| CTRI Number |
CTRI/2022/03/040976 [Registered on: 10/03/2022] Trial Registered Prospectively |
| Last Modified On: |
09/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
varunadi churna in renal stone |
|
Scientific Title of Study
|
Randomised open controlled clinical study to evaluate the efficacy of varunadi churna in mutrashmari with special reference to urolithiasis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shahal Yuvraj Bhosale |
| Designation |
PG scholar |
| Affiliation |
Yashwant Ayurvedic Medical College PGT and RC kodoli |
| Address |
Yashwant Ayurvedic Medical College PGT and RC kodoli.
shalyatantra department
opd no.4
Yashwant Ayurvedic Medical College PGT and RC kodoli
Kolhapur
MAHARASHTRA
416012
India |
| Phone |
9673325911 |
| Fax |
|
| Email |
shahal28b@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR T SRINIVAS |
| Designation |
PG GUIDE / HOD shalyatantra department |
| Affiliation |
Yashwant Ayurvedic Medical College PGT and RC kodoli |
| Address |
Yashwant Ayurvedic Medical College PGT and RC kodoli
shalyatantra department opd no 4
Yashwant Ayurvedic Medical College PGT and RC kodoli
Kolhapur
MAHARASHTRA
416012
India |
| Phone |
9503147698 |
| Fax |
|
| Email |
drsrinivast@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shahal Yuvraj Bhosale |
| Designation |
PG scholar |
| Affiliation |
Yashwant Ayurvedic Medical College PGT and RC kodoli |
| Address |
Yashwant Ayurvedic Medical College PGT and RC kodoli
Yashwant Ayurvedic Medical College PGT and RC kodoli
Kolhapur
MAHARASHTRA
416012
India |
| Phone |
9673325911 |
| Fax |
|
| Email |
shahal28b@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurvedic Medical College PGT and RC kodoli kolhapur maharashtra |
|
|
Primary Sponsor
|
| Name |
Shahal Yuvraj Bhosale |
| Address |
1697 A ward kedar plaza third floor sakoli corner Kolhapur |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Shahal Yuvraj Bhosale |
Yashwant dharmartha rugnalaya |
Yashwant dharmartha rugnalaya kodoli shalyatantra department opd no 4
Kolhapur
MAHARASHTRA |
9673325911
shahal28b@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Yashwant Ayurvedic college PGT and RC kodoli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N209||Urinary calculus, unspecified. Ayurveda Condition: ASMARI, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Tab outocal |
Tab outocal 500 mg BD for 15 days |
| Intervention |
Varunadi churna |
Varunadi churna 3gm TDS for 15 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Predignosed patient with clinical features and USG showing calclus size 4-8 mm songle or multiple will be taken for treatment
Calclus present in kidney/ureter/bladder |
|
| ExclusionCriteria |
| Details |
Patient who were containdicated for paneeya kshara
Any malignancy
Any systemic disease |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in stone size |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in symptoms like pain burning mituration dysuria |
18 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
20/03/2022 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Data are available indefinitely at (Link to be included shahal28b@gmail.com).
- For how long will this data be available start date provided 01-04-2021 and end date provided 24-12-2022?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The observation would be drawn on the basis of symptoms after treatment given |