| CTRI Number |
CTRI/2025/12/099165 [Registered on: 16/12/2025] Trial Registered Prospectively |
| Last Modified On: |
16/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Management of Cholelithiasis Ayurveda |
|
Scientific Title of Study
|
A Comparative Study to Evaluate the Efficacy of Patolamuladi Kwatha followed by Navasadara and Badarashma in the Management of Cholelithiasis |
| Trial Acronym |
Nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrAmruthagowriY |
| Designation |
Phd Scholar External |
| Affiliation |
Rajiv Gandhi University of Health Sciences Bengaluru Karnataka |
| Address |
SDM College of Ayurveda Hassan
Karnataka. SDM College of Ayurveda and Hospital
BM Road Thanneeruhalla
Hassan Hassan KARNATAKA 573201 India |
| Phone |
8277195986 |
| Fax |
|
| Email |
dramruthagowriy@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Gopikrishna BJ |
| Designation |
Professor and HOD |
| Affiliation |
RGUHS Bengaluru Karnataka |
| Address |
Professor and HOD.
Dept of Shalya Tantra
SDM College of Ayurveda and Hospital
BM Road Thanneeruhalla
Hassan Prof and HOD
Dept of Shalya Tantra
SDMCAH Hassan. Hassan KARNATAKA 573201 India |
| Phone |
9886360901 |
| Fax |
|
| Email |
drgopiboyapati@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Amruthagowri Y |
| Designation |
Phd Scholar External |
| Affiliation |
RGUHS Bengaluru. Karnataka |
| Address |
SDMCAH Hassan Karnataka. SDM College of Ayurveda and Hospital
BM Road Thanneeruhalla
Hassan Hassan KARNATAKA 573201 India |
| Phone |
8277195986 |
| Fax |
|
| Email |
dramruthagowriy@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SDMCAH Hassan |
| Address |
SDMCAH Hassan
Department of Shalya Tantra
Opd and ipd of shalya tantra |
| Type of Sponsor |
Research institution |
|
|
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 Amruthagowri Y |
SDM College of Ayurveda and Hospital |
Dept of Shalya Tantra
OPDs and IPDs of Shalya Tantra Hassan KARNATAKA |
8277195986
dramruthagowriy@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition:K802||Calculus of gallbladder without cholecystitis. Ayurveda Condition: other, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Navasadara or Kitta Kshara, Reference: Rasa Tarangini, Route: Oral, Dosage Form: Churna/ Powder, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Water), Additional Information: -Navasadara is also known as Kitta kshara and Chullika lavana | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Badarashma, Reference: Rasa Tantra sara and Siddha Prayoga Sangraha, Route: Oral, Dosage Form: Bhasma, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Water), Additional Information: -Badarashma Bhasma is also known as Hajurlyahud Bhasma |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects irrespective of sex, given consent from age group 18 to 60 years
Asymptomatic cases
Mild symptomatic without any complications of cholelithiasis.
Subjects with sonographic evidence of gall stones of size less than 15mm diameter
|
|
| ExclusionCriteria |
| Details |
Persons who are contraindicated for Paniya Kshara
Immunocompromised persons uncontrolled systemic diseases like Diabetes mellitus HbA1C more than 8 percent Hypertension
Complicated cases of Cholelithiasis like Cholecystitis Choledocholithiasis Cholangitis
Hereditary haemolytic diseases leading to pigment stones
Subjects with congenital anomalies of hepato biliary system
Subjects with features of liver failure obstructive jaundice Carcinoma gall bladder acute obstructive cholecystitis
Subjects suffering from other systemic disorders and condition which interfere with the treatment and requiring surgical intervention
|
|
|
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
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Size Reduction of Cholelithiasis |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in the Number of stone and Sludge in the gallbladder |
60 days |
|
|
Target Sample Size
|
Total Sample Size="150" Sample Size from India="150"
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 |
|
Date of First Enrollment (India)
|
16/11/2026 |
| 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="5" Months="0" 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
|
Gallstones are the most prevalent issue affecting the biliary system. They impact around 10-15% of the world population, approximately 4% in India with over 80% of those affected experiencing symptoms at some point in their lives, and 1-2% requiring surgery annually. Among them males affected are 6.2% and females are at 7.3%. Asymptomatic gallstones will be monitored, while surgery (cholecystectomy) is reserved for symptomatic cases or those with complications.
Ashmari (caliculi) in Ayurveda mainly focuses on urinary stones with the classification of Dosha predominancy. Pittaja Ashmari pathogenesis can be considered here. Ashmari Bhedana Dravyas (Litholytic and Lithotripsic drugs) have been explained in many Samhitas, Nighantus and Rasa Granthas. Considering the risk of complications by cholelithiasis, limited medical managements available in contemporary systems, necessity for evaluating, updating and validating the ayurvedic treatments; there is a high need for the present clinical study to evaluate the efficacy of Patolamuladi Kwatha followed by Navasadara and Badarashma in the Management of Cholelithiasis. The scientific research for the authentication of these easily available, cost effective and unique combination is highly needed. |