| CTRI Number |
CTRI/2025/09/094443 [Registered on: 09/09/2025] Trial Registered Prospectively |
| Last Modified On: |
19/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Checking the effectiveness of slow breathing exercises on randomly selected clients in a community setting who have high blood pressure by measuring pulse rate, blood pressure. |
|
Scientific Title of Study
|
Effect of supplementing slow breathing exercise on cardiovascular parameters among the adults with hypertension -Community Based Randomized Control 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 |
Susmita Mondal |
| Designation |
M. Sc Community Health Nursing student |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Jawaharlal Institute of Postgraduate Medical Education and Research
Old Curie Hostel,
Room no- 217
JIPMER Campus Rd, Gorimedu,
Dhanvantari Nagar,
Puducherry, 605006.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8116807362 |
| Fax |
|
| Email |
susmitamn1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vembu K |
| Designation |
Tutor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Jawaharlal Institute of Postgraduate Medical Education and Research
College of Nursing
JIPMER Campus Rd, Gorimedu,
Dhanvantari Nagar,
Puducherry, 605006.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7845506589 |
| Fax |
|
| Email |
vkjipmer11@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vembu K |
| Designation |
Tutor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Jawaharlal Institute of Postgraduate Medical Education and Research
College of Nursing
JIPMER Campus Rd, Gorimedu,
Dhanvantari Nagar,
Puducherry, 605006.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7845506589 |
| Fax |
|
| Email |
vkjipmer11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Intramural Fund Committee, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), JIPMER Campus Rd, Gorimedu,
Dhanvantari Nagar, Puducherry, Pin Code- 605006, India |
|
|
Primary Sponsor
|
| Name |
Jawaharlal institute of postgraduate medical education and research |
| Address |
Intramural fund committee, Jawaharlal institute of postgraduate medical education and research, puducherry, 605006 |
| 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 Vembu K |
Urban PHC (Will be Selected Randomly) |
Puducherry
Pondicherry
PONDICHERRY |
7845506589
vkjipmer11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Interventional Studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, (2) ICD-10 Condition: I10-I16||Hypertensive diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Slow breathing exercise |
Slow breathing exercise includes Om chanting for 2minute, then nadisodhana, chandranadi pranayama and bhramari pranayama each for 4minute, then deep relaxation for 15 minutes for 8weeks. |
| Comparator Agent |
standard care provided by PHC |
Only standard care will be taken, which will be provided by the health center for 8 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Study participants diagnosed with hypertension with either gender on medications and age ranging from 18-60 years.
experimental group participants willing to do slow breathing exercises.
Receiving antihypertensive medication regularly for at least one year.
Clients those who are having access to video watch.
|
|
| ExclusionCriteria |
| Details |
Individuals who have a history of known cardiac disease or those who have undergone bypass surgery.
Adults who practice slow breathing exercise regularly.
Adults engaged in other biofeedback techniques previously or currently.
Uncontrolled hypertension. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study focuses on significantly reducing systolic and diastolic blood pressure among hypertensive adults who practice slow breathing exercises for 8 weeks. This intervention is anticipated to improve autonomic regulation by increasing parasympathetic activity and reducing sympathetic tone, enhancing baroreflex sensitivity. Additionally, participants may experience improved heart rate variability, reduced resting heart rate, and better respiratory efficiency. |
Outcome will be assessed at baseline, 4weeks, and 8weeks after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Slow breathing as a cost-effective method for hypertension management in community settings. |
Outcome will be assessed at baseline, 4weeks, & 8weeks after starting the data collection. |
|
|
Target Sample Size
|
Total Sample Size="144"
Sample Size from India="144"
Final Enrollment numbers achieved (Total)= "144"
Final Enrollment numbers achieved (India)="144" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/09/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
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
|
This is a randomized control trial study focusing on reducing the blood pressure among adults with hypertension by using slow breathing exercises like Om chanting, chandranadi pranayama, Nadi shodhana pranama, and Bhramari pranayama each for 4 minutes then 15 15-minute deep relaxation technique. 4 and 8 weeks after giving the intervention follow up will be done to see how much blood pressure is under control. |