral preparation other than trial drug.
6. Major neuro-Psychiatric abnormalities
7. Chronic Smokers/Tobacco consumers
VII. CRITERIA FOR WITHDRAWAL:
During the course of the trial treatment, if any serious condition or any serious adverse
events which requires urgent treatment or if patients himself want to withdraw from the study, such
subjects may be withdrawn from the trial.
VIII. ROUTINE EXAMINATION AND ASSESSMENT:
Screening of the patient as per case record form - I. The full details of history and
physical examination of the subjects will be recorded as per case report forms (Case report form
II). Clinical and physiological assessment (Case report form -III) and laboratory investigations
(Case report form -IV) will be done before treatment, at 0 day, 7th & 15thdays.
IX. STATISTICAL ANALYSIS
Data on clinical symptoms and objective tests before and after the treatment will be
tabulated and analyzed using appropriate statistical tools. The data generated at the Institute on the
trial drug will have to be communicated to the Statistical Officer of CCRAS from time to time
through e-mail.
X. CRITERIA FOR ASSESSMENT OF OUTCOME OF STUDY
The assessment of progress & outcome of the study are assessed on the basis of clinical
and biochemical investigations.
XI. TRIAL MONITORING AND DATA ANALYSES
The Statistical Section, CCRAS, Hqrs, New Delhi will undertake the monitoring of
progress of the trial and data analysis.
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XII. ETHICAL REVIEW
A. Ethical Committee (IEC): The proposal will be placed before Ethical Committee (IEC)
of trial center for getting clearance certificate before the project is initiated. Patient’s
information sheet and informed consent form will be submitted along with project proposal
for approval by EC. Both will be maintained in duplicate with one copy given to the
patient at the time of entry to the trial.
B. Data and safety monitoring board: A Data and safety monitoring board (DSMB) at
Hqrs. will carefully monitor the data and side effects during the period of study and put in
a place where by prompt reporting of adverse events occur. The data will be reviewed as
every 20 participants entered the study and administered the trial drugs. The research team
will report immediately to the PI and Data Monitoring Board if, any life threatening
conditions whether they are perceived to be study related or not. The Board decides
whether the adverse effects warrant discontinuation of the study protocol. Protocols will be
written and approved for the treatment of study related adverse events.
XIII. TRAVELLING EXPENSES
A consolidated amount of Rs.100/- per visit 0 day, 7th & 15thdays (Total Rs.300/-) will
be paid to the patient at the end of the study.
XIV. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
Short-term two-day training will be provided to the Investigators and Laboratory
personnel involved in the multicentric trial at CCRAS Hqrs. and Central Research Institute (Ay.),
New Delhi. The investigators and technicians will be detailed about the clinical trial conduct and
laboratory procedures in order to maintain the uniformity.
XV. LABORATORY INVESTIGATIONS
The Laboratory Investigations (Pathological / Biochemical, Radiological / Sonography etc.)
which are not available at research Institutes will be referred to any reputed/Government Institutes
under intimation to this Council following codal formalities.
1014
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
WRITTEN INFORMED CONSENT FORM
CERTIFICATE BY INVESTIGATOR
I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature of the Investigator: ___________
Name: ____________________________
CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending physician, the purpose of the trial
and the nature of drug treatment and follow-up, including the laboratory investigations to be
performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so.
I, exercising my free power of choice, hereby give my consent to be included as a subject
in the clinical trial on “Open Observational Study on Clinical Safety of Selected (Rasa
Manikya Rasa) Ayurvedic and Siddha Herbomineral and Metallic Preparations.”
Relationship ___________________________________
1015
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
OPEN OBSERVATIONAL STUDY ON CLINICAL SAFETY OF SELECTED
(RASA MANIKYA RASA) AYURVEDIC AND SIDDHA HERBOMINERAL AND
METALLIC PREPARATIONS.
PATIENT INFORMATION SHEET
1016
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
OPEN OBSERVATIONAL STUDY ON CLINICAL SAFETY OF SELECTED
(RASA MANIKYA RASA) AYURVEDIC AND SIDDHA HERBOMINERAL AND
METALLIC PREPARATIONS.
CASE REPORT FORM I - SCREENING
BEFORE TREATMENT
(Enter a () in the appropriate box)
1. Centre: ………………..……….
6. Address Permanent postal address with phone number & email if any.
..............................................................................................................................
..............................................................................................................................
1017
7. Chronic Industrial Exposure
A patient is eligible for admission to the trial,only if sl. No.1 - 3 are “yes” & if the sl.
No. 4-10 are “no”.
1018
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
OPEN OBSERVATIONAL STUDY ON CLINICAL SAFETY OF SELECTED
(RASA MANIKYA RASA) AYURVEDIC AND SIDDHA HERBOMINERAL AND
METALLIC PREPARATIONS.
CASE REPORT FORM II – HISTORY
1. Centre: ………………..……….
7. Address Permanent postal address with phone nu,ber & email if any.
Graduate 4 PG 5
Less than Rs. 60,000/- (1) More than Rs. 60,000/- (2)
10. Occupation:
No __________
Was there any significant exposure to dust, chemicals smoke or heavy metal
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No __________
Dosage) 4. —————————————————————
5. —————————————————————
Yes-1 No-2
If yes, details…………………………………………….....................................................
2. Previous episode
3. Duration of disease
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13. Personal History:
Tobacco chewing
Betel chewing
Prakriti
Sama 7
15. DIAGNOSIS:
OTHER SPECIFIC SYMPTOMS IF ANY WITH DURATION (0, 7th & 15thday)
2. Cough (Hg)
1021
7. Thirst (Pb)
1022
30. Emotional instability/Mood swings
(Hg, Pb)
{ Weight (kg.)
B.M.I. ———————
Height (meters)2 } ________________
Systolic ________________
Diastolic ________________
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Absent(0) Present (1)
Pallor
Lymphadenopathy
Cyanosis (As)
Clubbing nails
Edema
If present, specify
Erythroderma (As)
Hyperkeratosis (As)
Hyperpigmentation (As)
CVS
If abnormal, details________________________________________________________
CNS
Respiratory system
1024
Digestive system
Urogenital system
1025
OPEN OBSERVATIONAL STUDY ON CLINICAL SAFETY OF SELECTED
(RASA MANIKYA RASA) AYURVEDIC AND SIDDHA HERBOMINERAL AND
METALLIC PREPARATIONS.
CASE REPORT FORM III – CLINICAL AND PHYSIOLOGICAL ASSESSMENT
(0, 7th & 15th day)
1. Centre: ………………..……….
..............................................................................................................................
Email ID ..............................................................................................................
2. Cough (Hg)
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6. Excessive Salivation (Cd)
7. Thirst (Pb)
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29. Anxiety (Hg)
3.
{
Weight (kg.)
