| CTRI Number |
CTRI/2025/07/090274 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
04/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Nadi Shodhana Pranayama in Hypertensive Patients, HRV as parameter. |
|
Scientific Title of Study
|
Effect of 10 days of nadi shodhana pranayama practice on heart rate variability in patient with primary hypertension- A Radomized 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 |
Varsha Dhama |
| Designation |
Intern |
| Affiliation |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences |
| Address |
Department of Post Graduate Studies Subharti College
and Hospital of Naturopathy and Yogic Sciences Swami
Vivekanand Subharti University Subhartipuram Meerut
UTTAR PRADESH India Meerut
Department of Post Graduate Studies Subharti College
and Hospital of Naturopathy and Yogic Sciences Swami
Vivekanand Subharti University Subhartipuram Meerut
UTTAR PRADESH India Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
8171454831 |
| Fax |
|
| Email |
varshadhama2001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nair Dhiren Ajit |
| Designation |
Assistant professor |
| Affiliation |
|
| Address |
Department of Post Graduate Studies Subharti College
and Hospital of Naturopathy and Yogic Sciences Swami
Vivekanand Subharti University Subhartipuram Meerut
UTTAR PRADESH India Meerut
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 and Dean |
| Affiliation |
|
| Address |
Department of Post Graduate Studies Subharti College
and Hospital of Naturopathy and Yogic Sciences Swami
Vivekanand Subharti University Subhartipuram Meerut
UTTAR PRADESH India Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9639010531 |
| Fax |
|
| Email |
naturopathy@subharti.org |
|
|
Source of Monetary or Material Support
|
| Varsha Dhama self financed,Swami Vivekananda Subharti University and Chhatrapati Shivaji Subharti Hospital, Meerut, Uttar pradesh, India 250005 |
|
|
Primary Sponsor
|
| Name |
Varsha Dhama |
| Address |
Maharishi Aurobindo Subharti College and Hospital of
Naturopathy and Yogic Sciences Swami Vivekanand
Subharti University Subhartipuram NH-58 Delhi Haridwar
Bypass Road Uttar Pradesh 250005 |
| 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 Varsha Dhama |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences |
Department of Post Graduate Studies Subharti College
and Hospital of Naturopathy and Yogic Sciences Swami
Vivekanand Subharti University, Subhartipuram Meerut,
UTTAR PRADESH, India 250005
Meerut
UTTAR PRADESH |
8171454831
varshadhama2001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University Ethics Committee Medical Swami Vivekanand Subharti University |
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 |
Nadi Shodhana |
For twenty minutes, Group 1 conducted Nadi Shodhana Pranayama. Participants were instructed to sit in "Sukhasana" for the practice. The following actions were then required of the participants: Put on the Chin/Gyan Mudra in your left hand and the Nasikagra Mudra on your right. Breathe in and out gently and deeply through both nostrils. Shut the right nostril and take a slow, quiet breath through the left. When the intake is finished, seal your left nostril and release the air as slowly as you can through your right. Exhale fully, then take a slow, quiet breath through your right nostril. Exhale quietly and softly after closing your right nostril and opening your left. Continue by taking another breath through the same nostril. |
| Comparator Agent |
Regular Breathing |
Without any conscious control over respiratory depth or rate, the subjects of the non-pranayama group sat in a similar position and breathed regularly and rhythmically as the volunteers of the Pranayama group |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Primary hypertension under medication.
2.Willingness to participate in the study. |
|
| ExclusionCriteria |
| Details |
1.Secondary hypertension
2.Valvular heart disease,
3.Pericarditis/myocarditis,
4.Heart failure with EF 35%, CABG, PTCA with or without stenting.
5.Regular use of medication for any disease
Habit of tobacco, chewing, smoking, and alcohol
6.Engagement in any pranayama/exercise/sports program for the past 6 weeks. |
|
|
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 assessment will be taken at baseline and after 10 days of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Blood pressure
Pulse rate
Respiratory rate
Meal arterial pressure |
The assessment will be taken baseline & after 10 days intervention |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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)
|
28/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
28/07/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
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 is an Randomized controlled Trial to find the effect of 10 Days Nadi Shodhana Pranyama on Heart rate variability, Blood pressure, pulse rate , Respiratory rate and mean arterial pressure and to test the hypothesis of Nadi Shodhana Pranayama measured by the mean difference in HRV,BP,PR,RR and MAP among Hypertensive patients. |