| CTRI Number |
CTRI/2026/04/108691 [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 |
Other |
|
Public Title of Study
|
Effect of Quality of Life in Type 2 Diabetes Mellitus |
|
Scientific Title of Study
|
Evaluation of the Quality of Life in the Management of Type 2 Diabetes Mellitus with Integrated Care Model Incorporating Meditation 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 Anurag Sharma |
| Designation |
Resident Medical Officer |
| Affiliation |
Yog Naturopathy Panchkarma Treatment and Research Centre |
| Address |
OPD No 13
Panchkarma Department Patanjali Yoggram
Yog Naturopathy Panchkarma Treatment and Research Centre Yoggram Village Aurangabad Near SIDCUL Roshnabad
Hardwar
UTTARANCHAL
249402
India |
| Phone |
8171510464 |
| Fax |
|
| Email |
dr.anuragsharma1987@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anurag Sharma |
| Designation |
Resident Medical Officer |
| Affiliation |
Yog Naturopathy Panchkarma Treatment and Research Centre |
| Address |
OPD No 13
Panchkarma Department Patanjali Yoggram
Yog Naturopathy Panchkarma Treatment and Research Centre Yoggram Village Aurangabad Near SIDCUL Roshnabad
Hardwar
UTTARANCHAL
249402
India |
| Phone |
8171510464 |
| Fax |
|
| Email |
dr.anuragsharma1987@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anurag Sharma |
| Designation |
Resident Medical Officer |
| Affiliation |
Yog Naturopathy Panchkarma Treatment and Research Centre |
| Address |
OPD No 13
Panchkarma Department Patanjali Yoggram
Yog Naturopathy Panchkarma Treatment and Research Centre Yoggram Village Aurangabad Near SIDCUL Roshnabad
Hardwar
UTTARANCHAL
249402
India |
| Phone |
8171510464 |
| Fax |
|
| Email |
dr.anuragsharma1987@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Research Foundation governed by Patanjali Research Foundation Trust NH 58 Near Bahadrabad Haridwar 249405 Uttarakhand India |
|
|
Primary Sponsor
|
| Name |
Patanjali Research Foundation |
| Address |
NH 58 Near Bahadrabad Haridwar 249405 Uttarakhand 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 17 Department of Panchkarma Patanjali Wellness Delhi Haridwar National Highway Near Bahadrabad Haridwar 249405 Uttarakhand India
Hardwar
Hardwar
UTTARANCHAL |
9039402300
drajaysingh82@gmail.com |
| Dr Anurag Sharma |
Patanjali Yoggram |
OPD 13
Department of Panchkarma
Yog Naturopathy Panchkarma Treatment and Research Centre Yoggram Village Aurangabad Near SIDCUL Roshnabad Haridwar 249402
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:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with T2DM having HbA1C range from 5.7% to 10% and FBS below 180 mg/dl. |
|
| ExclusionCriteria |
| Details |
Patients with Type-1 DM or on insulin
Having gestational diabetes, uncontrolled HTN
Planning for pregnancy or lactating and pregnant women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • Changes in World Health Organization Quality of Life assessment instrument (WHOQOL-BREF) |
Baseline (Day 1), Day 07 and Day 15 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in HbA1C |
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)
|
18/05/2026 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Other (Terminated) |
| 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 aims to investigate and
interpretation of the effectiveness assessment of an Integrative Care Model
Incorporating Meditation in the Management of Type 2 Diabetes Mellitus. By
assessing the effectiveness of this integrated approach, we seek to contribute
to the growing body of evidence on complementary and alternative approaches to
diabetes management, ultimately improving outcomes and quality of life for
individuals living with T2DM |