| CTRI Number |
CTRI/2025/05/087930 [Registered on: 30/05/2025] Trial Registered Prospectively |
| Last Modified On: |
28/05/2025 |
| 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
|
Exploring Heartfulness Meditation on Anxiety and Biological Clock |
|
Scientific Title of Study
|
Exploring the Influence of Heartfulness Meditation on Regulation of Gene Expression linked to Anxiety and the Biological Clock
|
| 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, Navi Mumbai |
| Address |
Department of Medical Biotechnology, MGM School of Biomedical Sciences, MGMIHS Sector-1 Kamothe Navi Mumbai
Raigarh
MAHARASHTRA
410209
India
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 |
MGM School of Biomedical Sciences, MGMIHS, Navi Mumbai |
| Address |
Department of Medical Biotechnology, MGM School of Biomedical Sciences, MGMIHS Sector-1 Kamothe Navi Mumbai
Raigarh
MAHARASHTRA
410209
India
Raigarh MAHARASHTRA 410209 India |
| Phone |
09769909212 |
| Fax |
|
| Email |
mansibiotech79@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Ms Suparna Deepak |
| Designation |
Ph.D. Scholar |
| Affiliation |
MGM School of Biomedical Sciences, MGMIHS, Navi Mumbai |
| Address |
Department of Medical Biotechnology, MGM School of Biomedical Sciences, MGMIHS Sector-1 Kamothe Navi Mumbai
Raigarh
MAHARASHTRA
410209
India
Raigarh MAHARASHTRA 410209 India |
| Phone |
09870749570 |
| Fax |
|
| Email |
suparna_knr@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| MGM School of Biomedical Sciences, MGMIHS, Kamothe, Navi Mumbai, Raigad, Maharashtra, INDIA-410209 |
|
|
Primary Sponsor
|
| Name |
Dr Mansee Thakur |
| Address |
MGM School of Biomedical Sciences, MGMIHS, Kamothe, Navi Mumbai, Raigad, Maharashtra, INDIA-410209 |
| 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 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 Mild/ Moderate Anxiety as assessed by DASS-21/HAM-A |
| Patients |
(1) ICD-10 Condition: F411||Generalized anxiety disorder, |
|
|
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 |
35.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed by Psychiatrist for anxiety will be included in the study.
Patients screened by DASS-21 score 8 and 9 for mild and 10 to 14 for moderate anxiety, HAM-A scores of less than 17 indicating mild severity, 18–24 mild to moderate severity and PHQ-9 score of 1-4 indicating minimal depression, Gad-7 score 5 to 9 for mild and 10 to 14 for moderate anxiety.
Patients agreed to follow meditation protocol and willing to participate.
|
|
| ExclusionCriteria |
| Details |
Individuals presented with Disorder of Sex Development.
History of convulsion or epilepsy during the last 6 months before the study
History of drug abuse.
Having received any psychiatric or psychological therapies during the month before the study.
Patients having a known history of Schizophrenia, Bipolar disorder, Personality disorder, Anxiety disorder, Mood disorder, Obsessive–compulsive disorder, Dissociative disorder, Panic disorder, Depression and any other severe mental health condition.
Patients with metabolic disorders (diabetes, hypertension, and obesity), need oxygen supply or ventilation support and pregnant women or cancer.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Mean depression scores
2. Mean anxiety scores
3. Mean stress scores
4. PER1, CRY1, and BMAL1 gene expression
5. anxiety-related genes 5-HT2A, FKBP5, and MAOA |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Improved Mental Health: Significant reductions in depression, anxiety, and stress in meditation practitioners.
2. Enhanced Circadian Regulation: Positive effects on circadian rhythm patterns and biological clock regulation through changes in PER1, CRY1, and BMAL1 gene expression meditation practitioners.
3. Altered Gene Expression: Modulation of anxiety-related genes 5-HT2A, FKBP5, and MAOA, potentially reducing anxiety through molecular pathways meditation practitioners.
4. Psychological Well-being: Overall improvements in mental health parameters, highlighting the therapeutic potential of Heartfulness meditation.
5.Integrated Mental-Molecular Impact: Evidence supporting the holistic effects of meditation such as Heartfulness on both psychological states and molecular mechanisms related to mental health.
|
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
15/07/2025 |
| 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="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This prospective, randomized controlled trial
aims to assess the effects of Heartfulness meditation on various psychological
and molecular parameters associated with mental health. With growing global
awareness of the burden of mental health disorders, this study investigates how
a structured meditation practice like Heartfulness can influence both
subjective mental well-being and objective biological markers. The primary aim of the study is to evaluate the potential of
Heartfulness meditation on psychological symptoms such as depression, anxiety,
and stress, as well as on gene expression patterns linked to stress and anxiety
regulation. Secondly, the study will evaluate circadian rhythm patterns and
biological clock alignment through standardized questionnaires and gene
expression. Disruptions in circadian rhythm are known to contribute to mental
health disorders, and meditation has been suggested to help restore rhythm synchrony.
Recent research has shown that lifestyle factors,
including meditation, can lead to epigenetic changes such as heritable changes
in gene activity without alterations in the DNA sequence itself.
Mindfulness-based interventions have been linked to reduced expression of
pro-inflammatory genes and enhanced regulation of stress-responsive genes.
However, there is limited data on Heartfulness meditation. By bridging psychometric assessments with
molecular biology, this study aims to provide holistic insights into the potential
of Heartfulness meditation. The findings could significantly contribute to the
field of mind-body medicine by identifying biological mechanisms through which
meditation improves mental health and restores circadian balance. Ultimately,
the research could support the integration of meditative practices into
mainstream mental health care, offering non-pharmacological options for stress
and anxiety management.
|