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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  
SDMCAH Hassan 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition:K802||Calculus of gallbladder without cholecystitis. Ayurveda Condition: other,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(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
2Intervention ArmDrugClassical(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.

 
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