RANDOMISED DOUBLE BLIND CONTROLLED

CLINICAL TRIAL OF AYUSH-DIAB IN CONTROLLING

BLOOD SUGAR LEVEL IN Type 2 DIABETES
MELLITUS

Drug :

Study Code:

PROTOCOL & CASE REPORT FORMS (CRF)

CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA

AND SIDDHA
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA

RANDOMISED DOUBLE BLINDCONTROLLED CLINICAL TRIAL OF AYUSHDIAB 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.

Harrisons 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 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.
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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. Patients
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.

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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.

Date:___________

Name of the Subject:_____________________________

Signature or Thumb impression_____________________

Date:___________

Name of witness: _______________________________

Signature or Thumb impression: _____________________
Relationship ___________________________________

To be translated into regional language.

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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
What is the study about?
Research is going on to find a suitable natural product for the treatment of Type-2
Diabetes mellitus. You are invited to participate in such a study in which you will receive either
Ayurvedic trial drugs or control drug for 24 weeks.
The aim of the present study is to assess the anti-diabetic effect of these drugs in the
management of Type 2 Diabetes mellitus patients.
Total 100 patients from this and other hospitals will be taking part in this 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 six months to complete. After this
period, you are expected to visit the hospital every fortnight. The interval between the first and
second visit will be around 15 days.
Before you start treatment, during the first visit to the clinic, you will undergo a complete
physical examination. ECG, Blood and urine samples will also be taken. This is to make sure that
you are eligible for the study.
One week later, at your second visit, if you are eligible, you would be put on trial treatment
for 24 weeks. You may receive either trial drug or control drug for 24 weeks. You should follow
life style modifications (Diets Advice, Exercise) as given along with information Sheet.
From the first visit onwards, you will be required to fast overnight before attending each
visit. Blood and urine samples will be taken at every visit. At each visit, you will be supplied with
sufficient quantity of drug to last until your next visit.
What happens at the end of the study?
The trial treatment will be stopped at the end of 24 weeks. You will be put back on an
appropriate treatment available in the market.

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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 incoordination. 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 doctors 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

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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]
DONT
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

To be translated into regional language.

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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA

RANDOMISED DOUBLE BLINDCONTROLLED CLINICAL TRIAL OF AYUSHDIAB IN CONTROLLING BLOOD SUGAR LEVEL IN Type 2 DIABETES
MELLITUS
CASE REPORT FORM I - SCREENING
1.

Centre: ______________________________

2.

Name of the subject: ______________________________________________________

3.

Sr. No. of the Subject : ____________________________________________________

4.

Address : _______________________________________________________________

5.

Date of Birth:

6.

Code No. (of clinical trial)

7.

Gender

Age (in yrs.) :

Male

Female

CRITERIA OF INCLUSION
1.

Age between 30 years to 65 years

2.

If yes in any of the three

2
Yes (1)

No (2)

Blood sugar Fasting > 26 and =< 200 mg/dl or

PP > 200 mg/dl and<= 350 mg/dl or
Glycated haemoglobin>7% and <10%
3.

Recently diagnosed (< 6 Months)

Cases of Type-2 Diabetes mellitus
Not taking any hypoglycemic drug or insulin.

CRITERIA FOR EXCLUSION

4.

Yes (1)

Age below 30 and above 65 years.

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No (0))

5.

If yes in any of the three

Blood sugar Fasting =< 126 and > than 200 or
PP=< 200 mg/dl >350 mg/dl or
Glycated haemoglobin<=7% and =>10%

6.

Malignant and accelerated hypertensive

7.

CVS disorder (CAD)

8.

Pregnant woman or the women planning to be pregnant

in next six months

9.

Lactating mothers

10. Secondary Diabetes mellitus

11. Patient under going regular treatment for Diabetes or
for any other severe illness
12. CNS disorder e.g. encephalopathy

A patient is eligible for admission

If Yes to S.No.1 3 & No to 4 12
If admitted:

Sl. No. of the subject ____________

No. of packets issued____________

Date:____________

Signature of the Investigator _____________

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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA

RANDOMISED DOUBLE BLINDCONTROLLED CLINICAL TRIAL OF AYUSHDIAB IN CONTROLLING BLOOD SUGAR LEVEL IN Type 2 DIABETES
MELLITUS
CASE REPORT FORM II HISTORY
1.

Centre: ______________________________

2.

Code No. (of clinical trial)

3.

Sr. No. of the subject: ____________________________________________________

4.

Name of the subject: ______________________________________________________

5.

Address : _______________________________________________________________

6.

Gender

7.

Date of Birth:

8.

Educational status:

Male

Occupation

Female

Age (in yrs.) :

Illiterate

9.

Read and write

Primary

Middle school 4

High school

College

Others (specify) 7

INA

Desk work

Field work

Field work with physical labour

Field work with intellectual

Indicate nature of work.................................

10. Total Family members :
11. Income per capita per month (in Rs.) :
12. Religion :

Hindu

Muslim

Christian

Parsi

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Sikh

Chief complaint with duration (if any) in days

Absent (0)

Present (1)

Duration

13. Polyuria (Excessive Urine)

14. Polyphagia (Excessive Hunger)
15. Polydipsia (Excessive Thirst)
16. Exhaustion/Tiredness
17. Loss of body weight
18. Body ache
19. Giddiness
20. Polyneuritis(Numbness / Tingling)
21. Visual disturbance
22. Others
If Yes specify: _____________________________________
Personal History
23. Diet

Veg.