B.M.I. ———————
Height (meters)2 } ________________
7. Systolic ________________
8. Diastolic ________________
10. Pallor
11. Lymphadenopathy
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13. Clubbing nails
14. Edema
CVS
If abnormal, details________________________________________________________
CNS
Respiratory system
Digestive system
Urogenital system
*Note: Separate sheet of this form should be used for separate visits i.e 3 sheets for
3 visits.
1029
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
OPEN OBSERVATIONAL STUDY ON CLINICAL SAFETY OF SELECTED
(RASA MANIKYA RASA) AYURVEDIC AND SIDDHA HERBOMINERAL AND
METALLIC PREPARATIONS.
CASE REPORT FORM IV – LABORATORY INVESTIGATIONS
(0, 7th & 15thday)
1. Centre: ………………..……….
Urine Examination
8. Routine____________ Microscopic___________
Pb___________
Cd___________
Hg___________
Haematological Investigations
Pb ___________
Cd ___________
Hg ___________
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11. Hb (g/dl) _______________________________
DLC
Blood Sugar
27. S.Bilirubin(mg./dL)
a. Total __________________
b. Direct __________________
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c. Indirect __________________
_____________________________________________
Place:_____________
Note:
*Note: Separate sheet of this form should be used for separate visits i.e. 3sheets for 3
visits.
1032
ANNEXURE-I
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Children and adults < 10 ug/dl hour) 0 - 31 ug/d
Exposed: Children (0-6 years) Lead per gm of
> 10 ug/dl Creatinine
Adults (occupational exposure) No reference
OSHA action level 40ug/dl interval (ug/g CRT)
BEI (Biological Exposure 30
ug/dl
Index) (sampling time not
critical)
BAT (Biological Tolerance 70
ug/dl
Value) (sampling time not
critical)
Toxic: Children (0-6 years) >
70 ug/dl
Adults > 80 ug/dl
3. Cadmium 0.0 - 5.0 mcg/L Cadmium, Urine Urine (24 hr.)
0.0-2.6 ug/L CBC
Cadmium, Urine Hair Fingernail
(24-hour) 0.0-3.3
ug/d
Cadmium per
gram of creatinine
0.0-3.0 ug/g crt
4. Mercury Mercury (blood): (Mercury Mercury, Urine = Urine (24hr.)
measured as total mercury 0-10 ug/L Scalp hair
(inorganic, organic, and metallic). Mercury, Urine
Reporting Limit: 5 ng/ml (24-Hour) = 0-15
Reference Range: Up to 15 ng/ ug/d
ml Mercury per gram
Normal (unexposed population): of creatinine = No
less than 8 ng/ml reference interval
Exposed: (ug/g CRT)
BEI (Biological Exposure
Index): 15 ng/ml (total
inorganic) (end of shift, end of
workweek)
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BAT (Biological Tolerance
Value) 50 ng/ml (metallic and
inorganic)
BAT (Biological Tolerance
Value): 100 ng/ml (organic)
References
1. Harrison’s Principle of Internal Medicine 15th Edition page No.2590 –2595
2. http://www.medicine.uiowa.edu/Path_Handbook/indices/B.html
1035
ANNEXURE-II
LEAD
Lead is number 2 on the ATSDR’s “Top 20 List.”
Source: Every year, industry produces about 2.5 million tons of lead throughout the world. Most
of this lead is used for batteries. The remainder is used for cable coverings, plumbing, ammunition,
and fuel additives. Other uses are as paint pigments and in PVC plastics, x-ray shielding, crystal
glass production, pencils, and pesticides.
The inorganic forms of lead are absorbed through ingestion or inhalation, whereas organic lead salts
are absorbed through the skin. Only about 10% of an ingested dose is absorbed in adults, but the
absorbed percentage may be much greater in children. Lead absorption is enhanced by
deficiencies of iron, calcium, and zinc.
Targeted organs: Bones, Brain, Blood, kidneys, and thyroid gland (International Occupational
Safety and Health Information Centre 1999; ATSDR ToxFAQs for Lead).
Half Life: Some authorities list the half-life of lead in the bone as long as 30 years, while others
estimate the lead half-life in bone to be 105 days. Generally, excretion of lead is slow, with an
estimated biologic half-life in soft tissues of 24-40 days. The remainder of the stored lead is found
in soft tissue, notably the kidney and brain.
Excretion: The primary route of excretion is through feces (80-90%). To a lesser extent, lead is
excreted in urine (10%). Lead passes the placental barrier and is found in breast milk.
Clinical Features – A patient with lead poisoning may have a combination of symptoms - or no
symptoms at all until the condition has progressed.
Acute Poisoning
Alimentary System - Thirst
Metallic taste in mouth
Nausea
Colic (Abdominal pain)
Diarrhoea
Loss of appetite (Anorexia)
CNS Parasthesia (numbness) Hallucination
Muscle pain Vertigo
Fatigue Lethargy
Convulsions Ataxia
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Slurred speech Sleeplessness
Loss of consciousness
CVS Hypotension / Hypertension
Circulatory collapse
Blood Pallor (Severe Anemia – acute hemolytic crisis)
Renal System Oliguria
Chronic Poisoning
Births defects Shaky hand Numbness
Mental Retardation Muscular weakness lack of concentration
Autism Paralysis (Beginning in fore arms) Psychosis
Allergies Arthritis Colic
Dyslexia Hyper activity Weight loss
Mood swings Nausea
Leadline in gingival
Seizures
Chronic subclinical exposure to lead is associated
Interstitial nephritis,
Tubular damage
Hyperuricaemia
Oliguria (decline in GFR)
Chronic Renal Failure.
Blood lead levels in the range of 0.34 – 1.7 μmol/lit are associated with
• Increase in blood Pressure
• Decrease in creatinine clearance
• Decrements in cognitive performance
Laboratory Investigation -
1. Blood Test
(i) Blood Lead levels (N) blood level of lead < 1.9 μmol/L (40 μg/dl)
In children > 10 mcg/dl;
In Adults > 40 μ/dl are considered to be of concern
1037
(ii) Complete Blood Count (CBC) – (Normochromic, Normocytic anemia with
Basophilic stipplings on red cells in lead poisoning)
(iii) Serum Creatinine level (Elevated in chronic lead poisoning)
2. Long bone X-ray (in Children) (May reveal bands that indicate the failure of the bone to
rebuild)
3. Measurement of lead in teeth
4. Levels of lead in Urine [ Random urine < 150 μg/g creatinine (Not provoked with a
chelator) ]
5. Levels of lead in Faeces
6. Nerve Conduction Time (To know nerve induced peripheral demyelination)
7. Bone Lead Levels- k- ray-Flourescence
1038
ARSENIC
ANNEXURE-III
Arsenic is the most common cause of acute heavy metal poisoning in adults and is number
1 on the ATSDR’s “Top 20 List.
