| CTRI Number |
CTRI/2026/04/109000 [Registered on: 21/04/2026] 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 an Integrated Care Model Incorportaing Meditation in the Management of Stage I Hypertension |
|
Scientific Title of Study
|
EVALUATION OF THE THERAPEUTIC EFFECTIVENESS OF AN INTEGRATED CARE MODEL INCORPORATING MEDITATION IN THE MANAGEMENT OF STAGE I HYPERTENSION. 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 |
Resident Medical Officer |
| Affiliation |
Patanjali Wellness |
| Address |
OPD No 17
Department of Panchkarma
Patanjali Wellness
Delhi Haridwar National Highway Near Bahadrabad Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9039402300 |
| Fax |
|
| Email |
drajaysingh82@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay Singh |
| Designation |
Resident Medical Officer |
| Affiliation |
Patanjali Wellness |
| Address |
OPD No 17
Department of Panchkarma
Patanjali Wellness
Delhi Haridwar National Highway Near Bahadrabad Haridwar
UTTARANCHAL
249405
India |
| Phone |
9039402300 |
| Fax |
|
| Email |
drajaysingh82@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajay Singh |
| Designation |
Resident Medical Officer |
| Affiliation |
Patanjali Wellness |
| Address |
OPD No 17
Department of Panchkarma
Patanjali Wellness
Delhi Haridwar National Highway Near Bahadrabad Haridwar
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:I10||Essential (primary) hypertension. Ayurveda Condition: RAKTAVRUTAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Stage 1 Hypertension. (SBP 140-145 mm Hg, DBP 90-95 mm Hg)
The subject is able and willing to provide consent
|
|
| ExclusionCriteria |
| Details |
Pregnant or lactating women, plaaning for pregnancy
Uncontrolled HTN, Stage 2 HTN
Any condition that investigator identifies can confound the participant ability to participate in the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in SBP/DBP |
Baseline (Day 1) to Day 15 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • Changes in World Health Organization Quality of Life assessment instrument (WHOQOL-BREF) |
Baseline (Day 1) to 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 aims to investigate and interpretation of the effectiveness assessment of an Integrative Care Model Incorporating Meditation in the Management of Elevated and Stage 1 Hypertension. By assessing the effectiveness of this integrated approach, we seek to contribute to the growing body of evidence on complementary and alternative approaches to blood pressure management, ultimately improving outcomes and quality of life for individuals living with Elevated and Stage 1 Hypertension. |