TITLE & SYNOPSIS

Sr.
Item Guidelines
No.

01) Title :- COMPARITIVE CONTROLLED CLINICAL STUDY TO EVALUATE THE

EFFICACY OF SHIGRUMOOL VATI AND GOKSHUR CHURNA IN THE
MANAGEMENT OF MOOTRASHMARI (UROLITHIASIS).

02) Research Question :-

Whether Shigrumool Vati effective in management of Mootrashmari?

03) Hypothesis :- NULL HYPOTHESIS:

Shigrumool Vati is not effective in the management of Mootrashmari.

ALTERNATE HYPOTHESIS:

Shigrumool Vati is effective in the management Mootrashmari.

04) Introduction :- INTRODUCTION:

:
. . / .

Mootrashmari affects 1% to 5% of the population in the industrialized

countries. However, the incidence of Mootrashmari is higher in developing
countries (Such as India) than industrialized countries. It has been hypothesized
that the major etiological factor associated with the development of Mootrashmari
is the consumption of cereals, as they are the main source of dietary proteins. The
northern and northwestern regions of India are referred to as endemic
stone-forming areas, due to a dietary pattern that is rich in cereals and pulses.
The sequence of events in the formation of any urinary stone includes urinary
saturation, then super saturation which causes crystal growth, then crystal

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 aggregation. Further there will be crystal retention and lastly crystal stone
formation takes place. Renal stone < 8 mm in diameter are most likely to be
flushed out through urine. If it is > 8 mm in diameter, it has to be removed either
through surgery or through lithotripsy.
Study Rationale:
Mootrashmari is considered as one among the Ashtamahagada mentioned by
Sushrutacharya, as the condition is difficult to cure.The contemporary science has
limitationsin this condition.The severity and consequences of this disease can be
elicited. If not treated in appropriate time, disease may prove fatal. The main
treatment of Urinary Calculus falls in four categories viz.
1. Conservative
2. Medical
3. Non-Operative (Forced Hydrouresis)
4. Operative
Operative procedures are quite expensive & prove risky at
times .Especially the rate of recurrence is about 70% to 80% in people with first
incidence. So, its difficult to undergo surgery repeatedly .inspite of being highly
expensive. Hence its necessary to find out an inexpensive , effective, easily
available, easily preparable& acceptable medicine to treat Mootrashmari which
very less disadvantages.
Epidemiological Data :
Epidemiology of urolithiasis differs according to geographical area
&historical period. Changing socioeconomical conditions have generated
changes in the incidences of urolithiasis. Calcium Oxalate & Phosphate is currently
more frequent in economically developed countries. Prevalence rate 4% & 20%.
Annual incidence of hospitalization for calculosis ranges from 0.03 0.1%.
In Europe, Northern America, Australia, Japan, & more recently, Saudi Arabia
affluence has spread to all social classes & with it the tendency to eat rich food in
large quantities. Ca Oxalate / Phosphate Stones account for almost 70% of all
renal stones. In 70s pathogenic role for Ca Oxalate stones of a diet rich in
proteins, refined carbohydrate & sodium has become evident.
However, the concurrence of a genetic predisposition seem to be crucial
for Calcium stone formation.

In Ayurveda number of drugs and formulations are mentioned to treat

mootrashmari, among theseShigrumoolis selected for study .

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 Shigrumool Vati contains

Shigrumool Churna
This Drugs is easily available, economically feasible and easy to administer.

05) Review of Literature :- REVIEW OF LITERATURE:-

1) Important Ayurvedic and contemporary science texts.

2) Review of previous study will be done.

3) Internet sites

06) Objectives :- Primary Objective :

1.To study the effect of ShigrumoolVati in Mootrashmari.
Secondary Objective :
1.To reduce the duration of and easy , painless expulsion of urinary calculus.
2. To study the size of mootrashmri and number of expelled calculi after treatment.
3. Study of shigrumool and gokshur (from literary point of view).
4. To asses safety of shigrumool vati in mootrashmari.

Type of study design Comparitive Controlled Clinical Study

07) Methodology :-
A) Conceptual study -
Relevant Ayurvedic and contemporary medical science texts of important
Publications an
Internet will be used.
DRUG REVIEW-

DRUG STUDY

: :



..

