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CTRI Number  CTRI/2025/03/081636 [Registered on: 04/03/2025] Trial Registered Prospectively
Last Modified On: 28/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Study on the impact of lifestyle changes in obese patients 
Scientific Title of Study   Evaluation of the effect of lifestyle modification in obese patients a single arm study 
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 Aakanksha  
Designation  PG SCHOLAR 
Affiliation  DELHI UNIVERSITY 
Address  Room number 622 seminar hall department of swasthavritta ALL INDIA INSTITUTE OF AYURVEDA MATHURA ROAD GAUTAM PURI SARITA VIHAR DELHI

South
DELHI
110076
India 
Phone  9560413368  
Fax    
Email  varun7226@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Aakanksha  
Designation  PG SCHOLAR 
Affiliation  DELHI UNIVERSITY 
Address  ROOM NUMBER 622 SEMINAR HALL DEPARTMENT OF SWATHAVRITTA ALL INDIA INSTITUTE OF AYURVEDA MATHURA ROAD GAUTAM PURI SARITA VIHAR DELHI

South
DELHI
110076
India 
Phone  9560413368  
Fax    
Email  varun7226@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Aakanksha  
Designation  PG SCHOLAR 
Affiliation  DELHI UNIVERSITY 
Address  ROOM NUMBER 622 SEMINAR HALL DEPARTMENT OF SWATHVRITTA ALL INDIA INSTITUTE OF AYURVEDA MATHURA ROAD GAUTAM PURI SARITA VIHAR DELHI

South
DELHI
110076
India 
Phone  9560413368  
Fax    
Email  varun7226@gmail.com  
 
Source of Monetary or Material Support  
ALL INDIA INSTITUTE OF AYUVEDA (AIIA) MATHURA ROAD , NH-19,GAUTAM PURI SARITA VIHAR, DELHI - 110076 
 
Primary Sponsor  
Name  ALL INDIA INSTITUTE OF AYUVEDA 
Address  MATHURA ROAD GAUTAM PURI SARITA VIHAR DELHI 110076 
Type of Sponsor  Other [] 
 
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 Garima Srivastava  All India Institute of Ayurveda  OPD No. 8b, 109c, screening OPD and Hospital block, Gautampuri, Delhi
South
DELHI 
7017310982

Drgarima04@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:E663||Overweight. Ayurveda Condition: MEDOROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-placebo
2Intervention ArmLifestyle--Dinacarya: dincharya, Ritucarya: ritucharya, Acara Rasayana:acara rasayan, Other:pathya/apthya, Pathya/Apathya:no, Pathya:, Apathya:
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  obese patient of all gender with bmi 30-40. patients presenting with classical symptoms of sthaulya. 
 
ExclusionCriteria 
Details  patients having diagnosed hypertension,thyrotoxicosis,diabetes mellitus, hyperparathyroidism, chronic renal diseases,hyperthyroidism, hypothyroidism.
obese patients with severe complication.
pregnant and lacatating women.
patients who have refused to give written informed consent . 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
- Changes in symptoms of medoroga.
- Changes in symptoms of fatigue.
- Overall improvement in quality of life.
- Changes in WEIGHT
- BMI
- WAIST TO HIP RATIO
- WAIST CIRCUMFERENCE
- CBC
- TRYGLYCERIDES
- CHOLESTEROL
- LFT
- VITAMIN B-12
- VITAMIN D

 
90 days

 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in symptoms of medoroga.
- Changes in symptoms of fatigue.
- Overall improvement in quality of life.
- Changes in WEIGHT
- BMI
- WAIST TO HIP RATIO
- WAIST CIRCUMFERENCE
- CBC
- TRYGLYCERIDES
- CHOLESTEROL
- LFT
- VITAMIN B-12
- VITAMIN D

 
3 month 
 
Target Sample Size   Total Sample Size="178"
Sample Size from India="178" 
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)   25/03/2025 
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="0"
Months="3"
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  

Obesity is becoming an increasingly prevalent global health issue, contributing to various chronic conditions like heart disease, diabetes, musculoskeletal problems, and certain types of cancer. The prevalence of obesity is rising in countries like India, with notable increases in both adult and childhood obesity rates. This surge is driven by an imbalance between the number of calories consumed and the number of calories burned, largely influenced by modern lifestyles that promote unhealthy eating habits and sedentary behavior. The growing problem of obesity poses not only physical health risks but also significant psychological impacts, including low self-esteem, depression, and social stigma. These psychological effects, combined with the physical consequences, lead to higher healthcare costs, lost productivity, and increased premature death rates.The research project aims to investigate the role of lifestyle modifications, including dietary changes, physical activity, and yoga therapy, in managing obesity. It seeks to explore whether these lifestyle changes can lead to significant weight loss and improvement in overall health. Specifically, the study will examine the primary impact of these modifications on weight management, as well as secondary benefits such as improvements in quality of life and reductions in symptoms related to obesity-associated diseases, particularly those described in Ayurvedic medicine, like Medoroga.

Lifestyle modifications, such as healthy eating habits, regular exercise, stress management, and sufficient sleep, are recognized as essential strategies for weight management. These practices not only help individuals lose weight but also contribute to long-term health maintenance. The Ayurvedic approach to obesity views it as an imbalance in the body’s fat tissues, often caused by poor dietary choices, lack of exercise, and inadequate sleep. Ayurveda offers a holistic approach to weight management, focusing on correcting these lifestyle factors, which it refers to as Nidanas, the root causes of obesity. Ayurveda also emphasizes the importance of a balanced diet, regular physical activity, and daily routines for overall health and well-being.Despite the growing recognition of lifestyle modification as a key factor in weight management, research on the effectiveness of Ayurvedic practices in managing obesity is limited. This study seeks to fill that gap by combining Ayurvedic principles with modern techniques like yoga and lifestyle changes. By doing so, it hopes to provide a more comprehensive, sustainable, and patient-centered solution to managing obesity, offering insights that could benefit individuals, healthcare providers, and public health policies.

In summary, the research aims to evaluate the impact of lifestyle modifications in managing obesity, focusing on weight loss and improved quality of life, while integrating Ayurvedic concepts with modern health practices. The results could offer a holistic approach to obesity management, with long-term benefits for both physical health and emotional well-being.

 
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