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CTRI Number  CTRI/2026/04/108000 [Registered on: 09/04/2026] Trial Registered Prospectively
Last Modified On: 16/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare the effect of Vidangadi Churna and Lekhaneeya Mahakashaya Churna in the management of Obesity 
Scientific Title of Study   RANDOMISED COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF VIDANGADI CHURNA AND LEKHANEEYA MAHAKASHAYA CHURNA IN THE MANAGEMENT OF STHAULYA W.S.R.TO OBESITY 
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 Pratibha Jethwa 
Designation  PG SCHOLAR 
Affiliation  Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan 313001 
Address  PG Department Of Kayachikitsa Madan Mohan Malviya Government Ayurved College Udaipur Near Radaji Circle

Udaipur
RAJASTHAN
313001
India 
Phone  9413188877  
Fax    
Email  pjethwa07@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ravi Sharma 
Designation  Professor and HOD 
Affiliation  Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan 313001 
Address  PG Department Of Kayachikitsa Madan Mohan Malviya Government Ayurved College Udaipur Near Radaji Circle

Udaipur
RAJASTHAN
313001
India 
Phone  9001669259  
Fax    
Email  face.udr@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pratibha Jethwa 
Designation  PG SCHOLAR 
Affiliation  Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan 313001 
Address  PG Department Of Kayachikitsa Madan Mohan Malviya Government Ayurved College Udaipur Near Radaji Circle

Udaipur
RAJASTHAN
313001
India 
Phone  9413188877  
Fax    
Email  pjethwa07@gmail.com  
 
Source of Monetary or Material Support  
Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan 313001 
 
Primary Sponsor  
Name  Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan 313001 
Address  Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan 313001 
Type of Sponsor  Government medical college 
 
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 Pratibha Jethwa  Madan Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan  OPD NO 1 PG Department Of Kayachikitsa Madan Mohan Malviya Government Ayurved College Udaipur Near Radaji Circle 313001
Udaipur
RAJASTHAN 		 9413188877

pjethwa07@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E660||Obesity due to excess calories. Ayurveda Condition: ATISTHAULYAM (KEVALA-KAPHA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Lekhaneeya Mahakashaya Churna, Reference: Charak Samhita Sutra Sthan 4/8, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: NA
2Intervention ArmDrugClassical(1) Medicine Name: Vidangadi Churna , Reference: Bhaisajya Ratnawali, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: NA
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Patients with age group 18 to 60 years.
2 BMI Between 25 to 39.9
3 Patients with symptoms of sthaulya mentioned in Ayurveda text.
 
 
ExclusionCriteria 
Details  1 BMI less than 25 and equal or more than 40
2 Patients below the age of 18 years and above 60 years.
3 Patients having cardiovascular complications.
4 Pregnant & lactating women.
5 Patients with uncontrolled Diabetes Mellitus, Hypertension, Hypothyroidism and Drug induced obesity.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Relief in sign and symptoms  60 days 
 
Secondary Outcome  
Outcome  TimePoints 
Find changes in BMI
Find changes in Waist Hip Ratio
Find changes in Random Blood Sugar
Find changes in Lipid Profile 		 60 days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 
Date of First Enrollment (India)   01/07/2026 
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="0"
Months="11"
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  

RANDOMISED COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF VIDANGADI CHURNA AND LEKHANEEYA MAHAKASHAYA CHURNA IN THE MANAGEMENT OF STHAULYA W.S.R. TO OBESITY


There will be two group in the study, in Group A randomly selected and clinically diagnosed 30 patients of Sthaulya will be given Vidangadi Churna after meal twice a day, Group B 30 patients of Sthaulya will be given Lekhaneeya Mahakashaya Churna after meal  twice a day. Both trial will be conducted for a period of 2 months. Follow up of the case will be after 15 days which will be four times  during trial period. Final assessment will be done after completion of two month course on the of subjective, objective paramerters and laborateral assessment.

 
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