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CTRI Number  CTRI/2025/11/096960 [Registered on: 06/11/2025] Trial Registered Prospectively
Last Modified On: 05/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study comparing Trivutta Avaleha and Vidangatanduladi Yoga in Obesity. 
Scientific Title of Study   Comparative clinical evaluation of Virechna by Trivutta Avaleha and Vidangatanduladi Yoga in the management of Sthoulya (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  DrDiksha Kharat  
Designation  Ph.D Scholar  
Affiliation  Bharati Vidyapeeth ( Deemed to be University)College of Ayurved ,Dhankawadi Pune  
Address  Bharati Vidyapeeth ( Deemed to be University) College of Ayurved, Dhankawadi-Pune Maharashtra.

Pune
MAHARASHTRA
411043
India 
Phone  8956546908  
Fax    
Email  kharatdiksha18@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrManjula Matekar  
Designation  Associate Professor (Department of Panchakarma) 
Affiliation  Bharati Vidyapeeth ( Deemed to be University)College of Ayurved ,Dhankawadi Pune  
Address  Bharati Vidyapeeth ( Deemed to be University) College of Ayurved, Dhankawadi-Pune Maharashtra.

Pune
MAHARASHTRA
411043
India 
Phone  9890254424  
Fax    
Email  manju.matekar@bharatividyapeeth.edu  
 
Details of Contact Person
Public Query  
Name  DrManjula Matekar  
Designation  Associate Professor (Department of Panchakarma) 
Affiliation  Bharati Vidyapeeth ( Deemed to be University)College of Ayurved ,Dhankawadi Pune  
Address  Bharati Vidyapeeth ( Deemed to be University) College of Ayurved, Dhankawadi-Pune Maharashtra.

Pune
MAHARASHTRA
411043
India 
Phone  9890254424  
Fax    
Email  manju.matekar@bharatividyapeeth.edu  
 
Source of Monetary or Material Support  
Bharati Vidyapeeth (Deemed to be University) College of Ayurved and Hospital Dhankawadi-Pune 411043 Maharashtra,India  
 
Primary Sponsor  
Name  DrDiksha Kharat  
Address  Bharati Vidyapeeth (Deemed to be University) College of Ayurved and Hospital Department of Panchakarma, Dhankawadi-Pune 411043 Maharashtra, India  
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 
DrDiksha Kharat   Bharati Vidyapeeth ( Deemed to be University) College of Ayurved and Hospital   Bharati Vidyapeeth (Deemed to be University) College of Ayurved and Hospital, Department of Panchakarma OPD No.21 Dhankawadi-Katraj, Pune 411043
Pune
MAHARASHTRA 		 8956546908

kharatdiksha18@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICS COMMITTEE [BV(DU)COA-EC]  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E669||Obesity, unspecified. Ayurveda Condition: MEDOROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-Deepan-Pachan, Abhyankar snehapan, Snehan -Swedan, Virechna, Sansarjan kram (Procedure Reference: अ.हृ.क.2/15-16, Procedure details: Dipan Pachan 3-5 days (with Hingavashtak Churna) Abhyantar Snehapana according to Koshtha (Murchit Go-Ghrit ) 3-5-7 Days Snehan-Swedan (Vishram din) – 3 days Next day Snehan-Swedan purvak Virechan Karma)
(1) Medicine Name: Vidangatanduladi Yoga , Reference: अ.हृ.क.2/15-16, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 60(g), Frequency: od, Duration: 1 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1)Patients between age group of 18 to 50 years will be included.
2)Individuals having clinical signs and symptoms of Sthoulya.(Anga Gaura ,Utsah Hani
Swedadhikya ,Anga Daurgandya.)
3)Individuals having BMI Above 27 kg/m² to 30 kg/m2
4)Those who will fit for Virechan Karma. 
 
ExclusionCriteria 
Details  1)Patients contraindicated for Virechan Karma, Pregnant women and lactating women.
2)Patients of known hypothyroidism or any hormonal imbalance disorder, psychological
disorder, use of long-term steroid therapy or any weight loss medication. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Percent change in bodyweight individually(5%).   At baseline (before treatment), after completion of Virechana, and during follow-up on 30th day and 45th day from Abhyantara Snehapana. 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in: 1)
Anthropometric and body compositional parameters. 2)Biochemical parameters (High densitylipoprotein,Triglycerides)
3)Subjective criteria parameters. 		 30th & 45th day of Abhyantar Snehapana. 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   10/12/2025 
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="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   In global problem, Obesity in Ayurveda has been described as Sthoulya or Medoroga.Sthoulya is one among the prevalent disease now a days due to change in lifestyle, Fast food, Over eating, Sedentary lifestyle, lack of exercises. Sthoulya if left untreated which provides the platform for so many other diseases like – Hypertension, Diabetes Mellitus, Coronary Heart Disease, Osteoarthritis, Infertility ,Impotency etc. and it can be life threatening. Hence it’s management in early stage is necessary to avoid further complications. Sthoulya is a disease resulting due to excessive incorporation of Kapha Vardhak and Medovardhak Aahar Vihara by a person. In Ayurveda, Sthoulya is described under names of SantarpanajanyaVikara, Ashtaunindita Purush, Shushma Nanatmaja Vyadhi and Medo Dhatupradoshaja Vikara.Virechan is one of the Pradhan Shodhan Karma to eliminate Tridosha and establish normal conditions (Dosha, Dhatu, Mala, Satmya Avastha ) in body.Trivrutta Avaleha is an Ayurvedic medicine having purgative properties. Trivrutta is regarded as the most effective drug for Sukhavirechana and Bhedan. It is a highly recommended drug that has proven to be a milestone in the commencement of Virechan Karma.In this study, Trivritta Avaleha will be used for Virechana Karma as a control group.Vidangatanduladi Yoga is having purgative properties. Vidangatanduladi Churna is palatable as it should be consumed with Madhu. As it is indicated to use in Kaphaj ,Vataj Vikar it can be used in Sthoulya. In the efficacy of drug it’s stated that both medicines are potent in managing disease of Sthoulya. In the particular study under standard measures we are going to compare the efficacy of both these drugs through Virechan in the disease of Sthoulya.Till now no comparative studies were performed on Virechan by Trivrutta Avaleha and Vidangatanduladi Yoga in Sthoulya. Here we are comparing efficacy of Trivrutta Avaleha and Vidangatanduladi Yoga as Virechana in Sthoulya.So to check its potency and efficacy as a Virechana drug in Sthoulya this study has been choosen. 
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