Sources: Sources of arsenic include
• Pesticides
• Herbicides
• Fungicides
• Wood preservatives
• Ceramic enamels
• Paints
• Tobacco (There may be as much as 6 micrograms per pack)
• Burning of Fossil fuels as arsenic is a contaminant
Occupational exposure can occur in
• The Smelting Industry (arsenic is a by –product of ores containing lead,gold,zinc,cobalt and
nickel)
• The microelectronics Industry
• Coal Power Plants
• Jobs involving the manufacturing of glass and fireworks
• Jobs with contact with pesticides
• Jobs with contact with wood treated with arsenic as a preservative
Absorption – Absorbed through skin, lungs and GIT
Targeted Organ: Target organs are the blood, kidneys, and central nervous, digestive, and skin
systems.
After absorption of inorganic arsenic, the compound accumulates in the liver, spleen,
kidneys, lungs and gastrointestinal tract. It is then rapidly cleared from these tissues but it leaves
a residue in Keratin rich tissues such as skin, hair and nails.
Metabolism Inorganic compounds are absorbed more readily than organic 80% of this is
ingested through GIT.
Blood 24 hour liver, kidney, lung and spleen
2 weeks skin, hair & bone.
1039
Inorganic salts in - leukocytes
1040
Hyperkeratosis
Hyperpigmentation
Exfoliative Dermatitis
Aldrich Mees lines (Transverse white striae on the fingernails)
Mucous Membrane
• Laryngitis
• Tracheitis
• Bronchitis
CNS • Polyneuritis (sensory & Motor)
• Basal cell carcinomas
• Squamous cell carcinomas
Other effects • Capillary injury
Necrosis of stomach, small bowel, vascular & degenerative changes in liver
& kidney
Laboratory Investigations-
Arsenic levels can be measured in blood, urine, hair and fingernails. Urine tests are most reliable
1. X-ray abdomen - (As is radio opaque and is seen on x-ray of abdomen).
2. ECG- (QRS complex broadening, QT prolongation, ST segment depression, T wave
flattening & multifocal ventricular tachycardia)
3. LFT (abnormal)
4. Hb (anaemia)
5. Leukopenia/ Leukocytosis
6. Protein urea
7. Hematuria
8. Cellular casts in the urine
9. Urine Arsenic levels (normally less than 67 nmol 5 μg/d)
10. May also be detected in hairs & nails for months following exposure.
1041
ANNEXURE-IV
CADMIUM
Cadmium is a byproduct of the mining and smelting of lead and zinc and is number 7 on
ATSDR’s “Top 20 list.”
(Absorbed Cd is mostly concentrated in liver and kidneys)
Sources – Cadmium has a wide variety of sources in the environment and from industry. One
source is from ingestion of grown foodstuffs, especially grain and leafy vegetables, which readily
absorb cadmium from the soil. The cadmium may occur naturally or as a contaminant and the
contaminants include sewage, sludge fertilizers, polluted ground water and mining effluents.
Cadmium is also a constituent of alloys, pigments, batteries, metal coatings for example protective
coating on steel, plastics and fertilizers. Occupational exposure may occur from the manufacture of
these products and from welding, and smelting of lead, zinc and copper as these occur in mixed
ores with cadmium. Cadmium is also found in Cigarette fumes and fumes from vehicles.
Absorption: Inhalation accounts for 15-50% of absorption through the respiratory system; 2-7%
of ingested cadmium is absorbed in the gastrointestinal system.
Target organs - Target organs are the liver, placenta, kidneys, lungs, brain, and bones (Roberts
1999; ATSDR ToxFAQs for Cadmium).
Clinical Toxicology – (4-24 h)
Acute - High dose Cd inhalation can cause severe respiratory irritation.
Pleuritic chest pain
Dysponea
Cyanosis
Fever
Tachycardia
Nauses
Pulmonary edema (non cardiogenic)
COPD
Renal Disease
Fragile bones
Emphysema
1042
Through Ingestion (Acute)
Nauses
Vomiting
Salivation
Abdominal cramps
Diarrhoea
Chronic
Anosmia - Alopecia
Yellowing of the teeth - Anaemia
Emphysema - arthritis
Minor changes in the liver function - learning disorders
Micorocytic hypochronic anemia
(unresponsive to iron therapy) - migraines
Renal tubular dysfunction
(Proteinuria & increased excretion of B2 microglobulin) - growth impairment
Osteomalacia (bone lesions & Pseudofractures)
Osteoporosis, loss of taste & smell poor appetite
Lab. Findings.
1. Blood level of CD >500nmol/L (5 μg/dl) is considered toxic)
2. urinary conc of B2 microglobulin.
24 hour urine. Specimen → Creatinine level in urine
CBC Hair & Fingernail clippings)
(Creatinine level in unine above 10 mg/dl) suggest Cadmium toxicity.
1043
ANNEXURE-V
MERCURY
Mercury is number 3 on ATSDR’s “Top 20 List”. It is generated naturally in the environment from
the degassing of the earth’s crust, from volcanic emissions. It exists in three forms: elemental
mercury and organic and inorganic mercury.
Sources : Mining operations, chloralkali plants, and paper industries are significant producers of
mercury (Goyer 1996).Mercury continues to be used in thermometers, thermostats, and dental
amalgam. (Many researchers suspect dental amalgam as being a possible source of mercury
toxicity [Omura et al. 1996; O’Brien 2001].) Medicines, such as mercurochrome and
merthiolate, are still available. Algaecides and childhood vaccines are also potential sources. People
who consume more than two fish meals a week are showing very high serum levels of mercury.
Absorption: Inhalation is the most frequent cause of exposure to mercury. The organic form is
readily absorbed in the gastrointestinal tract (90-100%); lesser but still significant amounts of
inorganic mercury are absorbed in the gastrointestinal tract (7-15%). Target organs are the brain
and kidneys (Roberts 1999; ATSDR ToxFAQs for Mercury).
Target Organs: Target organs are the brain and kidneys (Roberts 1999; ATSDR ToxFAQs for
Mercury).
Symptoms:
Symptoms of acute exposure are
• Cough
• Sore throat
• Shortness of breath
• Metallic taste in the mouth
• Abdominal pain
• Nausea,
• Vomiting
• Diarrhoea
• Headache
• Weakness
• Visual disturbances
• Tachycardia
• Hypertension.
1044
Chronic exposure to mercury may result in
• Permanent damage to the central nervous system (Ewan et al. 1996) and kidneys.
• Tremors
• Anxiety
• Forgetfulness
• Emotional instability
• Insomnia
• Fatigue
• Weakness
• Anorexia
• Loss of Cognitive functions
• Mercury can also cross the placenta from the mother to the fetus (levels in the fetus are
often double those in the mother) and accumulate, resulting in mental retardation, brain
damage, cerebral palsy, blindness, seizures, and inability to speak
Laboratory Investigations:
• Blood and urine samples are used to determine recent exposure, as well as exposure to
elemental mercury and inorganic forms of mercury.
• Blood mercury levels should not exceed 50 mcg/L (see the ATSDR Medical
Management Guidelines).
• A 24-hour urine specimen is collected for measurement of mercury levels.
• Chest x-rays can reveal a collection of mercury from exposure to elemental mercury or
a pulmonary embolism containing mercury (Ferner 2001).
