| CTRI Number |
CTRI/2025/09/095095 [Registered on: 19/09/2025] Trial Registered Prospectively |
| Last Modified On: |
27/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of advanced meditation on heart and nervous system in patients with high blood pressure |
|
Scientific Title of Study
|
Effect of advanced meditation technique on Cardio Autonomic Function in patients with Hypertension |
| 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 M D Jeeva |
| Designation |
PG Scholar |
| Affiliation |
Government Yoga and Naturopathy Medical College and Hospital |
| Address |
Dept of yoga, Second floor, Government Yoga and
Naturopathy Medical College and Hospital PG block, Arumbakkam,
Chennai
Chennai
TAMIL NADU
600106
India
Chennai TAMIL NADU 600106 India |
| Phone |
7619656332 |
| Fax |
|
| Email |
drmdjeeva@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr A Mooventhan |
| Designation |
Assistant Medical Officer cum Lecturer, Department of Research |
| Affiliation |
Government Yoga and Naturopathy Medical College and Hospital |
| Address |
Dept of Research, Second floor, Government Yoga and Naturopathy
Medical College and Hospital PG block, Arumbakkam, Chennai
Chennai
TAMIL NADU
600106
India
Chennai TAMIL NADU 600106 India |
| Phone |
9844457496 |
| Fax |
|
| Email |
dr.mooventhan@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr A Mooventhan |
| Designation |
Assistant Medical Officer cum Lecturer, Department of Research |
| Affiliation |
Government Yoga and Naturopathy Medical College and Hospital |
| Address |
Dept of Research, Second floor, Government Yoga and Naturopathy
Medical College and Hospital PG block, Arumbakkam, Chennai
Chennai
TAMIL NADU
600106
India
Chennai TAMIL NADU 600106 India |
| Phone |
9844457496 |
| Fax |
|
| Email |
dr.mooventhan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Yoga and Naturopathy Medical college and Hospital,Arumbakkam,chennai-106 |
|
|
Primary Sponsor
|
| Name |
Government Yoga and Naturopathy Medical college and Hospital |
| Address |
Government Yoga and Naturopathy Medical college and
Hospital,Arumbakkam,chennai 600106 |
| Type of Sponsor |
Government medical college |
|
|
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 M D Jeeva |
Government Yoga and Naturopathy Medical college and Hospital |
2nd floor, Department
of yoga, Post
Graduate block,
Arumbakkam,
Chennai-600106
Chennai
TAMIL NADU Chennai TAMIL NADU |
7619656332
drmdjeeva@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Yoga and Naturopathy Medical College and Hospital,Chennai Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mastering Emotions Technique (MEMT) |
MEMT session of 30 mins 5 days a week for 2 weeks |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
patient with hypertension
patients willing to participate in the study |
|
| ExclusionCriteria |
| Details |
1)Participants with secondary hypertension
2)Participants with hypertensive complications including cardiovascular diseases
3)Individuals who have difficulty lying down in the same position for more than 30 mins.
4)Recent surgeries and deformities of the spine
5)Women during pregnancy and lactation
6)Psychiatric comorbidities (E.g.: Psychosis)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Heart rate variability and heart rate |
Heart rate variability and heart rate will be measured before and after 2 weeks of intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Vedic personality inventory |
Vedic personality inventory will be measured before and after 2 weeks of intervention. |
| systolic blood pressure and diastolic blood pressure |
systolic blood pressure and diastolic blood pressure will be measured before and after 2 weeks of intervention. |
| pulse rate |
pulse rate will be measured before and after 2 weeks of intervention. |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
30/09/2025 |
| 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="5" 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
|
A single arm pre-test and post-test study design will be adopted for this study. Subjects (n=50) will be recruited from Government Yoga and Naturopathy Medical College and hospital who qualify the eligibility criteria. The subjects will undergo MEMT session of 30 mins 5 days a week for 2 weeks. Baseline data will be collected on day one of the intervention and post data will be collected after the last day of intervention. |