| CTRI Number |
CTRI/2018/08/015215 [Registered on: 07/08/2018] Trial Registered Prospectively |
| Last Modified On: |
04/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Yoga for Cardiovascular functions |
|
Scientific Title of Study
|
Effect of Bhramari Pranayama on Cardiovascular Functions and Heart Rate Variability in Patients with Hypertension |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gautam Sharma |
| Designation |
Professor Incharge |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), |
| Address |
Room No. 7004, 7th Floor, Convergence Block, Center for Integrative Medicine (CIMR),
South West
DELHI
110029
India |
| Phone |
01126549326 |
| Fax |
|
| Email |
drgautamsharma12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gautam Sharma |
| Designation |
Professor Incharge |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), |
| Address |
Room No. 7004, 7th Floor, Convergence Block, Center for Integrative Medicine (CIMR),
South West
DELHI
110029
India |
| Phone |
01126549326 |
| Fax |
|
| Email |
drgautamsharma12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gautam Sharma |
| Designation |
Professor Incharge |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), |
| Address |
Room No. 7004, 7th Floor, Convergence Block, Center for Integrative Medicine (CIMR),
South West
DELHI
110029
India |
| Phone |
01126549326 |
| Fax |
|
| Email |
drgautamsharma12@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029 |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 Gautam Sharma |
All India Institute of Medical Sciences |
Room No. 7004, 7th Floor, Convergence Block, Center for Integrative Medicine and Research(CIMR)
South West
DELHI |
01126549326
drgautamsharma12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bhramari pranayama |
Subjects will be asked to perform Bhramari pranayama by inhaling through both nostrils and while exhaling should produce the sound of humming bee for the duration of 5 minutes. Intervention will be given only one day. |
| Comparator Agent |
Producing the sound of "SSSS" |
Subjects will be asked to sit in a comfortable posture and to inhale deeply and then while exhaling should produce the sound of ‘SSSS’ for the duration of 5 minutes. Comparator intervention will be given only one day. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Subject with the history of essential hypertension
2) SBP < 180 mmHg & DBP < 110 mmHg
3) Using < 2 Anti-hypertensive medications
4) Willingness to participate in the study
|
|
| ExclusionCriteria |
| Details |
1) Subject with the history of secondary hypertension and other cardiovascular diseases like coronary artery disease, heart failure, arrhythmia, rheumatic heart diseases and congenital heart diseases.
2) Subjects with the history of renal, neurological, hepatic and pulmonary diseases or complications
3) Subject with the history of Psychiatric disorders
4) Subject underwent yoga for the past 1 month.
5) Subject who is unable to perform Bhramari pranayama.
6) Subjects with irregular and frequent change of hypertensive medications. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Blood pressure |
Baseline (5 minutes before intervention), during (intervention period) and immediately after intervention (for the period of 5 minutes) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| heart rate, Heart rate variability, stoke volume, cardiac output, arterial stiffness and total peripheral resistant |
Baseline (5 minutes before intervention), during intervention (5 minutes) and immediately after intervention (for 5 minutes) |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
03/09/2018 |
| Date of Study Completion (India) |
30/07/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
published in 2021, Explore (NY)
doi:10.10.16/j.explore.2020.03.009 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
· This is a parallel group randomized control study designed to study the effect of Bhramari pranayama on cardiovascular function and heart rate variability in patients with hypertension. Based on the inclusion and exclusion criteria, the patients will be randomized to either study group or control group. Intervention: Study Group: Subjects will be asked to perform Bhramari pranayama by inhaling through both nostrils and while exhaling should produce the sound of humming bee for the duration of 5 minutes in one day only. Control group: Subjects will be asked to sit in a comfortable posture and to inhale deeply and then while exhaling should produce the sound of ‘SSSS’ for the duration of 5 minutes in one day only. Assessment: After collecting the demographic details, the following outcome measures will be assessed before, during and immediately after the intervention. Cardiovascular Functions: The cardiovascular variables such as systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), heart rate (HR), stoke volume (SV), cardiac output (CO), arterial stiffness and total peripheral resistant (TPR) will be assessed in sitting position using non-invasive blood pressure monitoring system (Ambulatory Blood Pressure Systems, Germany). A Non-invasive blood pressure cuff will be placed on the upper arm of the left hand at the level of the heart and the marker on the cuff will be directly above the brachial artery. The hand will be placed at the knee and flexed at the elbow. Heart rate variability: Heart rate variability will be derived from electrocardiogram taken using Holter monitoring system. Follow up: Since this is study is designed to study the immediate effect, the subjects will not be followed up. |