FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/07/055596 [Registered on: 24/07/2023] Trial Registered Prospectively
Last Modified On: 27/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   CHECK OUT THE EFFECTIVENESS OF TRIPHALADI TAILA AND SAINDHAVA YUKTA SARSHAPA TAILA IN THE MANAGEMENT OF OBESITY  
Scientific Title of Study   EFFICACY OF TRIPHALADI TAILA MATRA BASTI AND SAINDHAVA YUKTA SARSHAPA TAILA MATRA BASTI IN THE MANAGEMENT OF STHAULYA ( OBESITY ): AN OPEN LABELLED RANDOMIZED COMPARATIVE CLINICAL TRIAL 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DHRUVKUMAR JANI 
Designation  PG SCHOLAR  
Affiliation  Government Akhandanand Ayurveda College and Hospital, Bhadra , Ahmedabad 
Address  OPD NO.5 Department of Panchakarma, Government Akhandanand Ayurveda College and Hospital, Bhadra , Ahmedabad

Ahmadabad
GUJARAT
380001
India 
Phone  9726894706  
Fax    
Email  janidhruv104@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Vd Falgun Patel 
Designation  Reader , Government Akhandanand Ayurveda Colloge , Bhadra , Ahmedabad 
Affiliation  Government Akhandanand Ayurveda College and Hospital, Bhadra , Ahmedabad 
Address  OPD NO.5 Department of Panchakarma, Government Akhandanand Ayurveda College and Hospital, Bhadra , Ahmedabad

Ahmadabad
GUJARAT
380001
India 
Phone  9426404004  
Fax    
Email  vd.falgun@gmail.com  
 
Details of Contact Person
Public Query  
Name  Vd Falgun Patel 
Designation  Reader , Government Akhandanand Ayurveda Colloge , Bhadra , Ahmedabad 
Affiliation  Government Akhandanand Ayurveda College and Hospital, Bhadra , Ahmedabad 
Address  OPD NO.5 Department of Panchakarma, Government Akhandanand Ayurveda College and Hospital, Bhadra , Ahmedabad

Ahmadabad
GUJARAT
380001
India 
Phone  9426404004  
Fax    
Email  vd.falgun@gmail.com  
 
Source of Monetary or Material Support  
Government Akhandanand Ayurveda College and Hospital  
 
Primary Sponsor  
Name  Government Akhandanand Ayurveda College  
Address  Government Akhandanand Ayurveda College and Hospital, Bhadra , Ahmedabad 
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 DHRUVKUMAR JANI  Government Akhandanand Ayurveda College and Hospital, Bhadra , Ahmedabad  OPD NO.5 Department of Panchakarma, Government Akhandanand Ayurveda College and Hospital, Bhadra , Ahmedabad
Ahmadabad
GUJARAT 		 9726894706

janidhruv104@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E663||Overweight. Ayurveda Condition: ATISTHAULYAM (KEVALA-KAPHA), (2) ICD-10 Condition:E663||Overweight. Ayurveda Condition: ATISTHAULYAM (KEVALA-KAPHA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-mAtrAbastiH, मात्राबस्तिः (Procedure Reference: Bhavaprakasha samhita Madhyam khanda 39/ 16 , Procedure details: Purva karma - sthanik abhyanga with triphaladi taila 50 ml and swedana (Nadi swedana) Pradhana karma - Matra basti with triphaladi taila - 40 ml Paschata karma - tapping at thigh and buttocks region )
2Comparator ArmProcedure-mAtrAbastiH, मात्राबस्तिः (Procedure Reference: Sushruta samhita Sutra sthana 45/17, Procedure details: Purva karma - sthanik abhyanga with Saindhava yukta Sarshapa taila (50 ml) and swedana ( Nadi swedana) Pradhana karma - Matra basti with Saindhava yukta Sarshapa taila - 40 ml Paschata karma - tapping at thigh and buttocks region )
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients presenting with the classical signs and symptoms of STHAULYA (OBESITY) will be taken into consideration like ,
(1) BHAR VRIDDHI(weight gain)
(2) GATRA-GAURAVATA(heaviness in body),
(3) SWEDADHIKYA(excessive sweating),
(4) ATI-NIDRA(excessive sleep),
(5) ATI-KSHUDHA(excessive hunger),
(6) ATI-PIPASA( excessive thirst).
(7) Patients with BMI between 25 to 35
will be taken 
 
ExclusionCriteria 
Details  Patients having
(1)Cardiac,
(2)Renal ,
(3) Hepatic disease,
(4) Pregnant and lactating women,
(5) Persons having Pittaja Prakriti,
(6) Pittaja Vikara ,
(7) Gudadaha ,
(8) Parikartika will be excluded.
(9) Patients with BMI less than 25 and greater than 35 will be excluded. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
(1)Weight lose
(2)Lightness in body
(3)Suppression of excessive hunger
(4)Suppression of excessive thirst
(5) Adequate sleep  		 21 days 
 
Secondary Outcome  
Outcome  TimePoints 
Find improvement in signs & symptoms of Sthaulya with the help of scoring pattern , Body weight- Body circumeferences-Skin fold thickness  21 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   01/08/2023 
Date of Study Completion (India) 30/05/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  		 Sthaulya(Obesity) is considered as a life-style disorder.In present era from child to old age person everyone suffers from Obesity because of bad food habit as well as change in living style. It is one of the most serious health problems of 21st century. Ayurveda has a great approach to obesity in the manner of not just to reduce the weight but also to improve the quality of life. 
In Bhavprakash Samhita Acharya mentioned use of Triphaladi Taila in various manners as Consumption, Massaging, Enema. Here Enema is selected because the study of other method is either done or under going. Sarshapa taila is considered as Medogna( Scrapping) in Sushruta Samhita. So it is also given through enema. So both this drugs are selected in the management of Sthaulya ( obesity )
 
Close