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 DRUG NAME Shigru
FAMILY Moringaceae
LATIN NAME MoringaOleifera
RASA Katu, Tikta
VIRYA Ushna
VIPAKA Katu
Guna Laghu-Ruksha, Tikshna
DOSHA KARMA KaphaVata Shaman
UPYUKTA ANGA Mooltwak , Beej
PROPERTIES Ashmaribhedana, Mootrakrichrahar, VrikkaVikar

Standard Operative Procedures-

1. Shigrumoolwill be collected from authentic source.

2. The formulation will be prepared in the Pharmacy of S.S.A.M. by method,

mentioned in SharangdharSamhita for preparation ofShigrumoolVati

3. The standardised and authenticated drug will be taken for trial.

4. Standard Operating Procedure (S.O.P.) will be followed for the preparation

of ShigrumoolVati.ShigruMool powder will be sieved through mesh 120
size sieve.

5. This Shigrumoolchurna will be taken into khalvayantra to form uniform and

fine paste.this paste is shifted in to drier for drying. After sufficient drying,
granulation process is carried out using binder Acacia Arabica. Finally tablets
are prepared by using Single Rotary Tablet Machine to form 500mg tablets

6. Place of work

All patients of mootrashmari from I.P.D. an O.P.D. department of

Shalyatantra in hospital.

Gokshur Churna-

..

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 Gokshur
SYNONYMS : Swadukantak , Trikantak , Shwadanshtra
FAMILY : Zygophyllaceae
BOTANICAL NAME : Tribulus terrestris Linn.
RASA : Madhur
VIRYA : Sheet
VIPAK : Madhur
DOSH KARMA : Kapha Vata Shamak
GUNA : Guru , Snigdha
PROPERTIES : Mootrakrichrahar , Ashmarihar , Mootral
UPYUKTANGA : Mool, Phala
B) Clinical Study-

StudyDesign
Sample of 30 patients having symptoms of Mootrashmari will be selected
irrespective of gender.
( Through Ayurved Rugnapariksha, Clinical Examination and
Investigation.)

GROUP A Group B

15 patients 15 patients
will receive Shigrumool Vati will receive Gokshur churna

Concomitant treatment will be continuing for 30 days.

Written informed valid consent of patient will be taken

(prior trial)

Follow up for 0 day,15th,30th day will be taken.

Based on observation , comparison of shigrummol vati and Gokshur churna

in Mootrashmari will be done

Conclusions

Result

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 Selection Criteria-
1. Random sampling of 30 cases of MOOTRASHMARI will be selected
2. Age18 years to 60yrs of age irrespective of gender, socio economical
conditions, any systemic diseases.
3. Concomitant therapy (Antihypertensive, hypoglycaemic) will be continued.
Written valid consent of patient will be taken prior to study.

Inclusion criteria-
1. Size of calculus- A known diagnosed case of Urolithiasis having calculus
size up to 6 to 8mm in Ultra Sonography.

2. Site of calculus Ureter , Renal (Upper Pole and Mid Pole Calculus)

3. Age group -18 to 60 years with irrespective of gender.

4. Patient of S/S udarshool (pain in abdomen), sadahamootrapravrutti

(burning micturition), saraktamootrapravrutti (presence of RBCs in urine)
should be included.

5. Patients are having Mild to Moderate Hydronephrosis.

Exclusion Criteria-
1. Systemic diseases like malignancy, Kochs, HIV infected patients and
medico - renal disease (M.R.D.) patient.

2. Renal failure, congenital disorder like ectopic kidney, horse shoe kidney,
neoplasm.

3. Size of calculus >8mm.

4. Site Urinary Bladder , Lower Pole Of Kidney

Patients having severe Hydronephrosis / more than mild to moderate i.e. Grade 4
of Hydronephrosis

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 SAMPLE SIZE FORMULA:-
08) Research
Methodology Prevalence of patients in shalya tantra OPD & IPD.
specified & explained
for data collection n= Z2x P x( 1- P )

d2

Z= 1.96= Standard normal variable

P= 0.02 =Prevalence

d=0.05=error.
according to this formula we have selected 30 patients

Baseline Screening for Selection of patient

Simple randomised selection of 30 patients will be selected irrespective of gender.
Presenting with symptoms of Mootrashmari from OPD and IPD Shalyatantra Dept.
in hospital.

GROUP - A Trial Group

15 patients will receive Shigrumoolvati

GROUP B Control Group

15 patients will receive Gokshur Churna

Drug Shigrumool vati Gokshur Churna

Route of administration Oral Oral

Dose 500 mg 1 tablet BD 5 gm in TDS Dose

Aushadhisevan kala Pragbhakta Pragbhakta

Duration 30 days 30 days

Koshna Jal Koshna Jal

Anupan

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 STATISTICAL TEST-

Statistical analysis will be done by applying Z Test and Wilcoxon Signed

Rank Test

Data will be analysed using non parametric test and investigation byAppropriate
test.

