| CTRI Number |
CTRI/2025/03/083044 [Registered on: 21/03/2025] Trial Registered Prospectively |
| Last Modified On: |
07/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study on the effects of pranayama and relaxation on blood pressure among hypertensive patients. |
|
Scientific Title of Study
|
Effect of Pranayama and Yogic Relaxation Techniques on Blood Pressure among Hypertensives: A Randomized 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 Shubhashree A N |
| Designation |
Master of public health |
| Affiliation |
JSS Academy of higher education and research |
| Address |
School of Public Health department, JSS Medical College, division JS Academy of higher education and research
Sri Shivarathreeshwara Nagara Karnataka India
Mysore
KARNATAKA
570004
India |
| Phone |
6366472097 |
| Fax |
|
| Email |
shubharnreddy12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil Kumar D |
| Designation |
Professor and HOD of Department Community medicine |
| Affiliation |
JSS Academy of higher education and research |
| Address |
Department of Community medicine,JSS Medical College, division JSS academy of higher education and research Sri Shivarathreeshwara Nagara, Karnataka India
Mysore
KARNATAKA
570004
India |
| Phone |
6366366663 |
| Fax |
|
| Email |
sunilkumard@jssuni.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shubhashree A N |
| Designation |
Masters in public health student |
| Affiliation |
JSS Academy of higher education and research |
| Address |
School of Public Health department, JSS Medical College, division JSS academy of higher education and research
Sri Shivarathreeshwara nagara Mysore.
Mysore
KARNATAKA
570004
India |
| Phone |
6366472097 |
| Fax |
|
| Email |
shubharnreddy12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Study is self funded and venue for pranayama intervention provided by JSS urban health centre |
|
|
Primary Sponsor
|
| Name |
Dr Shubhashree A N |
| Address |
Masters of public health,School of public health department JSS Medical college division JSS academy of higher education and research, Shivarathreeshwara nagara 570015 Mysore, Karnataka, India |
| 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 Shubhashree A N |
JSS Urban health centre Medar block |
8JHV+M54, JSS urban health centre under department of Community medicine,JSS medical College.
3rd Main Rd, Medar Block, Mysuru, Karnataka 570021
Mysore
KARNATAKA |
6366472097
shubharnreddy12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS academy of higher education and research |
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 |
| Comparator Agent |
routine medical care |
65 participants will be comparitive group Participants who are on regular medications for hypertension and routine care . no intervention is given for control group |
| Intervention |
Pranayama and Yogic relaxation techniques |
65 participants will undergo Sheetali/Sheetkari pranayama (2 minutes)
Nadishodhana pranayama (2 minutes)
Brahmari pranayama (2 minutes)
Mind sound resonance technique(30 minutes)
Deep relaxation technique(5 minutes) These will be given for intervention group for 45 minutes duration for 1 month period with 4 sessions per week |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
-Participants with essential/primary hypertension
-Hypertensives aged 30-70 years diagnosed from more than 1 year
-Participants with Elevated,grade 1 and 2 hypertension
|
|
| ExclusionCriteria |
| Details |
-Participants with secondary/non essential hypertension
-Participants who are on regular yoga practice more than 1 month
-Cognitively impaired, pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in blood pressure levels among experimental group measured before and after the intervention |
Baseline before intervention and at 4 weeks post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
- Changes in Depression, anxiety stress levels in both experimental and control group
- Quality of life in both groups |
Baseline before intervention and at 4 weeks post intervention |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
31/03/2025 |
| 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="0"
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
|
Title: Effect of pranayama and yogic relaxation techniques on blood pressure among hypertensives: A randomized controlled trial objective: to evaluate the effect of pranayama and yogic relaxation techniques on blood pressure among the intervention group. and to assess and compare the depression, anxiety, stress, and quality of life scores in both groups. design: a randomized controlled trial with two groups. intervention group receiving pranayama and yogic relaxation techniques for one month and a control group following routine care. Blood pressure measurements and depression, anxiety, stress, and quality of life scores will be taken at baseline and at the end of the one-month intervention. Participants: Hypertensives aged 30-70 years diagnosed for more than one month. Participants with essential/primary hypertension Participants with elevated, grade 1, and grade 2 hypertension. Intervention: The intervention group will undergo pranayama (sheetali/sheetkari, nadishodhana, and brahmari) yogic relaxation techniques (mind sound resonance techniques and deep relaxation techniques) for 45 minutes weekly for 4 sessions for 1 month. outcomes: The primary outcome is changes in blood pressure before and after the intervention. The secondary outcome is changes in the depression, anxiety, stress, and quality of life scores in both experimental and control groups. Significance: The study aims to explore non-pharmacological approaches to hypertension management, which may serve as complementary therapies for patients seeking holistic health practices.
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