| CTRI Number |
CTRI/2020/01/022777 [Registered on: 15/01/2020] Trial Registered Prospectively |
| Last Modified On: |
10/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
ROLE OF GOKSHUR SWARN MAKSHIK YOGA AND GOKSHUR CHURNA IN THE TREATMENT OF KIDNEY STONE |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFECT OF GOKSHUR SWARN MAKSHIK YOGA AND GOKSHUR CHURNA IN THE MANAGEMENT OF MOOTRAASHMARI WITH SPECIAL REFERENCE NEPHROLITHIASIS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chandrabhan Singh Gurjar |
| Designation |
PG Scholar |
| Affiliation |
parul institute of ayurveda |
| Address |
parul ayurved hospital p.o limda parul university
Vadodara
Vadodara
GUJARAT
391670
India |
| Phone |
7509963879 |
| Fax |
|
| Email |
chandu.gurjar420@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hemant D Toshikhane |
| Designation |
Professor |
| Affiliation |
parul institute of ayurveda |
| Address |
parul ayurved hospital p.o limda parul university
Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
8469496525 |
| Fax |
|
| Email |
drhemantt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chandrabhan Singh Gurjar |
| Designation |
PG Scholar |
| Affiliation |
parul institute of ayurveda |
| Address |
parul ayurved hospital p.o limda parul university
Vadodara
Vadodara
GUJARAT
391670
India |
| Phone |
7509963879 |
| Fax |
|
| Email |
chandu.gurjar420@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
parul institute of ayurveda |
| Address |
parul ayurved hospital p.o limda parul university
Vadodara
|
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Chandrabhan Singh Gurjar |
parul ayurveda hospital |
Department of Shalya Tantra OPD/IPD No. 116 Limda Vadodara Gujarat 391760
Vadodara
GUJARAT |
7509963879
chandu.gurjar420@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee for human research. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N200||Calculus of kidney, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Gokshur Churna in mootraashmari |
Dose -(18 - 60 years) -5 gm Gokhur churna twice daily with luke warm water
Route of Administration - Orally
Duration of Treatment -30 days |
| Intervention |
Gokshur Swarn Makshik Yoga in Mootraashmari |
Dose-(Age 18-60 year) 4gm Gokhur churna + 125 mg swarnmakshika bhasma twice daily with Mahish dugdh
Route Of administration - Orally
Duration of teatment -30 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients having classical signs and symptoms of mootraashmari
2. Patient with the size of calculus 8mm or less than 8mm
3. Patients with unilateral and bilateral renal calculi |
|
| ExclusionCriteria |
| Details |
1. Patient having renal calculus of size more than 8mm
2. Patient having grade 2 and above hydronephrosis
3. Chronic systemic illness, HIV, malignancy and other renal tract disease
4. Congenital anomalies of urinary system
5. Infective condition of kidney |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Gokshura Swarnmakshik Yoga will be more effective than Gokshur Churna in the management of mootrashmari |
30 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
20/01/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
1.Ashmari has been Explained in ayurvedic classic as a kaphapradoshajvyadhi and also as one of the mahagada. 2.Ashmari is one of the most common disorders of the Mutravahasrotas. 3. All Aacharya has been described about ashmari but Aachrya sushruta has described in detail about ashmari . 4.Different management of ashmari has been devloped in moderen system but in spite of all these techniques,surgery remain chioce of treatment. (ESWL,PCNL and URS). 5.So there is a need to find out an alternative cost effective,affordable and easily avaiable management of urinary disease. 6.In ayurvedic classics several reference are avaailable regarding ashmari chikitsa. |