• Abdominal x-rays can reveal swallowed mercury as it moves through the gastrointestinal
tract.
• Scalp hair is used in testing for exposure to methylmercury.
• Liver and kidney function tests are also important in severely exposed persons.
References
Harrison’s Principle of Internal Medicine 15th Edition page No.2590 –2595
MetalsasToxins:http://www.portfolio.mvm.ed.ac.uk/studentwebs/session2/group29/introtox.htm
http://www.medicine.uiowa.edu/Path_Handbook/indices/B.html http://www.lef.org/protocols/prtcl-
072.shtml#mostimpblt
1045
Blank
1046
OPEN OBSERVATIONAL STUDY ON CLINICAL
SAFETY OF SELECTED AYURVEDIC AND SIDDHA
HERBOMINERAL AND METALLIC PREPARATIONS
1047
Blank
1048
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
OPEN OBSERVATIONAL STUDY ON CLINICAL SAFETY OF SELECTED
(VASANTA KUSUMAKARA RASA) AYURVEDIC AND SIDDHA
HERBOMINERAL AND METALLIC PREPARATIONS
I. BACKGROUND
The use of metals in therapeutic drugs has become increasingly important over the last
couple of decades; Ayurveda recognizes their use long before that. Rasashastra, one among the
subspecialties of Ayurvedic Pharmaceuticals and Siddha classics have specified therapeutic use of
metals and minerals in the form of Bhasmas and Rasakalpas. As these drugs required in lesser
doses, causes no distaste unlike herbal drugs and faster in action, these practices became popular
and widely accepted and safely used since long.1
Heavy metals are chemical elements with a specific gravity that is at least 5 times the
specific gravity of water. There are 35 metals that concern us because of occupational or
residential exposure; 23 of these are the heavy elements or “heavy metals”: antimony, arsenic,
bismuth, cadmium, cerium, chromium, cobalt, copper, gallium, gold, iron, lead, manganese, mercury,
nickel, platinum, silver, tellurium, thallium, tin, uranium, vanadium, and zinc (Glanze 1996).
Interestingly, small amounts of these elements are common in our environment and diet and are
actually necessary for good health, but inappropriate dosage forms of any of them may cause
acute or chronic toxicity (poisoning).
Some well-known toxic metallic elements with a specific gravity that is 5 or more times
that of water are Arsenic, 5.7; Cadmium, 8.65; Iron, 7.9; Lead, 11.34; and Mercury, 13.546
(Lide 1992).2
Articles ( JAMA, Dec.15, 2004, Vol.292, No.23) published in some journals have
mentioned about the toxicity, presence of heavy metal contents of certain Ayurvedic Classical/
Proprietary preparations which is creating misconceptions among scientific communities and general
public regarding the safety of Ayurvedic/Siddha Rasa Kalpas and Bhasmas.
References
1. RasaRatna Samuchchaya, chapter 28/1.
2. http://www.lef.org/protocols/: Heavy Metal Toxicity
3. RasaRatna Samuchchaya, chapter 5/11,20,30,147.
1049
The classics of Ayurvedic Rasashastra and siddha system have specified different
methods of preparation and operational procedures since from the collection of raw drugs their
purification, processing, method of use, dosage forms etc. The raw drugs and finished products, if
not processed and preserved as per the classical literature specified, they may lead to improper
finished product with contaminants and may lead to toxic symptoms3. Thus this project is
undertaken to assess the heavy metal toxicity in patients receiving Ayurvedic /siddha preparations.
II. OBJECTIVES:
Observe the clinical/biochemical changes in subjects receiving Vasanta Kusumakara Rasa
- an Ayurvedic Herbomineral / Metallic preparations for ensuring Clinical safety
III. CENTRE: Identified CCRAS Institutes.
IV. SOURCE OF PROCUREMENT OF TRIAL DRUGS:
The selected Ayurvedic & Siddha drugs will be procured from IMPCL and IMPCOPS,
Chennai. The requisite quantities of all the drugs will be procured and supplied to the identified
Institutes and CSMDRIA, Chennai by Central Research Institute (Ay) New Delhi [from IMPCL],
Central Research Institute (Siddha), Chennai [from IMPCOPS]. The physico-chemical standards
will be evolved by Cpt. Srinivasa Murthy Drug Research Institute for Ayurveda, Chennai.
V. SAMPLE SIZE AND METHODS: - 15 subjects
TYPE OF STUDY : Open
LEVEL OF STUDY : OPD
PERIOD OF TREATMENT : 30 days
PERIOD OF STUDY : 6 months
DRUG & Details of treatment schedule
a) Drug- Vasanta Kusumakara Rasa
b) Diagnosis - Prameha, Dourbalya
c) Dosage schedule and duration - 60 mg BD for 30 days
d) Combinations with the main drug: Vasanta Kusumakara Rasa 60 mg. in 3 gms. of
Ashwagandha Churna.
e) Anupana [Vehicle]: Water.
VI. CRITERIA FOR INCLUSION:
1. Patients above 20 years and below 60 years of age.
2. Biochemical investigations for heavy metals at 0 day of assessment within the range.
1050
3. Clinically diagnosed cases of Prameha & Dourbalya
VII. CRITERIA FOR EXCLUSION:
1. Serum metallic levels of any of the metals exceeding permissible range at day 0 of
assessment
2. Age below 20 years & above 60 years
3. Known renal or Hepatic Pathology (Confirm by Clinical/Biochemical parameters)
4. Chronic Industrial Exposure
5. Patient receiving any other mineral preparation other than trial drug.
6. Major neuro-Psychiatric abnormalities
7. Chronic Smokers/Tobacco consumers
VIII. CRITERIA FOR WITHDRAWAL:
During the course of the trial treatment, if any serious condition or any serious adverse
events which requires urgent treatment or if patients himself want to withdraw from the study, such
subjects may be withdrawn from the trial.
IX. ROUTINE EXAMINATION AND ASSESSMENT:
Screening of the patients will be recorded as per case record form-I. The full details of
history and physical examination of the subjects will be recorded as per case record forms (Case
record form II). Clinical and physiological assessment (Case record form -III) and laboratory
investigations (Case report form -IV3) will be done before treatment, at 0, 15th & 30th days.
X. STATISTICAL ANALYSIS
Data on clinical symptoms and objective tests before and after the treatment will be
tabulated and analyzed using appropriate statistical tools. The data generated at the Institute on the
selected trial drug will have to be communicated to the Statistical Officer of CCRAS from time to
time through e-mail.
XI. CRITERIA FOR ASSESSMENT OF OUTCOME OF STUDY
The assessment of progress & outcome of the study are assessed on the basis of clinical
and biochemical investigations.
XII. TRIAL MONITORING AND DATA ANALYSES
The Statistical Section, CCRAS, Hqrs, New Delhi will undertake the monitoring of
progress of the trial and data analysis.
