| CTRI Number |
CTRI/2025/09/094860 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
04/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study on ayurvedic intervention in mutrashmari |
|
Scientific Title of Study
|
Clinical evaluation of yava kshar with gokshuradi kashayam in mutrashmari (Renal calculi) |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deeksha Joshi |
| Designation |
MS Scholar |
| Affiliation |
Gurukul Campus Uttarakhand Ayurved University Haridwar |
| Address |
OPD No 7 Department of Shalya Tantra Gurukul Campus Uttarakhand Ayurved University Haridwar
Hardwar
UTTARANCHAL
249404
India |
| Phone |
7060685743 |
| Fax |
|
| Email |
joshideeksha0000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil Kumar Gupta |
| Designation |
Professor |
| Affiliation |
Gurukul Campus Uttarakhand Ayurved University Haridwar |
| Address |
OPD No 7 Department of Shalya Tantra Gurukul Campus Uttarakhand Ayurved University Haridwar
Hardwar
UTTARANCHAL
249404
India |
| Phone |
9997229851 |
| Fax |
|
| Email |
suniljivaidya@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Deeksha Joshi |
| Designation |
MS Scholar |
| Affiliation |
Gurukul Campus Uttarakhand Ayurved University Haridwar |
| Address |
OPD No 7 Department of Shalya Tantra Gurukul Campus Uttarakhand Ayurved University Haridwar
Hardwar
UTTARANCHAL
249404
India |
| Phone |
7060685743 |
| Fax |
|
| Email |
joshideeksha0000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gurukul Campus Uttarakhand Ayurved University Haridwar 249404 |
|
|
Primary Sponsor
|
| Name |
Gurukul Campus Uttarakhand Ayurved University Haridwar |
| Address |
OPD No 7 Department of Shalya Tantra Gurukul Campus Uttarakhand Ayurved University Haridwar 249404 |
| 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 Deeksha Joshi |
Gurukul Campus Uttarakhand Ayurved University Haridwar |
OPD No 7 Department of Shalya tantra Gurukul Campus Uttarakhand Ayurved University Haridwar
Hardwar
UTTARANCHAL |
7060685743
joshideeksha0000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe Uttarakhand Ayurved University Dehradun |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N200||Calculus of kidney. Ayurveda Condition: ASMARI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Yava Kshar, Reference: Rastarangini chapter 13 shlok no. 29- 3-0, Route: Oral, Dosage Form: Kshara , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Gokshuradi kashaya (40 ml bd)), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patient having classical signs and symptoms of Mutrashmari will be included.
2) Patients of both sexes and above age of 18 years to 60 years age, irrespective of religion, socioeconomic status, occupation will be taken.
3) Patient having renal calculi with or without mild hydronephrosis will be selected.
4) Radiological evidence of (upto 8 mm) in kidney. |
|
| ExclusionCriteria |
| Details |
1) Complications related to Kidneys/Ureter/Bladder like- Acute Renal Failure, Chronic Renal Failure, Polycystic Kidney diseases, Impaired Renal function.
2) Patients having systemic diseases like RHD, AIDS (Acquired immune deficiency syndrome).
3) Other chronic diseases like TB (Tuberculosis), Hepatitis etc. will be excluded.
4) Pregnant women and lactating mothers will be excluded.
5) Patients having Moderate or severe Hydronephrosis, stag horn calculi will be excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Reduction in the size of calculi
2) complete expulsion of calculi |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sign and symptoms of mutrashmari will reduce with treatment |
3 months |
|
|
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)
|
30/09/2025 |
| 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="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Mutrashmari is one of the commonest disease of mutravaha Srotas, which is characterised by Pain in nabhi, basti, sevani, mehana, mutradharasangha (obstruction in urine), sarudhiramutrata (Hematuria), mutravikiran (Double stream of urine). Rasatarangini has indicated Yava kshar with Gokshuradi Kashayam as anupara in mutrashmari. This is an open-label, single-arm clinical trial conducted to evaluate the efficacy of Yava Kshara with Gokshuradi Kashaya in the management of Mutrashmari (urinary calculi). Yava Kshara is administered in capsule form at a dose of 1 capsule (500 mg) twice daily, along with 40 ml of Gokshuradi Kashaya as an anupana, taken before meals. The treatment duration is of 3 months, followed by a 1 month of follow-up. A total of 30 patients diagnosed with Mutrashmari is included in the study. The trial is conducted at the Gurukul Campus, Uttarakhand Ayurved University, Haridwar. |