| CTRI Number |
CTRI/2023/10/058423 [Registered on: 06/10/2023] Trial Registered Prospectively |
| Last Modified On: |
15/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Yoga & Naturopathy
Other (Specify) [Heartfulness Meditation ] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Impact of Heartfulness Meditation on T Cell
Immune Response and Stress |
|
Scientific Title of Study
|
Study of T Cell Immunomodulation and Stress Biomarkers in Subjects
Enrolled for Heartfulness Meditation Program |
| 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 Mansee Thakur |
| Designation |
Professor and Head |
| Affiliation |
MGM School of Biomedical Sciences, MGMIHS |
| Address |
Department of Medical Biotechnology, MGM School of Biomedical Sciences, MGMIHS Sector-1 Kamothe Navi Mumbai
Raigarh
MAHARASHTRA
410209
India |
| Phone |
09769909212 |
| Fax |
|
| Email |
mansibiotech79@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mansee Thakur |
| Designation |
Professor and Head |
| Affiliation |
MGMSBS, MGMIHS |
| Address |
Department of Medical Biotechnology, MGM School of Biomedical Sciences, MGMIHS Sector-1 Kamothe Navi Mumbai
Raigarh
MAHARASHTRA
410209
India |
| Phone |
09769909212 |
| Fax |
|
| Email |
mansibiotech79@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms. Sanjana T. Philip |
| Designation |
Ph.D. Scholar |
| Affiliation |
Department of Medical Biotechnology |
| Address |
Department of Medical Biotechnology, MGM School of Biomedical Sciences, MGM Institute of Health Sciences, Sector-1 Kamothe Navi Mumbai
MGM School of Biomedical Sciences, MGM Institute of Health Sciences
Raigarh
MAHARASHTRA
410209
India |
| Phone |
8850431229 |
| Fax |
|
| Email |
tsanjanaphilip8@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM School of Biomedical Sciences, MGMIHS, Kamothe, Navi Mumbai |
|
|
Primary Sponsor
|
| Name |
Dr Mansee Thakur |
| Address |
MGM School of Biomedical Sciences, MGMIHS, Kamothe, Navi Mumbai |
| Type of Sponsor |
Other [self] |
|
|
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 Mansee Thakur |
MGM Central Research Laboratory, Department of Medical Biotechnology, MGMSBS |
Room No 1, IInd floor, MGM School of Biomedical Sciences MGMIHS Sector-1 Kamothe Navi Mumbai
Raigarh
MAHARASHTRA |
09769909212
mansibiotech79@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of Research on Human Subjects of MGM Institute of Health Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers with Stress as assessed by Perceived Stress Scale |
| Patients |
(1) ICD-10 Condition: Z733||Stress, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group (No Heartfulness Meditation) |
Heartfulness meditation will be not be carried out in the control group. They will serve as placebo-controlled group for 12 weeks. |
| Intervention |
Heartfulness Meditation |
Heartfulness meditation will be carried out in the experimental group for 12 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
24.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy volunteers with no history of bacterial/viral/fungal infections from the past two months.
2. None of the participants should have any prior experience of practice in any meditation technique. |
|
| ExclusionCriteria |
| Details |
1. The volunteers with a lifetime history of psychosis, bipolar disorder, major
depressive disorder, substance abuse or dependence, a significant head injury, a
seizure disorder, mental retardation, autoimmune disorders, immunodeficiency disorders and neurological disorders.
2. Pregnant women. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Mean Perceived Stress Score
2. Mean Maslach Burnout Inventory (MBI) Score
3. Mean World Health Organization- Well-being Index (WHO-WBI) Score
4. Serum Cortisol/MDA/Nitrate levels
5. T cell immune response and cytokine secretion profile |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To understand the immunomodulatory function of Heartfulness meditation via the activation of
CD3/28 pathways and the cytokine secretion levels after meditation.
2. Development of Process and Protocols for Reliable Measurements of immunomodulation of T Helper cell Using Flow Cytometry.
3. To provide scientific data to demonstrate that the immune system can be voluntarily
influenced by non-pharmaceutical interventions like Heartfulness Meditation.
4. It will also aid in achieving the main vision of “WHO Special Initiative for Mental Health 2019-2023†ie. to provide highest standard of mental health and well-being.
5. Meditation as a behavioral intervention will be used as a preventive measure to improve mental health and well-being.
|
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/10/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
1. Effect of Heartfulness Meditation on Stress Biomarkers, Burnout and Well-Being:A Randomized Controlled Study |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This
study is a randomized, participant blinded, parallel group, placebo-controlled trial,
comparing the mean scores of Perceived Stress Score (PSS), Maslach Burnout
Inventory (MBI), World Health Organization- Well-being Index (WHO-WBI), Serum
Cortisol/MDA/Nitrate levels, T cell immune response and cytokine secretion
profile, pre and post intervention of 12 weeks. This will help us to understand
the immunomodulatory function of Heartfulness meditation via
the activation of CD3/28 pathways and the cytokine secretion levels
after meditation. This will provide scientific data to demonstrate that
the immune system can be voluntarily influenced by non-pharmaceutical interventions
like Heartfulness Meditation. It will also aid in achieving the main
vision of “WHO Special Initiative for Mental Health 2019-2023†ie. to provide
highest standard of mental health and well-being. The
hypothesis of this study is that as T cells are an essential arm of
cell-mediated immunity that mount anti-pathogenic and anti-cancer immune
responses. Analyzing these cells gives a deeper insight into the immune profile
of an individual. The cytokine secretion
profile will also be analysed. This will provide us with vital information on
inflammatory responses. This research intends to present a comparative picture
between the meditator and non-meditator participants and attempts to uncover
new paths to enhancing lifestyle performance using heartfulness meditation as
an intervention and thereby identifying an approach to contribute towards
improving overall health and wellbeing. |