1051
XIII. ETHICAL REVIEW
Institutional Ethical Committee (IEC) of participating Center’s shall issue clearance
certificate before the project is initiated. Patient’s information sheet and informed consent form shall
be submitted along with project proposal for approval by IEC and maintained in duplicate with one
copy given to the patient at the time of entry to the trial.
XIV. TRAVELLING EXPENSES
A consolidated amount of Rs.100/- per visit (Total Rs.300/-) will be paid to the patient at
the end of the study.
XV. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
Short-term two-day training will be provided to the Investigators and Laboratory
personnel involved in this open observational trial at CCRAS Hqrs. and Central Research Institute
(Ay.), New Delhi. The investigators and technicians will be detailed about the clinical trial conduct
and laboratory procedures in order to maintain the uniformity.
XVI. LABORATORY INVESTIGATIONS
The Laboratory Investigations (Pathological / Biochemical, Radiological / Sonography etc.)
which are not available at research Institutes will be referred to any reputed/Government Institutes
under intimation to this Council following codal formalities.
XVII. FINANCIAL APPROVAL:
The financial implications as required for different purposes will be met from sanctioned
budget of the Institute concerned under the head Research Activities (Plan). All the procedures
should be executed following the codal formalities with necessary approvals of the Council.
1052
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
WRITTEN INFORMED CONSENT FORM
CERTIFICATE BY INVESTIGATOR
I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature of the subject: ______________
Name: ____________________________
CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending physician, the purpose of the trial
and the nature of drug treatment and follow-up, including the laboratory investigations to be
performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so.
I, exercising my free power of choice, hereby give my consent to be included as a subject
in the clinical trial on “Open Observational Study on Clinical Safety of Selected (Vasanta
Kusumakara Rasa) Ayurvedic / Siddha Herbomineral and Metallic Preparations.”
Relationship ___________________________________
1053
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
OPEN OBSERVATIONAL STUDY ON CLINICAL SAFETY OF SELECTED
(VASANTA KUSUMAKARA RASA) AYURVEDIC AND SIDDHA HERBOMINERAL
AND METALLIC PREPARATIONS.
PATIENT INFORMATION SHEET
1054
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
OPEN OBSERVATIONAL STUDY ON CLINICAL SAFETY OF SELECTED
(VASANTA KUSUMAKARA RASA) AYURVEDIC AND SIDDHA
HERBOMINERAL AND METALLIC PREPARATIONS.
CASE REPORT FORM I - SCREENING
BEFORE TREATMENT
(Enter a () in the appropriate box)
1. Centre: ………………..……….
6. Address Permanent postal address with phone number & email if any.
..............................................................................................................................
..............................................................................................................................
1055
7. Chronic Industrial Exposure
A patient is eligible for admission to the trial, only if sl. No.1 - 3 are “yes” & if the sl.
No. 4-10 are “no”.
1056
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
OPEN OBSERVATIONAL STUDY ON CLINICAL SAFETY OF SELECTED
(VASANTA KUSUMAKARA RASA) AYURVEDIC AND SIDDHA
HERBOMINERAL AND METALLIC PREPARATIONS.
CASE REPORT FORM II – HISTORY
1. Centre: ………………..……….
7. Address Permanent postal address with phone nu,ber & email if any.
Graduate 4 PG 5
Less than Rs. 60,000/- (1) More than Rs. 60,000/- (2)
10. Occupation:
No __________
Was there any significant exposure to dust, chemicals smoke or heavy metal
1057
No __________
Dosage) 4. —————————————————————
5. —————————————————————
Yes-1 No-2
If yes, details…………………………………………….....................................................
2. Previous episode
3. Duration of disease
1058
13. Personal History:
Tobacco chewing
Betel chewing
Prakriti
Sama 7
DIAGNOSIS:
OTHER SPECIFIC SYMPTOMS IF ANY WITH DURATION (0, 15th & 30thday)
2. Cough (Hg)
1059
5. Vomitting (As, Cd, Hg, Pb)
7. Thirst (Pb)
1060
28. Lack of Concentration (Pb)
PHYSICAL EXAMINATION
{ Weight (kg.)
B.M.I. ———————
Height (meters)2 } ________________
Systolic ________________
Diastolic ________________
1061
Absent(0) Present (1)
Pallor
Lymphadenopathy
Cyanosis (As)
Clubbing nails
Edema
Area __________________________________________________________________
Erythroderma (As)
Hyperkeratosis (As)
Hyperpigmentation (As)
CVS
If abnormal, details________________________________________________________
CNS
Respiratory system
1062
If abnormal, details _______________________________________________________
Digestive system
Urogenital system
1063
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
OPEN OBSERVATIONAL STUDY ON CLINICAL SAFETY OF SELECTED
(VASANTA KUSUMAKARA RASA) AYURVEDIC AND SIDDHA
HERBOMINERAL AND METALLIC PREPARATIONS.
CASE REPORT FORM III– CLINICAL AND PHYSIOLOGICAL ASSESSMENT
(0, 15th, 30thday)
1. Centre: ………………..……….
..............................................................................................................................
Email ID ..............................................................................................................
2. Cough (Hg)
1064
5. Vomitting (As, Cd, Hg, Pb)
7. Thirst (Pb)
1065
28. Lack of Concentration (Pb)
PHYSICAL EXAMINATION
{
Weight (kg.)
40. B.M.I. ———————
Height (meters)2 } ________________
47. Pallor
48. Lymphadenopathy
1066
49. Cyanosis (As)
51. Edema
CVS
If abnormal, details________________________________________________________
CNS
Respiratory system
Digestive system
1067
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
OPEN OBSERVATIONAL STUDY ON CLINICAL SAFETY OF SELECTED
(VASANTA KUSUMAKARA RASA) AYURVEDIC AND SIDDHA
HERBOMINERAL AND METALLIC PREPARATIONS.
CASE REPORT FORM IV – LABORATORY INVESTIGATIONS
(0, 15th, 30th days)
1. Centre: ………………..……….
Urine Examination
8. Routine____________ Microscopic___________
Pb___________
Cd___________
Hg___________
Haematological Investigations
Pb ___________
Cd ___________
Hg ___________
1068
11. Hb (g/dl) _______________________________
DLC
Blood Sugar
27. S.Bilirubin(mg./dL)
a. Total __________________
b. Direct __________________
1069
c. Indirect __________________
_____________________________________________
Place:_____________
1070
ANNEXURE-I
1071
Children and adults < 10 ug/dl hour) 0 - 31 ug/d
Exposed: Children (0-6 years) Lead per gm of
> 10 ug/dl Creatinine
Adults (occupational exposure) No reference
OSHA action level 40ug/dl interval (ug/g CRT)
BEI (Biological Exposure 30
ug/dl
Index) (sampling time not
critical)
BAT (Biological Tolerance 70
ug/dl
Value) (sampling time not
critical)
