| CTRI Number |
CTRI/2026/02/103695 [Registered on: 12/02/2026] Trial Registered Prospectively |
| Last Modified On: |
03/02/2026 |
| 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 Randomized study Comparing Herbal and Modern Medicine in Treatment of Gall Stones |
|
Scientific Title of Study
|
Comparative Evaluation of Efficacy of the Kokilaksha Arka and Ursodeoxycholic Acid in Cholelithiasis:A Randomized Controlled Trial. |
| 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 Sunny Shivshankar Patel |
| Designation |
PG Scholar Shalyatantra |
| Affiliation |
Dr D Y Patil College of Ayurved and Research Center |
| Address |
OPD 3 and Shalyatantra IPD, Dr D Y Patil College of Ayurved and Research Center, Sant Tukaram Nagar, Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
07977639353 |
| Fax |
|
| Email |
drsunnypatel1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay C Babar |
| Designation |
MS, PhD (Shalyatantra) |
| Affiliation |
Dr D Y Patil College of Ayurved and Research Center |
| Address |
OPD 3 and Shalyatantra IPD, Dr D Y Patil College of Ayurved and Research Center, Sant Tukaram Nagar, Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9011035602 |
| Fax |
|
| Email |
sanjaybabar14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay C Babar |
| Designation |
MS, PhD (Shalyatantra) |
| Affiliation |
Dr D Y Patil College of Ayurved and Research Center |
| Address |
OPD 3 and Shalyatantra IPD, Dr D Y Patil College of Ayurved and Research Center, Sant Tukaram Nagar, Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9011035602 |
| Fax |
|
| Email |
sanjaybabar14@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil College of Ayurved and Research Center Sant Tukaram Nagar Pimpri Pune |
|
|
Primary Sponsor
|
| Name |
Dr Sunny Shivshankar Patel |
| Address |
Dr D Y Patil College of Ayurved and Research Center Sant Tukaram Nagar Pimpri Pune Maharashtra India 411018 |
| 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 Sunny Shivshankar Patel |
Dr D Y Patil college of Ayurveda and Research Center Pune |
OPD No 3 And IPD Shalyatantra of Dr D Y Patil College of Ayurved and Research Center Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA |
07977639353
drsunnypatel1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR DYPCA AND RC Institutional Ethics Commettee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K802||Calculus of gallbladder without cholecystitis. Ayurveda Condition: pitta, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kokilaksha Arka , Reference: Bhavprakash Nighandu/Guduchiyadivarga shlok no 224/225, Ravan samhita ,atharkprakash adhyay:4,shlok:15, Route: Oral, Dosage Form: Arka, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: Equal Amount of Water), Additional Information: | | 2 | Comparator Arm (Non Ayurveda) | | - | Ursodeoxycholic Acid | 1 tablet twice a day with water for 21 days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
confirmed diagnosis of cholelithiasis (via ultrasound)
patient having one or multiple stone size less than 8mm, with and without symptoms
associated symptoms:pain in right upper abdomen, nausea, vomiting |
|
| ExclusionCriteria |
| Details |
acute cholecystitis or biliary obstruction with severe abdominal pain, fever, jaundice which requires immediate surgical management
large or impacted gallstones more than 08mm of size
pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in gallstone size or number (via USG) |
00day, 07day, 14day, 21day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in Pain (VAS)
Improvement in appetite, digestion, bowel habits |
on completion of treatment |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
02/03/2026 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
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
|
Comparative Evaluation of Efficacy of the Kokilaksha Arka and Ursodeoxycholic Acid in Cholelithiasis: A Randomized Controlled Trial |