| CTRI Number |
CTRI/2024/04/065226 [Registered on: 04/04/2024] Trial Registered Prospectively |
| Last Modified On: |
30/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Immediate effect of Nadanusandhana Meditation on Autonomic Variables |
|
Scientific Title of Study
|
Immediate effect of nadanusandhana meditation on autonomic variables among patients with hypertension- A ranzomized controlled trial |
| 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 Neeraj Dubey |
| Designation |
MD yoga Scholar |
| Affiliation |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy Yogic Sciences, Meerut |
| Address |
Department of PG studies, Maharishi Aurobindo Subharti College and Hospital of Naturopathy Yogic Sciences, Swami Vivekanand Subharti University
Meerut
UTTAR PRADESH
250005
India |
| Phone |
8764025773 |
| Fax |
|
| Email |
neeraj26dubey@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhiren Ajit Nair |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy Yogic Sciences, Meerut |
| Address |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy Yogic Sciences, Swami Vivekanand Subharti University
Meerut
UTTAR PRADESH
250005
India |
| Phone |
7899143619 |
| Fax |
|
| Email |
danny.a.nair@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhay M Shankaregowda |
| Designation |
Principal |
| Affiliation |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy Yogic Sciences, Meerut |
| Address |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy Yogic Sciences, Swami Vivekanand Subharti University
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9448300347 |
| Fax |
|
| Email |
naturopathy@subharti.org |
|
|
Source of Monetary or Material Support
|
| Dr Neeraj Dubey self financed, Swami Vivekanand Subharti University and Chhatrapati Shivaji Subharti Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Neeraj Dubey |
| Address |
Swami Vivekanand Subharti University, Subhartipuram NH 58 Delhi Haridwar Bypass Road, Meerut |
| Type of Sponsor |
Other [Self Sponsored] |
|
|
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 Neeraj Dubey |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences |
Swami Vivekanand Subharti University Subhartipuram NH58 Delhi Haridwar Bypass Road
Meerut
UTTAR PRADESH |
8764025773
neeraj26dubey@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University Ethics Committee Medical |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I159||Secondary hypertension, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
Participants in the control group will practice Supine rest for the same duration, i.e., 15 min in Shavasana with closed eyes and palms facing roof |
| Intervention |
Nadanusandhana Meditation |
Different sounds like A, U, M, and AUM are produced to create a fine resonance throughout the body.
Each patient will receive the intervention for 15 minutes. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients willing to participate
2 Hypertension stage 1 and stage 2 patients who are
on regular antihypertensive medication (
Losartan, Metaprolol, etc.)
3 Patients with a history of HTN ≥5 years.
|
|
| ExclusionCriteria |
| Details |
1 Patients with resistance HTN (uncontrolled HTN,
on more than two antihypertensive medications).
2 Cardiac arrhythmia, Chronic Respiratory
problems (history of asthma, COPD, angioplasty,
recent open-Heart surgery).
3 Any kind of Mental illness.
4 Neurological disorders.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Heart Rate Variability |
The assessments will be taken immediately before and after the intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Blood Pressure
2.Pulse rate |
The assessments will be taken immediately before and after the intervention |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
Final Enrollment numbers achieved (Total)= "102"
Final Enrollment numbers achieved (India)="102" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/04/2024 |
| Date of Study Completion (India) |
30/07/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/07/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
A Randomized control trial study aims to explore the Immediate Effect of Nadanusandhana Meditation on Autonomic Variables Among Patients with Hypertension. This study is allocated in two groups, the intervention group will take nadanusandhana meditation for 15 minutes and control group will take supine rest for 15 minutes. Data will examined pre intervention and post intervention. Nadanusandhana meditation different sounds like A, U, M, and AUM are emphatically produced to create a fine resonance throughout the body. These resonances serve as stimuli, and the post-resonance stillness develops awareness and let’s go of even the most minute tensions. To get a fine resonance, try adjusting the pitch while making the various sounds (A, U, M, and AUM). This study will be a core strength decreases blood pressure among hypertensive patients. 80% data collection has been done. |