| CTRI Number |
CTRI/2026/04/108735 [Registered on: 20/04/2026] Trial Registered Prospectively |
| Last Modified On: |
20/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Study on the Effect of Haritakyadi Kwatha in the Treatment of Kidney Stones |
|
Scientific Title of Study
|
Randomized Open Controlled Clinical Trial to Evaluate the Efficacy of Haritakyadi Kwatha 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 |
SUJIT HARIBHAU JADHAV |
| Designation |
PG SCHOLAR |
| Affiliation |
Yashwant Ayurved College Post Graduate training Institute And Research Centre, Kodoli |
| Address |
OPD NO 4 Shalya Tantra Department Yashwant Ayurved College Post Graduate and Research Centre Kodoli Kolhapur Maharashtra
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7387166415 |
| Fax |
|
| Email |
sujitjadhav2608@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaibhav Magar |
| Designation |
PG GUIDE |
| Affiliation |
Yashwant Ayurved College Post Graduate training Institute And Research Centre, Kodoli |
| Address |
OPD NO 4 Shalya Tantra Department Yashwant Ayurved College Post Graduate and Research Centre Kodoli Kolhapur Maharashtra
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
8600667796 |
| Fax |
|
| Email |
dr.vaibhav83magar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SUJIT HARIBHAU JADHAV |
| Designation |
PG SCHOLAR |
| Affiliation |
Yashwant Ayurved College Post Graduate training Institute And Research Centre, Kodoli |
| Address |
OPD NO 4 Shalya Tantra Department Yashwant Ayurved College Post Graduate and Research Centre Kodoli Kolhapur Maharashtra
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7387166415 |
| Fax |
|
| Email |
sujitjadhav2608@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant ayurvedic college post graduate training and reserch centre ,kodoli |
|
|
Primary Sponsor
|
| Name |
Dr sujit haribhau jadhav |
| Address |
OPD No 4 Shalyatantra Department Yashwant Ayurvedic College Post Graduate Training And Reaserch Centre Kodoli India 416114 |
| 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 sujit haribhau jadhav |
Yashwant Dharmartha Rugnalaya Kodoli, Tal Panhala |
OPD No 4 Shalyatantra department 3rd floor Yashwant Ayurvedic College Post Graduate and Research Center.
Kolhapur
MAHARASHTRA |
7387166415
sujitjadhav2608@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe 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:O||Medical and Surgical. Ayurveda Condition: MUTRAVAHASROTOVIKARAH, (2) ICD-10 Condition:O||Medical and Surgical. Ayurveda Condition: MUTRAVAHASROTOVIKARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Haritakyadi Kwatha, Reference: Yogatarangini 50/10, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: Water), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shwadanstradi Kwatha , Reference: Vangasen Samhita Vol 1 , Ashmari Rogadhikar 67, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -Water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. USG diagnosed size of calculus equal or less than 8 mm present in KUB at any site will be taken .
2. patient having less than 3 stones in urinary system.
3. age group of 18 to 60 years.
4. patients will be selected irrespective of gender,religion ,occupation ,marital status. |
|
| ExclusionCriteria |
| Details |
1. Congenital anomalies of Kidney.
2. The pregnant women.
3. Patients who are suffering from Severe systemic disorders like Renal failure, Carcinoma.
4. Urethral calculus
5. BPH
6. Shukrashmari
7. Patient required surgical intervention.
8. K/C/O – DM, HTN, HbsAg, TB. |
|
|
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 |
| To study the effect of Haritakyadi Kwatha in Mutrashmari w.s.r. to Urolithiasis in 21 day period |
21 days period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess the effect of Haritakyadi kwatha on the sign and symptoms of mutrashmari with special reference to urolithiasis.
2. To study the mode of action of Haritakyadi Kwatha and Shwadanstradi Kwatha.
3. To achive the outcome of study within 21 days. |
21 days |
|
|
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)
|
06/05/2026 |
| 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="0" |
|
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
|
This study is Randomized open controlled clinical trial to evaluate the efficacy of Haritakyadi Kwatha in mutrashmari with special reference to urolithiasis . this study will be carried out in OPD of shalyatantra department of yashwant ayurvedic college and hospital ,kodoli ,kolhapur. observations will be drawn on the basis of symptoms after treatment given . |