| CTRI Number |
CTRI/2026/04/108635 [Registered on: 20/04/2026] Trial Registered Prospectively |
| Last Modified On: |
10/06/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of the Integrated Care Model Incorporating Meditation in the Management of Obesity |
|
Scientific Title of Study
|
Evaluation of the Therapeutic Effectiveness of an Integrated Care Model Incorporating Meditation in the Management of Obesity An Observational Clinical 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 Ajay Singh |
| Designation |
Associate Professor |
| Affiliation |
Patanjali Wellness |
| Address |
OPD No 17
Department of Panchkarma Patanjali Wellness
Delhi Haridwar National Highway Near Bahadrabad Haridwar 249405 Uttarakhand India
Hardwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9039402300 |
| Fax |
|
| Email |
drajaysingh82@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay Singh |
| Designation |
Associate Professor |
| Affiliation |
Patanjali Wellness |
| Address |
OPD No 17
Department of Panchkarma Patanjali Wellness
Delhi Haridwar National Highway Near Bahadrabad Haridwar 249405 Uttarakhand India
Hardwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9039402300 |
| Fax |
|
| Email |
drajaysingh82@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajay Singh |
| Designation |
Associate Professor |
| Affiliation |
Patanjali Wellness |
| Address |
OPD No 17
Department of Panchkarma Patanjali Wellness
Delhi Haridwar National Highway Near Bahadrabad Haridwar 249405 Uttarakhand India
Hardwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9039402300 |
| Fax |
|
| Email |
drajaysingh82@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Research Foundation Governed by Patanjali Research Foundation Trust NH 58 Near Bahadrabad Haridwar Uttarakhand 249405 India |
|
|
Primary Sponsor
|
| Name |
Patanjali Research Foundation |
| Address |
NH 58 Near Bahadrabad Haridwar Uttarakhand 249405 India |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ajay Singh |
Patanjali Wellness |
OPD No 17 Department of Panchkarma Patanjali Wellness Delhi Haridwar National Highway Near Bahadrabad Haridwar
Hardwar
UTTARANCHAL |
9039402300
drajaysingh82@gmail.com |
| Dr Anurag Sharma |
Patanjali Yoggram |
OPD No 13 Department of Panchkarma Patanjali Yoggram Yog Naturopathy Panchkarma Treatment and Research Centre Yoggram Village Aurangabad Near SIDCUL Roshnabad Haridwar
Hardwar
UTTARANCHAL |
8171510464
dr.anuragsharma1987@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| PATANJALI AYURVED COLLEGE ETHICS COMMITTEE |
Approved |
| PATANJALI AYURVED COLLEGE ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E669||Obesity, unspecified. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed based on BMI from 25- 30 Kg/m2.
The subject is able and willing to provide consent. |
|
| ExclusionCriteria |
| Details |
Uncontrolled HTN
Uncontrolled DM, Grade 4 Obesity, Hyperthroidism/Hypothyroidism
Chronic liver failure, Chronic kidney disease, severe coronary disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Body Weight(kg) |
Baseline (Day 1), Day 07 and Day 15. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in Body Mass Index (BMI, kg/m²) |
Baseline (Day 1), Day 07 and Day 15. |
| Change in Body Weight(kg) |
Baseline (Day 1), Day 07 and Day 15. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
11/05/2026 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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 will assess the effectiveness of Integrative Care Model Incorporating
Meditation in patients with Obesity.
Patients will be
screened on the basis of Inclusion/Exclusion criteria and enrolled after obtaining
written Informed consent. The Patients will be followed-up for the next 15 days
from the day of enrolment and all the data will be collected from the patients
in a structured case report form. |