| CTRI Number |
CTRI/2026/02/104231 [Registered on: 18/02/2026] Trial Registered Prospectively |
| Last Modified On: |
18/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study on efficacy of Kulattha ghana vati in Mutrashmari (Urolithiasis) f0r age group of 25-50 years, for 30 days |
|
Scientific Title of Study
|
Efficacy of Kulattha ghana vati in comparison to Gokshuradi guggulu in Mutrashmari-Urolithiasis
- A Randomised clinical study
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Soundarya Shrishail Biradar |
| Designation |
Post Graduation scholar, Department of Shalya Tantra |
| Affiliation |
Sri Dharmasthala manjunatheshwara institute of Ayurveda and Hospital, Anchepalya, Kumbalagodu post , Bangalore |
| Address |
Sri Dharmasthala Manjunatheswara institute of Ayurveda and Hospital, Bengaluru, Karnataka 560074
Bangalore
KARNATAKA
560074
India |
| Phone |
9743191707 |
| Fax |
|
| Email |
soundaryabiradar1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bharati D Anvekar |
| Designation |
Professor, Department of Shalya Tantra |
| Affiliation |
Sri Dharmasthala manjunatheshwara institute of Ayurveda and Hospital, Anchepalya, Kumbalagodu post, Bangalore |
| Address |
Sri Dharmasthala Manjunatheswara institute of Ayurveda and Hospital, Bengaluru, Karnataka 560074
Bangalore
KARNATAKA
560074
India |
| Phone |
9886410690 |
| Fax |
|
| Email |
bharathisanjeev@sdmayurbangalore.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Soundarya Shrishail Biradar |
| Designation |
Post Graduation scholar, Department of Shalya Tantra |
| Affiliation |
Sri Dharmasthala manjunatheshwara Institute of Ayurveda and Hospital, Anchepalya, Kumbalagodu post , Bangalore |
| Address |
Sri Dharmasthala Manjunatheswara institute of Ayurveda and Hospital, Bengaluru, Karnataka 560074
Bangalore
KARNATAKA
560074
India |
| Phone |
9743191707 |
| Fax |
|
| Email |
soundaryabiradar1999@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Anchepalya, Kumbalagodu post, Bangalore- 560074, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Dr Soundarya Shrishail Biradar |
| Address |
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Anchepalya, Kumbalagodu post, Bangalore- 560074, Karnataka, India |
| 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 |
| Dr Soundarya Shrishail Biradar |
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Bangalore |
Department of Shalya Tantra,
OPD number - 16,18,19,20,21
Bangalore
KARNATAKA |
9743191707
soundaryabiradar1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Anchepalya, Kumbalagodu Post, Bangalore - 560074, Karnataka, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N21||Calculus of lower urinary tract. Ayurveda Condition: MUTRAVAHASROTOVIKARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kulattha ghana vati, Reference: Bhavaprakasha nighantu, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -jala), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Gokshuradi guggulu, Reference: Ayurveda formulary of India, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1)Asymptomatic subjects who will be diagnosed with urolithiasis, detected accidentally by
USG of Abdomen and pelvis. 2) Irrespective of gender, Socioeconomic status, religion and place. 3) Subjects aged between 25 - 50 yrs. 4) Subjects with solitary or multiple calculi. 5) Stone location - Kidney, ureter and bladder. 6) Size of stone within 10 days |
|
| ExclusionCriteria |
| Details |
1) Subjects suffering from Chronic kidney diseases. 2) Pregnant and Lactating mother. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Reduction in the size of Mutrashmari. |
0th day(baseline), 15th day and 30 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in the Symptoms of patients like pain in abdomen /flank, haemeturia, Dysuria , UTIs |
0th day(baseline), 15th day & 30th day |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/03/2026 |
| 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="7" |
|
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
|
A randomised clinical study on the efficacy of Kulattha ghana vati in Mutrashmari (Urolithiasis) in age group of 25 to 50 years for a period of 30 days. During this study period 30 subjects diagnosed with Mutrashmari (Urolithiasis) will be recruited and divided into two groups, Group A (Trial drug / Intervention drug) and Group B (Control drug / Comparator drug) 15 subjects in each group respectively. Group A includes 15 subjects qualifying inclusion criteria of the current study will be administered Kulattha ghana vati internaly in the dose of 500 mg twice a day before food followed by jalapana and assessment of the patient during trial on 0th day, 15th day and 30th day. Group B includes 15 subjects qualifying inclusion criteria of the current study will be administered Gokshuradi guggulu internaly in the dose of 500 mg twice a day before food followed by jalapana and assessment of the patient during trial on 0th day, 15th day and 30th day. The outcome measures will be significant improvement noticed in Mutrashmari (Urolithiasis) after 30 days. Statistical analysis will be done through data obtained based on before and after treatment assessment. |