| CTRI Number |
CTRI/2025/10/096000 [Registered on: 13/10/2025] Trial Registered Prospectively |
| Last Modified On: |
09/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing the Effectiveness of Kokilaksha Paneeya Kshara and Yava Paneeya Kshara in Treating Gallstones |
|
Scientific Title of Study
|
A Comparative Clinical Study to Evaluate the Efficacy of Kokilaksha Paneeya Kshara and Yava Paneeya Kshara in the Management of Pittashmari Cholelithiasis |
| 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 Patil Spoorti Gurubasav |
| Designation |
Post Graduate Resident In Shalya Tantra |
| Affiliation |
Dr N A Magadum Ayurvedic Medical College Hospital And Research Centre, Ankali |
| Address |
Dr N A Magadum Ayurvedic Medical College Hospital and Research Center Ankali, Tal-Chikodi
Dist-Belgaum, Karnataka, Shalya Tantra/Surgery OPD no 4
Belgaum
KARNATAKA
591213
India |
| Phone |
7666485635 |
| Fax |
|
| Email |
patilspoorti900@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mrs Shaista R Jamadar |
| Designation |
Associate professor Department of Shalyatantra |
| Affiliation |
Dr N A Magadum Ayurvedic Medical College Hospital And Research Centre, Ankali |
| Address |
Dr N A Magadum Ayurvedic Medical College Hospital and Research Center Ankali, Tal-Chikodi, Dist-Belgaum, Shalya Tantra/Surgery OPD no 4
Belgaum
KARNATAKA
591213
India |
| Phone |
8369311754 |
| Fax |
|
| Email |
rajshaista786@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mrs Shaista R Jamadar |
| Designation |
Associate professor Department of Shalyatantra |
| Affiliation |
Dr N A Magadum Ayurvedic Medical College Hospital And Research Centre, Ankali |
| Address |
Dr N A Magadum Ayurvedic Medical College Hospital and Research center Ankali,Tal-Chikodi,Dist-Belgaum,Karnataka,Shalya Tantra/Surgery OPD no 4
Belgaum
KARNATAKA
591213
India |
| Phone |
8369311754 |
| Fax |
|
| Email |
rajshaista786@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr N A Magadum Ayurvedic Medical College Hospital and Research Center Ankali 591213,Tal-Chikodi,Dist-Belgaum,Karnataka,Shalya Tantra/Surgery OPD no 4 |
|
|
Primary Sponsor
|
| Name |
Dr Patil Spoorti Gurubasav |
| Address |
Dr N A Magadum Ayurvedic Medical College hospital and Research Center Ankali |
| 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 Patil Spoorti Gurubasav |
Dr N A Magadum Ayrvedic Medical college Hospital and Research Center Ankali |
Department of Shalya tantra/Surgery OPD no 4
Belgaum
KARNATAKA |
07666485635
patilspoorti900@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr.NAMAMC-IEC |
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: PITTAJA-ASMARI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kokilaksha Paneeya Kshara, Reference: Bhavaprakasha Nigantu Guduchyadi Varga, Route: Oral, Dosage Form: Kshara , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Patola Katurohinyadi kashayam), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Yava Paneeya Kshara, Reference: Bhavaprakasha Nighantu Dhanya varga, Route: Oral, Dosage Form: Kshara , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Patola Katurohinyadi kashayam), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with the clinical features of Cholelithiasis or silent gallstones And Subjects of either sex and age group between 17-65 years. |
|
| ExclusionCriteria |
| Details |
Patients unfit for Paneeya Kshara, immunocompromised (HIV, Hepatitis B,C), with uncontrolled systemic diseases (DM, HTN), gallstone complications such as cholecystitis, empyema, perforation, mucocele, choledocholithiasis, CBD obstruction, obstructive jaundice, cholangitis, carcinoma, pancreatitis, liver failure, any condition presenting sign of jaundice were excluded.Subjects with congenital hepatobiliary anomalies and hemolytic disorders like sickle cell anemia, thalassemia, malaria, cirrhosis, and hereditary spherocytosis are excluded |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of treatment in reducing the size of gallstones by ultrasonographic assessment before and after 30 days Additionally to assess symptomatic relief including right upper quadrant abdominal pain |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of treatment on symptomatic relief including nausea vomiting flatulence and dyspepsia Additionally to evaluate tenderness |
4 months |
|
|
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)
|
20/10/2025 |
| 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="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
|
The present study title, " A comparative clinical study to evaluate the efficacy of Kokilaksha paneeya kshara and Yava paneeya kshara in the management of Pittashmari (Cholelithiasis)" will be conducted on 40 subjects, with 20 in each group, with the mentioned objective and subjective parameters. One group will be treated with Kokilaksha paneeya kshara, and the other group with Yava paneeya kshara. Assessment of the patient will be done before and after treatment |