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CTRI Number  CTRI/2026/03/105172 [Registered on: 02/03/2026] Trial Registered Prospectively
Last Modified On: 28/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Study to Compare the Effect of Anandbhairavi Vati and Varunadi Kashaya in the Treatment of Urinary Stones 
Scientific Title of Study   A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF ANANDBHAIRAVI VATI & VARUNADI KASHAYA IN THE MANAGEMENT OF MUTRASHMARI W.S.R TO UROLITHIASIS 
Trial Acronym  STONE-AYU 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Najeeb TK 
Designation  Professor  
Affiliation  Shri Babu SIngh Jay Singh Ayurvedic Medical College And Hospital Farrukhabad 
Address  Doctors Residence Department of PG Studies in Shalya Tantra Shri Babu Singh Jay Singh Ayurvedic Medical College Farrukhabad Uttar Pradesh 209602

Farrukhabad
UTTAR PRADESH
209602
India 
Phone  9947873825  
Fax    
Email  drnajeebtk@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Najeeb TK 
Designation  Professor  
Affiliation  Shri Babu SIngh Jay Singh Ayurvedic Medical College And Hospital Farrukhabad 
Address  Doctors Residence Department of PG Studies in Shalya Tantra Shri Babu Singh Jay Singh Ayurvedic Medical College Farrukhabad Uttar Pradesh 209602

Farrukhabad
UTTAR PRADESH
209602
India 
Phone  9947873825  
Fax    
Email  drnajeebtk@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Najeeb TK 
Designation  Professor  
Affiliation  Shri Babu SIngh Jay Singh Ayurvedic Medical College And Hospital Farrukhabad 
Address  Doctors Residence Department of PG Studies in Shalya Tantra Shri Babu Singh Jay Singh Ayurvedic Medical College Farrukhabad Uttar Pradesh 209602

Farrukhabad
UTTAR PRADESH
209602
India 
Phone  9947873825  
Fax    
Email  drnajeebtk@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Self 
Address  Shri Babu Singh Jay Singh Ayurvedic Medical College And Hospital Farrukhabad Uttar Pradesh 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR ARUN KUMAR  SHRI BABU SINGH JAY SINGH AYURVEDIC MEDICAL COLLEGE AND HOSPITAL FARRUKHABAD UTTAR PRADESH  Department of Shalya Tantra second floor Room No 215
Farrukhabad
UTTAR PRADESH 		 8057270644

arunkushwaha622@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N200||Calculus of kidney. Ayurveda Condition: MUTRAVAHASROTOVIKARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Anandbhairavi Vati, Reference: Brihad Nighantu Ratnakar, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Ushna jala ), Additional Information: -
(2) Medicine Name: Varunadi Kashaya , Reference: Sharangdhar Samhita, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Ushna Jala), Additional Information: -
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with specific Lakshanas of Mutrashmari will be included in the present study.
The patients between the age group of 16-60 years will be selected irrespective of sex, occupation, race, chronicity and socio- economic status.
Patient having Calculi measuring up to 10 mm will be included for the present study.
 
 
ExclusionCriteria 
Details  Patients who are suffering with severe systemic disorders like renal failure, tuberculosis, congenital disorders and neoplasm will be excluded.
Acute urinary obstructive conditions will be excluded.
When stone is obstructed in the natural constrictions of the ureter.
 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in size of urinary calculus (USG / X-ray KUB)  30 DAYS 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in severity of Mutrashmari symptoms (pain, dysuria, frequency of micturition)  Baseline, Day 15, and Day 30 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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   N/A 
Date of First Enrollment (India)   15/03/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  15/03/2026 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="8"
Days="30" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   Mutrashmari (urolithiasis) is a common urinary disorder characterized by the formation of calculi in the urinary tract, leading to pain, dysuria, and other urinary symptoms. Ayurveda describes Mutrashmari as one of the Ashta Mahagada. Anandbhairavi Vati and Varunadi Kashaya are classical Ayurvedic formulations indicated in the management of Mutrashmari. The present study is planned to evaluate and compare the efficacy of Anandbhairavi Vati and Varunadi Kashaya in the management of Mutrashmari with special reference to urolithiasis. This will be an interventional, randomized, open-label, parallel-group, active-controlled clinical trial conducted on patients diagnosed with urolithiasis. The outcome will be assessed based on reduction in size of urinary calculus and improvement in clinical symptoms. 
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