Observation
Sr.No. Sign and Symptoms Follow up
Day 0 Day15TH Day 30TH
1 Udarshoola ( site & intensity)
2 SadahmootraPravrutti
3 SaraktaMootraPravrutti
4 Site of Ashmari(Ureter)
5 Number of Ashmari -

(4) Site of Ashmari and (5) number of Ashmari will be observed on

only day 0,15& 30th day follow up.

Discussion-
Any drawbacks presented during research will also be discussed.
Discussion will be made according to observation noted.

Conclusion
Clinical conclusion will be drawn from the analysed data.
Summary-
The whole work conducted in this study will be summarized in proper manner.

TREATMENT:

Rescue Treatment : If there is increase in number of Pus cells & RBCs in urine
then proper antibiotic will be given as per severity.

UPASHAYANUPSHAYA:

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 Observation

Sr.No Sign and Symptoms Follow up

Day 0 Day 15 Day 30

1 Udarshoola ( site & intensity)

2 Sadahmootrapravrutti

3 Saraktamootrapravrutti

4 Site of Ashmari (Ureter, Renal -

upper pole and mid pole )
5 Number of ashmari -

4)site ofashmari and (5) number of ashmari will be observed on only day 0 and
15th day 30 th follow up .

1. Vd. Ambikadattashastri, Sushrutasamhita, chaukhamba Sanskrit

09) Reference Style :-
sansthan, Varanasi, 9th2009.

2. AcharyaVidyadharShukla ,Prof.RaviDattaTripathiCharakSamhita

Chaukhamba Sanskrit Pratishthan Delhi 2012.

3. VyakhyakarPanditHariprasadTripati, VangasenSamhita, Chaukhamba
Sanskrit series office, Varanasi, 2009.

4. Acharyashriradhakrishnaparashar,Sharangdharasamhita,
baidyanathaAyuervedbhavan, Nagpur, 4th 1994.

5. Vd. Siddhi nandanmishra, Bhaishajyaratnawali,

chaukhambasubhartiprakashan, Varanasi, 1st 2005.

6. Priyavat Sharma, Dravyagunvidnyan, chaukhambabhartiakadami,

Varanasi, 17th 1976

7. Raj NighantuPanditNarhariKrishnadas Academy Varanashi 1982

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 8. S. DAS, A CONCISE TEXTBOOK OF SURGERY, S.DAS

CULCUTTA 4TH 2005.

ANNEXURE- 1
10) Annexures :-
CASE RECORD FORM FOR M.S. (AYU) DISSERTATION
DEPARTMENT OF SHALYATANTRA
CASE PAPER
NAME :
ADDRESS :
GENDER : AGE:
OCCUPATION : TEL/MOBILE NO.
RELIGION : MARIETAL STATUS
OPD/IPD NO : SERIAL NO.
EDUCATION :
DATE OF ADMISSION: DATE OF DISCHARGE:
DATE OF COUNSILING :
CHIEF COMPLAINTS & DURATION:

PAST MEDICAL HISTORY:

DRUG HISTORY:
GYNACOLOGICAL /OBSTRATICAL HISTORY :
SAMAMYA PARIKSHANA:
NADI:
RAKTADABA:
JIVHA:
KSHUDHA :
MALA:
MUTRA:
NAKHA:
AKRUTI:
STROTAS PARIKSHAN:
INVESTIGATIONS

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 ANNEXURE 2

INFORMED CONSENT FORM (ICF)

COMPARITIVE CONTROLLED CLINICAL STUDY TO EVALUATE THE

EFFICACY OF SHIGRUMOOL VATI AND GOKSHUR CHURNA IN THE
MANAGEMENT OF MOOTRASHMARI (UROLITHIASIS).

Subjects Identifier: Subjects Name:

Date of Birth / Age: Gender:

I _____________________________________, age___________ years, exercising my free

power of choice, hereby give my consent to be included as a participant in the clinical study
entitled:

COMPARITIVE CONTROLLED CLINICAL STUDY TO EVALUATE THE

EFFICACY OF SHIGRUMOOL VATI AND GOKSHUR CHURNA IN THE
MANAGEMENT OF MOOTRASHMARI (UROLITHIASIS).