Toxic: Children (0-6 years) >
70 ug/dl
Adults > 80 ug/dl
3. Cadmium 0.0 - 5.0 mcg/L Cadmium, Urine Urine (24 hr.)
0.0-2.6 ug/L CBC
Cadmium, Urine Hair Fingernail
(24-hour) 0.0-3.3
ug/d
Cadmium per
gram of creatinine
0.0-3.0 ug/g crt
4. Mercury Mercury (blood): (Mercury Mercury, Urine = Urine (24hr.)
measured as total mercury 0-10 ug/L Scalp hair
(inorganic, organic, and metallic). Mercury, Urine
Reporting Limit: 5 ng/ml (24-Hour) = 0-15
Reference Range: Up to 15 ng/ ug/d
ml Mercury per gram
Normal (unexposed population): of creatinine = No
less than 8 ng/ml reference interval
Exposed: (ug/g CRT)
BEI (Biological Exposure
Index): 15 ng/ml (total
inorganic) (end of shift, end of
workweek)
1072
BAT (Biological Tolerance
Value) 50 ng/ml (metallic and
inorganic)
BAT (Biological Tolerance
Value): 100 ng/ml (organic)
References
1. Harrison’s Principle of Internal Medicine 15th Edition page No.2590 –2595
2. http://www.medicine.uiowa.edu/Path_Handbook/indices/B.html
1073
ANNEXURE-II
LEAD
Lead is number 2 on the ATSDR’s “Top 20 List.”
Source: Every year, industry produces about 2.5 million tons of lead throughout the world. Most
of this lead is used for batteries. The remainder is used for cable coverings, plumbing, ammunition,
and fuel additives. Other uses are as paint pigments and in PVC plastics, x-ray shielding, crystal
glass production, pencils, and pesticides.
The inorganic forms of lead are absorbed through ingestion or inhalation, whereas organic lead salts
are absorbed through the skin. Only about 10% of an ingested dose is absorbed in adults, but the
absorbed percentage may be much greater in children. Lead absorption is enhanced by
deficiencies of iron, calcium, and zinc.
Targeted organs: Bones, Brain, Blood, kidneys, and thyroid gland (International Occupational
Safety and Health Information Centre 1999; ATSDR ToxFAQs for Lead).
Half Life: Some authorities list the half-life of lead in the bone as long as 30 years, while others
estimate the lead half-life in bone to be 105 days. Generally, excretion of lead is slow, with an
estimated biologic half-life in soft tissues of 24-40 days. The remainder of the stored lead is found
in soft tissue, notably the kidney and brain.
Excretion: The primary route of excretion is through feces (80-90%). To a lesser extent, lead is
excreted in urine (10%). Lead passes the placental barrier and is found in breast milk.
Clinical Features – A patient with lead poisoning may have a combination of symptoms - or no
symptoms at all until the condition has progressed.
Acute Poisoning
Alimentary System - Thirst
Metallic taste in mouth
Nausea
Colic (Abdominal pain)
Diarrhoea
Loss of appetite (Anorexia)
CNS Parasthesia (numbness) Hallucination
Muscle pain Vertigo
Fatigue Lethargy
Convulsions Ataxia
1074
Slurred speech Sleeplessness
Loss of consciousness
CVS Hypotension / Hypertension
Circulatory collapse
Blood Pallor (Severe Anemia – acute hemolytic crisis)
Renal System Oliguria
Chronic Poisoning
Births defects Shaky hand Numbness
Mental Retardation Muscular weakness lack of concentration
Autism Paralysis (Beginning in fore arms) Psychosis
Allergies Arthritis Colic
Dyslexia Hyper activity Weight loss
Mood swings Nausea
Leadline in gingival
Seizures
Chronic subclinical exposure to lead is associated
Interstitial nephritis,
Tubular damage
Hyperuricaemia
Oliguria (decline in GFR)
Chronic Renal Failure.
Blood lead levels in the range of 0.34 – 1.7 μmol/lit are associated with
• Increase in blood Pressure
• Decrease in creatinine clearance
• Decrements in cognitive performance
Laboratory Investigation -
1. Blood Test
(i) Blood Lead levels (N) blood level of lead < 1.9 μmol/L (40 μg/dl)
In children > 10 mcg/dl;
In Adults > 40 μ/dl are considered to be of concern
1075
(ii) Complete Blood Count (CBC) – (Normochromic, Normocytic anemia with
Basophilic stipplings on red cells in lead poisoning)
(iii) Serum Creatinine level (Elevated in chronic lead poisoning)
2. Long bone X-ray (in Children) (May reveal bands that indicate the failure of the bone to
rebuild)
3. Measurement of lead in teeth
4. Levels of lead in Urine [ Random urine < 150 μg/g creatinine (Not provoked with a
chelator) ]
5. Levels of lead in Faeces
6. Nerve Conduction Time (To know nerve induced peripheral demyelination)
7. Bone Lead Levels- k- ray-Flourescence
1076
ARSENIC
ANNEXURE-III
Arsenic is the most common cause of acute heavy metal poisoning in adults and is number
1 on the ATSDR’s “Top 20 List.
Sources: Sources of arsenic include
• Pesticides
• Herbicides
• Fungicides
• Wood preservatives
• Ceramic enamels
• Paints
• Tobacco (There may be as much as 6 micrograms per pack)
• Burning of Fossil fuels as arsenic is a contaminant
Occupational exposure can occur in
• The Smelting Industry (arsenic is a by –product of ores containing lead,gold,zinc,cobalt and
nickel)
• The microelectronics Industry
• Coal Power Plants
• Jobs involving the manufacturing of glass and fireworks
• Jobs with contact with pesticides
• Jobs with contact with wood treated with arsenic as a preservative
Absorption – Absorbed through skin, lungs and GIT
Targeted Organ: Target organs are the blood, kidneys, and central nervous, digestive, and skin
systems.
After absorption of inorganic arsenic, the compound accumulates in the liver, spleen,
kidneys, lungs and gastrointestinal tract. It is then rapidly cleared from these tissues but it leaves
a residue in Keratin rich tissues such as skin, hair and nails.
Metabolism Inorganic compounds are absorbed more readily than organic 80% of this is
ingested through GIT.
Blood 24 hour liver, kidney, lung and spleen
2 weeks skin, hair & bone.
1077
Inorganic salts in - leukocytes
1078
Hyperkeratosis
Hyperpigmentation
Exfoliative Dermatitis
Aldrich Mees lines (Transverse white striae on the fingernails)
Mucous Membrane
• Laryngitis
• Tracheitis
• Bronchitis
CNS • Polyneuritis (sensory & Motor)
• Basal cell carcinomas
• Squamous cell carcinomas
Other effects • Capillary injury
Necrosis of stomach, small bowel, vascular & degenerative changes in liver
& kidney
Laboratory Investigations-
Arsenic levels can be measured in blood, urine, hair and fingernails. Urine tests are most reliable
1. X-ray abdomen - (As is radio opaque and is seen on x-ray of abdomen).
2. ECG- (QRS complex broadening, QT prolongation, ST segment depression, T wave
flattening & multifocal ventricular tachycardia)
3. LFT (abnormal)
4. Hb (anaemia)
5. Leukopenia/ Leukocytosis
6. Protein urea
7. Hematuria
8. Cellular casts in the urine
9. Urine Arsenic levels (normally less than 67 nmol 5 μg/d)
10. May also be detected in hairs & nails for months following exposure.
1079
ANNEXURE-IV
CADMIUM
Cadmium is a byproduct of the mining and smelting of lead and zinc and is number 7 on
ATSDR’s “Top 20 list.”