Non-veg.

24. Presence of anxiety No

Yes

25. Constipation

No

Yes

No

Yes

Lecto-veg

Addiction
26. Smoking
If yes specify:

27. Tobacco
If yes specify:

(a) Quantity [packs]:

________________

(b) Total Duration in years

________________

No

Yes

(a) Quantity:

________________

(b) Total Duration in years

________________

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28. Alcohol

No

If yes specify:

Yes

(a) Quantity (in ml/day):

________________

(b) Total Duration in years

________________

29. Any other(specify) _____________________

30. Prakriti:

Vata

Pitta

Kapha

Vata-kaphaj

Vata-pittaja

Pitta-Kaphaja

Sannipataj

Physical Examination
31. Height (cm)

____________

32. Weight (kg)

____________

33. Pulse (per min)

____________

34. Blood Pressure (in sitting position)

Systolic_________________(mm Hg)
Diastolic ________________(mm Hg)
35. Body temperature (o F) _____________
36. Respiration rate (per min) _____________
37. Signs of dehydration and oedema, if any____________________
SYSTEMIC EXAMINATION

Absent (0)

Present (1)

38. CVS
If abnormal, details _______________________________________________________
39. CNS
If abnormal, details _______________________________________________________

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40. Digestive system

If abnormal, details _______________________________________________________
41. Uro-Genital system
If abnormal, details _______________________________________________________
42. Respiratory system
If abnormal, details _______________________________________________________

Date: ____________________

Signature of Investigator ___________________

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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA

RANDOMISED DOUBLE BLINDCONTROLLED CLINICAL TRIAL OF AYUSHDIAB IN CONTROLLING BLOOD SUGAR LEVEL IN Type 2 DIABETES
MELLITUS
CASE REPORT FORM III - CLINICAL & PHYSIOLOGICAL ASSESSMENT
[Before Treatment & Fortnightly During Treatment]
1.

Centre: ______________________________

2.

Code No. (of clinical trial)

3.

Sr. No. of the subject: ____________________________________________________

4.

Name of the subject: ______________________________________________________

5.

Address : _______________________________________________________________

6.

Gender

7.

Date of Birth:

8.

Date of Assessment :

Male

Female

Age (in yrs.) :

Chief complaint with duration (if any) in days

Absent (0)
9.

Polyuria (Excessive Urine)

10. Polyphagia (Excessive Hunger)

11. Polydipsia (Excessive Thirst)
12. Exhaustion/Tiredness
13. Bodyache
14. Giddiness
15. Polyneuritis (Numbness / Tingling)

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Present (1)

Duration
(in days)

16. Visual disturbance

17. Others
If Yes, specify: ___________________________________________________________
Physiological Assessment
18. Weight (in Kgs.) ______________
19. Blood Pressure (in sitting position)
Systolic_________________ (mm Hg)
Diastolic ________________ (mm Hg)

Date: ______________

Signature of Investigator: _________________________

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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA

RANDOMISED DOUBLE BLINDCONTROLLED CLINICAL TRIAL OF AYUSHDIAB IN CONTROLLING BLOOD SUGAR LEVEL IN Type 2 DIABETES
MELLITUS
CASE REPORT FORM IV- LABORATORY INVESTIGATION
1.

Centre: ______________________________

2.

Code No. (of clinical trial)

3.

Sr. No. of the subject: _____________________________________________________

4.

Name of the subject: _______________________________________________________

5.

Address : _______________________________________________________________

6.

Gender

7.

Date of Birth:

8.

Date of Assessment :

Male

Age (in yrs.) :

Urine Examination
Routine
9.

Sugar

10. Albumin

____________
____________

11. Deposits ____________

Microscopic
12. Pus cell

____________(hpf)

13. RBC

____________(hpf)

14. Cast

____________(hpf)

Stool examination
15. Routine

Female

____________
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Microscopic
16. Ova

____________

17. Cyst

____________

18. Occult Blood__________

Blood
19. TC (Cells/Cmm.): ____________
20. DC:

P(%)_____ L(%)_____ E(%)_____ M(%)_____ B(%)_____

21. Hb (g/dl)

____________

22. (1st hour.) ____________

23. Blood Sugar- Fasting/PP (mg./dl)____________/____________
24. Glycosylated) HbA1c (to be done before treatment
after three months and end of treatment)
25. Blood Urea (mg. /dl)

____________

26. S.Creatinine (mg./dl)

____________

27. Uric acid (mg./dl)

____________

LIPID PROFILE
28. Serum total Cholesterol (mg./dl) ____________
29. S. Triglycerides (mg./dl) ____________
30. HDL (mg./dl)

____________

31. LDL (mg./dl)

____________

32. VLDL (mg/dl)

____________

LIVER FUNCTION TEST

Serum Bilirubin
33. Total (mg/dl)

____________
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34. Direct (mg/dl)

____________

35. SGOT (IU/L)

____________

36. SGPT (IU/L)

____________

37. Alk.Phosphatase (KA units) ____________

38. Total proteins (gm./dl)

____________

39. Albumin (gm./dl)

____________

40. Globulin (gm./dl)

____________

41. A/G Ratio

____________

Serum Electrolytes
42. Sodium(mEq/L)

____________

43. Potasium(mEq/L)

____________

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.

Date: ______________

Signature of Investigator__________________________

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