(Please tick in the adjoining box if you agree to the following)

I confirm that I have read/ have been read and understood the information sheet for the [
above study and have had the opportunity to ask questions

I understand that my participation in the study is voluntary and that I am free to withdraw at [
any time, without giving any reason, without my medical care or legal rights being affected.

I understand that the Ethics Committee members, investigators and study doctors will not [
need my permission to look at my health records both in respect of the current study and
any further research that may be conducted in relation to it, even if I withdraw from the trial.
I agree to his access. However, I understand that my identity will not be revealed in any
information released to third parties or published.
I agree not to restrict the use of any data or results that arise from this study provided such [
a use only for scientific purpose(s).

I agree to take part in the above study. [

Name&Signature of of the patient with Date-

Name&Signature of of the student with Date-

Name&Signature of of the Guide with Date-

Witness-

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 ANNEXURE 2.1

CONSENT FORM

:
COMPARITIVE CONTROLLED CLINICAL STUDY TO EVALUATE THE
EFFICACY OF SHIGRUMOOL VATI AND GOKSHUR CHURNA IN THE
MANAGEMENT OF MOOTRASHMARI (UROLITHIASIS).

:Dr.D.G.I.P.G.S.&R.I.A. of S.S.A.M., Hadapsar, Pune.

:
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 ANNEXURE 2.2

ahqWimM

Aprxc vwM :

COMPARITIVE CONTROLLED CLINICAL STUDY TO EVALUATE THE

EFFICACY OF SHIGRUMOOL VATI AND GOKSHUR CHURNA IN THE
MANAGEMENT OF MOOTRASHMARI (UROLITHIASIS).

1) xSU xzkl mMsm qkr Amsrs imxh Ml

cMix Shri rhU AW.

2) xSU urkc cMix qWhl Amhx

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Shri rhU AW.

3) xSU Awk Amhx xMV u xkrMV (- )/

( )Ax 30 Sux
.

4) r mcUliU MW x fsrx Mu CiU x ehusrx iuUi xmM xku.

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 ANNEXURE 3

Abbrevations:
.. -
. . . . -
. . -
. . -

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 ANNEXURE 4

Assessment criteria-

Sr.no Signs and symptoms Assesment

criterias
1 Udarshool (Pain in Abdomen site & intensity) 1 to 10
As per visual analogue scale (V.A.S.)
2 SadahaMootrapravrutti (Burning Micturation)
As per visual analogue scale (V.A.S.)
3 SaraktaMootraPravrutti In numbers
(Presence of RBCs in Urine)

4 Size of Ashmari 6-8 mms

5 Numbers of Ashmari In numbers

6 Site of Ashmari Gavinigat ,

Vrikkagat

Visual Analogue Scale

GRADATION ACCORDING TO PUS CELL IN URINE

Drug Regimen-
Sr.no Grade Stage Pus cells in urine
1 0 None None
2 Mild 6-15
1-4
3 Moderate 15-30
5-7
4 Severe Plenty of pus cell
8-10

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 ABDOMINAL PAIN-
Sr.no Grade Stage Pain

1 0 None No pain

2 1-4 Mild Pain Mild dull pain on&off thrice a

day
3 5-7 Moderate Paine more than thrice a
Pain day
4 8-10 Sever e pain Pain in continuous manner.

Gradations according to R.B.C.S present in Urine-

Sr. No Grade Stage R.B.C.s in Urine

1 0 None 0

2 1-4 Mild 5-15

3 5-7 Moderate 15-30

4 8-10 Severe More than 30

INVESTIGATIONS:

INVESTIGATION Before treatment After treatment

Urine routine

U.S.G.(abdomen & pelvis)

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 ANNEXURE 5

DOCUMENTATION OF INFORMED CONSENT

TITLE OF THE PROJECT COMPARITIVE CONTROLLED CLINICAL STUDY

TO EVALUATE THE EFFICACY OF SHIGRUMOOL VATI AND GOKSHUR
CHURNA IN THE MANAGEMENT OF MOOTRASHMARI (UROLITHIASIS).

I have read the above information and have an opportunity to ask any
question and all my questions have been answered.
I consent to take the medication called SHIGRUMOOL VATI / GOKSHUR CHURNA
I fully understand that it is used in humans & its safety & effectiveness have been fully
established.

I have been given a copy of this consent form.

sName-

Signature-

I,the undersigned have fully explained in local language the relevant

of this trial to the patient named above and / or the person authorized to take the consent for
patient.

I am qualified to perform this role.

Signature-

Date-

Witness-

Signature-

Relationship with the subject-

Address of witness-

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