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CTRI Number  CTRI/2026/02/103411 [Registered on: 09/02/2026] Trial Registered Prospectively
Last Modified On: 07/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A clinical study to understand the effect of Rohithakadi yogam tablets in patients with cholelithiasis( gall stone) 
Scientific Title of Study   Effectiveness of Rohithakadi yogam in 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  Darsana P S 
Designation  Post Graduate Scholar 
Affiliation  Government Ayurveda College Thiruvananthapuram 
Address  Department of Dravyaguna Vigyana Government Ayurveda College Thiruvananthapuram
NH 66 Vanchiyoor Thiruvananthapuram Kerala 695001
Thiruvananthapuram
KERALA
695001
India 
Phone  8281120846  
Fax    
Email  darsanaps34@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Indulekha V C 
Designation  Associate Professor 
Affiliation  Government Ayurveda College Thiruvananthapuram 
Address  Department of Dravyaguna Vigyana Government Ayurveda College Thiruvananthapuram
NH 66 Vanchiyoor Thiruvananthapuram Kerala 695001
Thiruvananthapuram
KERALA
695001
India 
Phone  9446553068  
Fax    
Email  drindulekha@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Darsana P S 
Designation  Post Graduate Scholar 
Affiliation  Government Ayurveda College Thiruvananthapuram 
Address  Department of Dravyaguna Vigyana Government Ayurveda College Thiruvananthapuram
NH 66 Vanchiyoor Thiruvananthapuram Kerala 695001
Thiruvananthapuram
KERALA
695001
India 
Phone  8281120846  
Fax    
Email  darsanaps34@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Darsana P S 
Address  Department of Dravyaguna Vigyana Government Ayurveda College Thiruvananthapuram 695001 
Type of Sponsor  Other [Self] 
 
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 Indulekha V C  Government Ayurveda College Thiruvananthapuram  Room no 1, Dravyaguna OP, Department of Dravyaguna vigyana Government Ayurveda College Hospital
Thiruvananthapuram
KERALA 
9446553068

drindulekha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Govt. Ayurveda College Thiruvananthapuram  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: KAMALA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Rohithakadi Yogam, Reference: Tripathi I, Dwivedi R, editors. Chakradatta of Śrī Cakrapāṇidatta: Pliha-Yakrit Cikitsā, sloka 4, p 231, with Vaidyaprabha commentary (Hindi). 3rd ed. Varanasi: Chaukhambha Sanskrit Sansthan; 1997., , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Lukewarm water), Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Diagnosed with cholelithiasis by USG

Gall stone size in between 2mm to 10mm by ultrasonography abdomen  
 
ExclusionCriteria 
Details  Patients with cholelithiasis associated with complications such as Acute obstructive cholecystitis
Pregnancy or lactation  
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
size of gall stone by USG   Assessed on 0th day and 91st day.  
 
Secondary Outcome  
Outcome  TimePoints 
Liver Function Test, lipid
profile, CBC in participants  
Assessed on 0th day and 91st day  
 
Target Sample Size   Total Sample Size="31"
Sample Size from India="31" 
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)   19/02/2026 
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="0"
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  
Cholelithiasis is the medical term for gallstones. Gallstones are crystallized deposits forming 
in the gallbladder or biliary tree primarily composed of cholesterol bilirubin and bile. These 
stones often remain asymptomatic detected incidentally during imaging. However when 
gallstones become larger or when they begin obstructing bile ducts symptoms or attacks
begin to occur such as steady severe pain in the upper abdomen that increases rapidly and may 
last from 30 minutes to several hours radiate between the shoulder blades and right shoulder. 
Gallstone is a common public health problem especially in developed countries. In India 
cholelithiasis affects approximately 4 to 20 percentage of the population with a higher prevalence among 
females and individuals with sedentary lifestyles.  
In Ayurveda cholelithiasis gallstones is understood as a result of dosha imbalance
primarily Pitta and Kapha along with impaired digestion and accumulation of Ama  toxins.
Contributing factors include excessive intake of heavy oily sweet foods guru snigdha 
madhura ahara irregular eating habits and sedentary lifestyle. 
The gallbladder is referred to as Pittashaya in Ayurveda as per WHO International standard 
terminology. Thus some Ayurveda physicians utilize the term Pittashaya ashmari for 
gall bladder stone as the stone which is formed inside pittashaya. Classical texts like Charaka 
Samhita and Ashtanga Hridaya mention a condition called Rudda-patha-Kamala which may 
relate to gallstones obstructing bile flow.
This study aims to evaluate the effect of Rohithakadi Yogam a classical Ayurvedic polyherbal 
formulation in the management of cholelithiasis Participants aged 20 to 60 years irrespective 
of gender and meeting inclusion criteria will be selected from the study setting.  Each 
participant will undergo a detailed clinical evaluation and relevant laboratory investigations. 
Informed consent will be obtained before enrolment.  The intervention group will receive two 
500 mg Rohithakadi Yogam tablets twice daily morning and evening before food for 90 
days. The collected data will be subjected to statistical analysis to assess the safety and efficacy 
of Rohithakadi Yogam in the management of cholelithiasis.
 
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