| CTRI Number |
CTRI/2022/09/045543 [Registered on: 15/09/2022] Trial Registered Prospectively |
| Last Modified On: |
07/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Heartfulness Meditation] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to access the effect of Heartfulness meditation practices on blood vessel function in heart attack patients. |
|
Scientific Title of Study
|
Effect of Heartfulness meditation practices on endothelial function and inflammation in patients with coronary artery disease. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vijaya Chandra Reddy Konda |
| Designation |
Research Scholar, Department of Cardiology. |
| Affiliation |
Sri Venkateswara Institute of Medical Sciences |
| Address |
Dr Vijaya Chandra Reddy Konda,
Research Scholar,
Department of Cardiology,
Sri Venkateswara Institute of Medical Sciences,
Alipiri Road,
Tirupati,
Andhra Pradesh.
Dr Vijaya Chandra Reddy Konda,
Research Scholar,
Department of Cardiology,
Sri Venkateswara Institute of Medical Sciences,
Alipiri Road,
Tirupati,
Andhra Pradesh.
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9949054199 |
| Fax |
|
| Email |
vijayachandrareddy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Vanajakshamma |
| Designation |
Professor, Department of Cardiology |
| Affiliation |
Sri Venkateswara Institute of Medical Sciences |
| Address |
Dr V. Vanajakshamma,
Professor,
Department of Cardiology,
Sri Venkateswara Institute of Medical Sciences,
Alipiri Road, Tirupati,
Andhra Pradesh.
Dr V. Vanajakshamma,
Professor,
Department of Cardiology,
Sri Venkateswara Institute of Medical Sciences,
Alipiri Road, Tirupati,
Andhra Pradesh.
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9493547668 |
| Fax |
|
| Email |
vanajavelam1966@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijaya Chandra Reddy Konda |
| Designation |
Research Scholar, Department of Cardiology. |
| Affiliation |
Sri Venkateswara Institute of Medical Sciences |
| Address |
Dr Vijaya Chandra Reddy Konda,
Research Scholar,
Department of Cardiology,
Sri Venkateswara Institute of Medical Sciences,
Alipiri Road,
Tirupati,
Andhra Pradesh.
Dr Vijaya Chandra Reddy Konda,
Research Scholar,
Department of Cardiology,
Sri Venkateswara Institute of Medical Sciences,
Alipiri Road,
Tirupati,
Andhra Pradesh.
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9949054199 |
| Fax |
|
| Email |
vijayachandrareddy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Venkateswara Institute of Medical Sciences, Alipiri Road, Tirupati, Andhra Pradesh . PIN: 517507 |
|
|
Primary Sponsor
|
| Name |
Sri Balaji Arogya Varaprasadini Scheme |
| Address |
Sri Venkateswara Institute of Medical Sciences,
Alipiri Road, Tirupati,
Andhra Pradesh |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Vijaya Chandra Reddy Konda |
Sri Venkateswara Institute of Medical Sciences |
Department of Cardiology,
Sri Venkateswara Institute of Medical Sciences,
Alipiri Road, Tirupati,
Andhra Pradesh.
PIN: 517507
Chittoor
ANDHRA PRADESH |
9949054199
vijayachandrareddy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Venkateswara Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Heartfulness meditation practices |
Patients enrolled in study are introduced to the 3 day heartfulness mediation process which is being conducted for a duration of 1 hour daily on three consecutive days by a certified heartfulness meditation trainer. These 3 day sessions enable the patients to practice the key elements of heartfulness meditation – mediation, cleaning and prayer.
Patients will be asked to follow the following components of Heartfulness meditation practice daily for a period of four months:
1. Morning Meditation at home for a minimum of atleast 30 minutes that can be extended up to 60 minutes to have a good start for the day.
2. Evening ‘Cleaning’ session at home for a minimum of 20 minutes and not to extend beyond 30 minutes at the end of the day to help clear work stress and day’s impressions and provide inner refreshment.
3. Night bedtime Prayer-Meditation at home for at least 10 minutes extending up to 15 minutes to facilitate a deeper relaxed sleep and act as a better preparation for the following day.
4. Participate in a one-on-one individual meditation session with a certified trainer remotely for at least once in every week (7 days).
The total duration of the intervention is for four months.
Baseline parameters before start of intervention will be compared with those at the end of intervention period of four months. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
INCLUSION CRITERIA:
All patients of either sex with age >30 years and < 65 years with documented evidence of significant and stable coronary artery disease who:
1. Did not undergone percutaneous coronary revascularization
2. Did not undergone coronary artery bypass grafting (CABG)
3. Are willing to participate in the study |
|
| ExclusionCriteria |
| Details |
EXCLUSION CRITERIA:
1. Patients who had already undergone percutaneous coronary revascularization or CABG
2. Patients with acute coronary syndrome.
3. Patients with significant left main coronary artery stenosis.
4. Patients with ejection fraction < 40%.
5. Patients with moderate to severe ischaemic mitral regurgitation.
6. Patients with moderate to severe pulmonary arterial hypertension
7. Patients with structural heart disease
8. Patients with decompensated heart failure
9. Patients with renal impairment
10. Patients with known malignancies
11. Pregnant women
12. Patients already practicing any form of meditation
13. Patients not willing 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 |
Effect of heartfulness meditation practices for four months compared to baseline (before start of intervention) on
1. Change in brachial artery reactivity to flow mediated dilatation
2. Change in blood levels of inflammatory markers - hsCRP and IL-6
3. Change in gene expression of IL-6 gene |
At baseline (before intervention) and at four months after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Effect of heartfulness meditation practices for four months compared to baseline (before start of intervention) on
1. Change in quality of life (QOL) and selected wellbeing parameters using questionnaires – WHOQOL BREF (WHO Quality Of Life Brief questionnaire), Mental Health Continuum Short Form (MHC-SF), Depression, Anxiety & Stress Scale (DASS 21).
2. Change in carotid intimal medial thickness and carotid plaque score by carotid Doppler. |
At baseline (before intervention) and at four months after intervention |
|
|
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)
|
19/09/2022 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a prospective, interventional, single group study with pre-test – post-test design to study the effect of Heartfulness meditation practices on endothelial function and inflammation in patients with coronary artery disease. The study will be conducted in a single centre - Department of Cardiology, Sri Venkateswara Institute of Medical Sciences, Andhra Pradesh. All the patients enrolled in the study will be trained for 3 consecutive days by a certified trainer on heartfulness meditation practices – meditation, cleaning and prayer and will be asked to practice them daily for a period of four months. The primary outcome measures will be changes in brachial artery reactivity to flow mediated dilatation, blood levels of inflammatory markers – hsCRP and IL-6, and gene expression of IL-6 gene. Secondary outcome measures will be changes in quality of life (QOL) and selected wellbeing parameters using questionnaires – WHOQOL BREF (WHO Quality of Life Brief questionnaire), Mental Health Continuum Short Form (MHC-SF), Depression, Anxiety & Stress Scale (DASS 21), and changes in carotid intimal medial thickness & carotid plaque score by carotid Doppler. |