(Absorbed Cd is mostly concentrated in liver and kidneys)
Sources – Cadmium has a wide variety of sources in the environment and from industry. One
source is from ingestion of grown foodstuffs, especially grain and leafy vegetables, which readily
absorb cadmium from the soil. The cadmium may occur naturally or as a contaminant and the
contaminants include sewage, sludge fertilizers, polluted ground water and mining effluents.
Cadmium is also a constituent of alloys, pigments, batteries, metal coatings for example protective
coating on steel, plastics and fertilizers. Occupational exposure may occur from the manufacture of
these products and from welding, and smelting of lead, zinc and copper as these occur in mixed
ores with cadmium. Cadmium is also found in Cigarette fumes and fumes from vehicles.
Absorption: Inhalation accounts for 15-50% of absorption through the respiratory system; 2-7%
of ingested cadmium is absorbed in the gastrointestinal system.
Target organs - Target organs are the liver, placenta, kidneys, lungs, brain, and bones (Roberts
1999; ATSDR ToxFAQs for Cadmium).
Clinical Toxicology – (4-24 h)
Acute - High dose Cd inhalation can cause severe respiratory irritation.
Pleuritic chest pain
Dysponea
Cyanosis
Fever
Tachycardia
Nauses
Pulmonary edema (non cardiogenic)
COPD
Renal Disease
Fragile bones
Emphysema
1080
Through Ingestion (Acute)
Nauses
Vomiting
Salivation
Abdominal cramps
Diarrhoea
Chronic
Anosmia - Alopecia
Yellowing of the teeth - Anaemia
Emphysema - arthritis
Minor changes in the liver function - learning disorders
Micorocytic hypochronic anemia
(unresponsive to iron therapy) - migraines
Renal tubular dysfunction
(Proteinuria & increased excretion of B2 microglobulin) - growth impairment
Osteomalacia (bone lesions & Pseudofractures)
Osteoporosis, Loss of taste & smell. Poor appetite
Lab. Findings.
1. Blood level of CD >500nmol/L (5 μg/dl) is considered toxic)
2. urinary conc of B2 microglobulin.
24 hour urine. Specimen → Creatinine level in urine
CBC Hair & Fingernail clippings)
(Creatinine level in unine above 10 mg/dl) suggest Cadmium toxicity.
1081
ANNEXURE-V
MERCURY
Mercury is number 3 on ATSDR’s “Top 20 List”. It is generated naturally in the environment from
the degassing of the earth’s crust, from volcanic emissions. It exists in three forms: elemental
mercury and organic and inorganic mercury.
Sources : Mining operations, chloralkali plants, and paper industries are significant producers of
mercury (Goyer 1996).Mercury continues to be used in thermometers, thermostats, and dental
amalgam. (Many researchers suspect dental amalgam as being a possible source of mercury
toxicity [Omura et al. 1996; O’Brien 2001].) Medicines, such as mercurochrome and
merthiolate, are still available. Algaecides and childhood vaccines are also potential sources. People
who consume more than two fish meals a week are showing very high serum levels of mercury.
Absorption: Inhalation is the most frequent cause of exposure to mercury. The organic form is
readily absorbed in the gastrointestinal tract (90-100%); lesser but still significant amounts of
inorganic mercury are absorbed in the gastrointestinal tract (7-15%). Target organs are the brain
and kidneys (Roberts 1999; ATSDR ToxFAQs for Mercury).
Target Organs: Target organs are the brain and kidneys (Roberts 1999; ATSDR ToxFAQs for
Mercury).
Symptoms:
Symptoms of acute exposure are
• Cough
• Sore throat
• Shortness of breath
• Metallic taste in the mouth
• Abdominal pain
• Nausea,
• Vomiting
• Diarrhoea
• Headache
• Weakness
• Visual disturbances
• Tachycardia
• Hypertension.
1082
Chronic exposure to mercury may result in
• Permanent damage to the central nervous system (Ewan et al. 1996) and kidneys.
• Tremors
• Anxiety
• Forgetfulness
• Emotional instability
• Insomnia
• Fatigue
• Weakness
• Anorexia
• Loss of Cognitive functions
• Mercury can also cross the placenta from the mother to the fetus (levels in the fetus are
often double those in the mother) and accumulate, resulting in mental retardation, brain
damage, cerebral palsy, blindness, seizures, and inability to speak
Laboratory Investigations:
• Blood and urine samples are used to determine recent exposure, as well as exposure to
elemental mercury and inorganic forms of mercury.
• Blood mercury levels should not exceed 50 mcg/L (see the ATSDR Medical
Management Guidelines).
• A 24-hour urine specimen is collected for measurement of mercury levels.
• Chest x-rays can reveal a collection of mercury from exposure to elemental mercury or
a pulmonary embolism containing mercury (Ferner 2001).
• Abdominal x-rays can reveal swallowed mercury as it moves through the gastrointestinal
tract.
• Scalp hair is used in testing for exposure to methylmercury.
• Liver and kidney function tests are also important in severely exposed persons.
1083
Blank
1084
SECTION-XIX
ANNEXURE
Blank
1086
Annexure-I
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
(Enter a in the appropriate box)
CASE REPORT FORM FOR DETERMINATION OF PRAKRUTI /
UDALIYAL/MIZAJ
1087
b. Feel fresh. Feel well even with less sleep.
c. Feel fresh but not good when have less hours of sleep.
1.06 Dreams (DM)
a. Cool and peaceful dreams, not bothers to remember
b. Passionate dreams, sees heat, light & remembers well
c. Plenty of dreams, mostly related to motion, usually forgets
1.07 Physical working capacity/physical strength
a. Starts with speed & gets exhausted easily
b. Loves hard work, has moderate capacity
c. Good stamina but slow and not interested for physical work.
1.08 Performance of activities
a. Quickly with a lot of initiative
b. Moderately with medium initiative
c. Slow, steady and balance activities
1.09 Talking
a. Very fast missing words
b. Sharp, provocative and clear-cut
c. Slow, clear and stable
1.10 Walking
a. Very quick with swift movement
b. Normal and rhythm
c. Slow and steady
1.11 Associated movements of body while working
a. Excessive and frequent, difficult to tolerate
b. Less thirst, easy to tolerate
c. Moderate perspiration, consistent to climate, with pleasant smell.
1088
1.12 Nature of Thirst (TN)
a. Excessive and frequent, difficult to tolerate
b. Less thirst, easy to tolerate
c. Moderate and variable thirst
1.13 Status of Perspiration (SP)
a. Scanty even in hot climate but odourless
b. Profuse with strong odour
c. Moderate perspiration, consistent to climate, with pleasant smell.
