| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E663||Overweight. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | placebo | | | 2 | Intervention Arm | Lifestyle | - | - | 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. |