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CTRI Number  CTRI/2025/11/097960 [Registered on: 24/11/2025] Trial Registered Prospectively
Last Modified On: 21/11/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   How our Food and daily Eating habits lead to Weight Gain 
Scientific Title of Study   A CRITICAL STUDY ON ROLE OF AAHAR DIETARY REGIMEN IN STHAULYA OBESITY WITH SPECIAL REFERENCE TO UPAYOG SAMSTHA 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vikalp Pankajbhai Kubavat 
Designation  PhD Scholar 
Affiliation  Shree Swaminarayan Ayurvedic College 
Address  J-1,Kaivalya Haridwar Bunglows Haridwar Society Joshipura Junagadh
Department of Samhita evum Siddhant Shree Swaminarayan Ayurvedic College Ahmedabad Mehsana Highway Opposite saji GIDC Kalol
Gandhinagar
GUJARAT
362002
India 
Phone  9998258656  
Fax    
Email  vikalp312@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR SUNNY PATIL 
Designation  PROFESSOR and HOD 
Affiliation  Shree Swaminarayan Ayurvedic College 
Address  Department of Samhita evum Siddhant Shree Swaminarayan Ayurvedic College Ahmedabad Mehsana Highway Opposite saji GIDC Kalol
Shree Swaminarayan Ayurvedic College Ahmedabad Mehsana Highway Opposite saji GIDC Kalol
Gandhinagar
GUJARAT
382721
India 
Phone  9664366756  
Fax    
Email  sunnypatil125@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR SUNNY PATIL 
Designation  PROFESSOR and HOD 
Affiliation  Shree Swaminarayan Ayurvedic College 
Address  Department of Samhita evum Siddhant Shree Swaminarayan Ayurvedic College Ahmedabad Mehsana Highway Opposite saji GIDC Kalol
Shree Swaminarayan Ayurvedic College Ahmedabad Mehsana Highway Opposite saji GIDC Kalol
Gandhinagar
GUJARAT
382721
India 
Phone  9664366756  
Fax    
Email  sunnypatil125@gmail.com  
 
Source of Monetary or Material Support  
Shree Swaminarayan Ayurvedic College and Hospital Opposite Saij GIDC Ahmedabad Mehsana Highway At Kalol Dist Gandhinagar Gujarat India PIN 382725 
 
Primary Sponsor  
Name  Shree Swaminarayan Ayurvedic College 
Address  Shree Swaminarayan Ayurvedic College Opposite Saij GIDC Ahmedabad Mehsana Highway At Kalol Dist Gandhinagar Gujarat India PIN 382725 
Type of Sponsor  Other [Private Ayurved Hospital and 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 
Vikalp Kubavat  Shree Swaminarayan Ayurvedic College  Department of Samhita evum Siddhant
Gandhinagar
GUJARAT 		 9998258656

vikalp312@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:E668||Other obesity. Ayurveda Condition: MEDOROGAH, (2) ICD-10 Condition:E663||Overweight. Ayurveda Condition: MEDOROGAH, (3) ICD-10 Condition:E669||Obesity, unspecified. Ayurveda Condition: MEDOROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Presence of Obesity i.e. Weight is more than 20% excess of the desirable weight according to Height sex and age (according to annexed height and body weight table) over age adjusted BMI above 85th percentile (Asian Standard) 
 
ExclusionCriteria 
Details  Obesity secondary to or associated with hyperthyroidism, Hypertention, DM, Hyperlipidemia, Cushings syndrome. Any concomitant serious disorder of the liver Kidneys, Heart, Lungs or other organs. Pregnancy and Lactation. Person undergoing treatment for any other seroious illness  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Aahar has definate role in Sthaulya  20 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Upayog Samstha has more impact on Sthaulya  20 Weeks 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
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   N/A 
Date of First Enrollment (India)   06/12/2025 
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="2"
Months="6"
Days="15" 
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  

This study addresses a crucial research gap by empirically validating Ayurvedic dietetics in the context of obesity management.

This research aims to critically evaluate the influence of Aahar and Upayog Samstha in Sthaulya, contributing novel insights from an Ayurvedic framework and employs a robust observational and survey based design.

500 sample size ensures statistical power amd generalizability of findings which enhance the validation of the study.

The research follows a systematic workflow, ensuring comprehensive data collection, rigorous analysis and actionable insights.

Aim of the study is to observe the role of Aahar (Diet) with special reference to Upayog Samstha in Sthaulya.

 
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