| CTRI Number |
CTRI/2020/08/027073 [Registered on: 10/08/2020] Trial Registered Prospectively |
| Last Modified On: |
08/08/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of Brihat Varunadi Kwath with Shveta Parpati in renal calculus. |
|
Scientific Title of Study
|
Clinico-Anatomical Study of Mootravaha Srotas in Mootrashmari w.s.r. to therapeutic effect of Brihat Varunadi kwatha & Shveta Parpati |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Suljeet Baranda |
| Designation |
MD Scholar, Department of Rachana Sharir |
| Affiliation |
University College of Ayurved Jodhpur |
| Address |
Room no.53,PG Department of Rachana Sharir, University College of Ayurveda, Dr. Sarvepalli Radhakrishnan rajasthan Ayurved University, Jodhpur-342037
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9602319146 |
| Fax |
|
| Email |
suljeetbaranda1993@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakesh Kumar Sharma |
| Designation |
Associate Professor |
| Affiliation |
University College of Ayurved Jodhpur |
| Address |
Room no.53, PG Department of Rachana Sharir, University College of Ayurved, Dr. Sarvepalli RadhaKrishnan rajasthan Ayurved University jodhpur-342037
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9166216760 |
| Fax |
|
| Email |
rksharma_jumbo@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Suljeet Baranda |
| Designation |
MD Scholar, Department of Rachana Sharir |
| Affiliation |
University College of Ayurved Jodhpur |
| Address |
Room no.53, PG Department of Rachana Sharir, University College of Ayurved, Dr. Sarvepalli RadhaKrishnan rajasthan Ayurved University jodhpur-342037
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9602319146 |
| Fax |
|
| Email |
suljeetbaranda1993@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no.53, PG Department of Rachana Sharir, University College of Ayurved, Dr. Sarvepalli RadhaKrishnan rajasthan Ayurved University jodhpur-342037 |
|
|
Primary Sponsor
|
| Name |
SULJEET BARANDA |
| Address |
UNIVERSITY COLLEGE OF AYURVEDA JODHPUR |
| Type of Sponsor |
Government 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 Rakesh Kumar Sharma |
Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, University Hospital of Ayurveda Jodhpur |
OPD No.3, PG Department of Kayachikitsa, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Karwar nagaur road Jodhpur
Jodhpur
RAJASTHAN |
9166216760
rksharma_jumbo@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC University College of Ayurved, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N22||Calculus of urinary tract in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Brihat Varunadi Kwath & Shveta Parpati |
Brihat Varunadi Kwath-30 ml. and Shveta Parpati-250 mg BD Orally for 1 months |
| Comparator Agent |
Hospital medicine by doctors to patients in IPD/OPD of Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, University Hospital of Ayurveda Jodhpur |
Doctors will give his prescription Medicine for 1 months |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Clinically and pathologically diagnosed patients of all types of Mootrashmaris.Size of calculus should not be less than 10 mm.
|
|
| ExclusionCriteria |
| Details |
Patients of Benign Prostatic Hyperplasia,Renal failure, renal tuberculosis, diabetes mellitus, Multiple urinary stones and suffering from any other systemic disorder.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in subjective and objective parameter |
Follow up at 15 day Interval |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find out the efficacy of treatment |
1 month |
|
|
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
10/08/2020 |
| 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="0"
Months="9"
Days="5" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
this is a random parallel group trial of patient suffering from calculus of urinary tract. in one group patient will be given 20 ml. brihat varunadi kwatha and mix with 250 mg. shveta parpati twice in a day. in other group patient will be given by doctors prescription in hospital opd/ipd of DSRRAU jodhpur. and compare the result of both groups. |