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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 

 
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