1.14 Sexual qualities (SQ)
a. Variable, strong desire, overindulgence, & gets exhausted
b. Moderate with domina ting behavior
c. Usually low and steady desire, with good stamina
1.15 Quantity of seminal discharge
a. Scanty and comparatively thin in consistency
b. Moderate and normal
c. Plenty and thick
1.16 Fertility or productivity
a. Comparatively lesser
b. Less
c. Capable of producing good no. of off springs
1.17 Longevity or average age
a. Short life span
b. Moderate life span
c. Long life span
1.18 Resistance to diseases (RD)
a. Usually poor. Frequently fall ill.
b. Medium
1089
c. Good. Able to tolerate seasonal variation, food etc. well
1.19 Climatic Preferences (CP)
a. Prefers warm, avoids cold climate
b. Likes cold, but intolerant to warm/hot
c. Likes normal climate & prefers warm in comparison to cold
2. MENTAL/PSYCHOLOGICAL STATUS:
2.01 Mental Reactions (MR)/Personality Traits:
a. Very sensitive, reacts quickly
b. Gets Irritated easily & sustains it.
c. Cool, calm, avoids confrontations
2.02 Memory Status (MS)
a. Remembers easily & tends to forget easily
b. Takes time to grasp, but retains for long
c. Remembers easily and tends to retain
2.03 Leadership quality (LQ)
a. Don’t like to lead and happy as a follower.
b. Requires commanding status.
c. Avoid leading.
2.04 Decision making capacity(DMC)
a. Takes immediate decision without thinking much.
b. Takes decision after properly analyzing the facts.
c. Avoid taking decision. Usually keeps them pending.
2.05 Concentration Power (CP)
a. Very easy to concentrate on a work, but not for long duration
b. Difficult to concentrate on a work
c. Retains concentration for a long period
1090
2.06 Attitude towards problems or difficulties
Lot of worrying, instability in reaction
Angry, over awed, easily provoked and highly irritable
Peaceful, slow, steady and balance
2.07 Nature
a. Easily irritable, irritating to others, exaggerating, anxious materialistic liking
b. Polite but hot-tempered, proudy, brave, bold, less but good friendship
c. Polite, decent, not greedy, appreciating, have good and long lasting friendship
2.08 Liking about taste (TL)
a. Sweet, salt & sour
b. Sweet, bitter & astringent
c. Pungent, astringent & bitter
3. PHYSICAL FEATURES: (PF)
3.01 Body frame (BF)
a. Thin body frame, unusually long/short
b. Medium frame
c. Broad, Large frame
3.02 Body weight (BW)
a. Moderate/Average weight
b. Underweight or Tendency of fluctuation
c. Over weight or with a tendency to gain weight
3.03 Distribution of body fat (DBF)
a. Unequal/on specific areas
b. Evenly distribution
c. Scanty deposition of body fat.
3.04 Nature/Texture of skin
a. Delicate, Irritable skin, gets wrinkles easily
1091
b. Dry, rough, cracked, or having a tendency of cracking
c. Smooth, firm, soft, clear with good lusture, not prone to disorders
3.05 Complexion/skin color (SC)
a. Extremely fair / pinkish
b. Fair, reddish, burns easily
c. Comparatively dull or darkish, tans easily
3.06 Body Hair (BH)
a. Dry, rough, coarse, lustureless & curly
b. Soft, scanty, straight, fine textured
c. Thick, shiny, moderate
3.07 Forehead (FH)
a. Large
b. Medium
c. Small
3.08 Eyes (EF)
a. Rolling, restless, small, dull & lusterless
b. Sharp, medium sized with sclera of reddish tinge
c. Large calm stable eyes with milky white sclera
3.09 Teeth (TE)
a. Teeth are of average size, yellowish, prone to cavities
b. Dry, cracked, irregular dull white
c. Large, even, gleaming white
3.10 Tongue (TO)
a. Thin tongue, with blackish spots, often coated with thin adherent coating
b. Medium, Reddish, occasionally coated with yellow or red coating
c. Thick usually clear, rarely coated, coating is usually thick white
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3.11 Lips (LP)
a. Soft, moist & reddish
b. Dry, thin & blackish
c. Thick & glossy
3.12 Blood Vessels (BV)
a. Prominent
b. Less prominent
c. Not visible
3.13 Scalp Hair (SH)
a. Dark in Shade, coarse, rough, easily prone to dandruff and split ends.
b. Thin, delicate, straight, light coloured, turn grey at an early age
c. Strong, thick, dark, slightly wavy with good lusture, oiliness is usually
one of the chief complaints
3.14 Joints (JT)
a. Crackling joints, hyper mobile in nature
b. Comparatively normal but have soft and loose ligaments
c. Well lubricated, strongly built joints which are well organized, well covered
3.15 Voice (VR)
a. Rough, unclear voice, which turns hoarse or cracks on strain
b. Concise, sharp voice, intense in nature & high pitched
c. Deep, pleasant, resonant voice which is melodious, resonating,
but lower in pitch and intensity
3.16 Nail (NL)
a. Hard, brittle, rough & differ in size from one another, bluish/grayish in
contour
b. Soft, Strong, well formed, Lustrous, pink in colour
c. Strong, large, thick symmetrical & somewhat pale in colour
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3.17 Body temperature
a. Feels slightly cold on touch
b. Feels slightly warm on touch
c. Normal
3.18 Shape of Palms and feet
a. Short and broad
b. Medium and slim
c. Long and broad
3.19 Face
a. Small and broad with uneven features
b. Medium & oval with sharply defined features
c. Round, babbly and attractive with balance features
4 Social or economical status
4.01 Economy
a. Getting less outcome with hard work
b. Getting good outcome with moderate efforts
c. Enjoys lavishly and royal life
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SCORE SHEET FOR DETERMINATION OF PRAKRUTI /UDALIYAL /MIZAJ
Sl. no. of the subject_________________________________________________________
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25. 2.06 V P K
26. 2.07 V P K
27. 2.08 V P K
28. 3.01 V P K
29. 3.02 P V K
30. 3.03 K P V
31. 3.04 P V K
32. 3.05 K P V
33. 3.06 V P K
34. 3.07 K P V
35. 3.08 V P K
36. 3.09 P V K
37. 3.10 V P K
38. 3.11 P V K
39. 3.12 V P K
40. 3.13 V P K
41. 3.14 V P K
42. 3.15 V P K
43. 3.16 V P K
44. 3.17 V P K
45. 3.18 V P K
46. 3.19 V P K
47. 4.01 V P K
INDIVIDUAL SCORE OF VPK V P K
PERCENTAGE OF VPK V= P= K=
TYPE OF PRAKRITI /UDALIYAL/ MIZAJ
Abbreviations-V- Vata /Vali/Sauda, P- Pitta /Azhal/Safra, K- Kapha/ Iyam/Balgam
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