| CTRI Number |
CTRI/2022/01/039231 [Registered on: 07/01/2022] Trial Registered Prospectively |
| Last Modified On: |
07/06/2023 |
| 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
|
Effect of different Yoga breathing techniques on Blood pressure in adults with normal blood pressure |
|
Scientific Title of Study
|
Immediate Hemodynamic changes on performing slow uninostril and alternate nostril breathing pranayamas in normotensive adults |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vikram Pai |
| Designation |
Medical Officer (AYUSH) Yoga |
| Affiliation |
AIIMS, Raipur |
| Address |
Dept of Yoga & Naturopathy
AIIMS, Raipur
GE Road, Tatibandh, Raipur
Raipur CHHATTISGARH 492099 India |
| Phone |
8076431586 |
| Fax |
|
| Email |
drbvipai@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Vikram Pai |
| Designation |
Medical Officer (AYUSH) Yoga |
| Affiliation |
AIIMS, Raipur |
| Address |
Dept of Yoga & Naturopathy
AIIMS, Raipur
GE Road, Tatibandh, Raipur
Raipur CHHATTISGARH 492099 India |
| Phone |
8076431586 |
| Fax |
|
| Email |
drbvipai@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Vikram Pai |
| Designation |
Medical Officer (AYUSH) Yoga |
| Affiliation |
AIIMS, Raipur |
| Address |
Dept of Yoga & Naturopathy
AIIMS, Raipur
GE Road, Tatibandh, Raipur
Raipur CHHATTISGARH 492099 India |
| Phone |
8076431586 |
| Fax |
|
| Email |
drbvipai@gmail.com |
|
|
Source of Monetary or Material Support
|
| The Director,
All India Institute of Medical Sciences Raipur
GE Road, Tatibandh, Raipur 492099. Chhattisgarh, India |
|
|
Primary Sponsor
|
| Name |
AIIMS Raipur |
| Address |
Dept of Yoga & Naturopathy
AIIMS Raipur
GE Road, Tatibandh |
| Type of Sponsor |
Government medical college |
|
|
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 Vikram Pai |
All India Institute of Medical Sciences Raipur |
Dept of Yoga & Naturopathy
AIIMS, Raipur
GE Road Tatibandh Raipur CHHATTISGARH |
8076431586
drbvipai@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee AIIMS Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normotensive healthy human volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Breathing techniques |
10 minutes (60 rounds) of Right Uninostril breathing, Left Uninostril breathing, Alternate nostril breathing preceded and followed by 5 minutes rest |
| Comparator Agent |
Rest |
20 minutes Resting in sitting position with normal breathing |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
People within 25 to 50 years age.
Normotensive people.
|
|
| ExclusionCriteria |
| Details |
People suffering from any acute or chronic illnesses undergoing or requiring medical management.
People with Smoking and/or substance addiction.
People diagnosed and undergoing treatment for Psychiatric, ENT and Endocrinal disorders
Incidentally detected Hypertensives.
Diagnosed case of Deviated Nasal Septum (DNS)
Regular Yoga practitioners for more than 3 months.
|
|
|
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 |
The results will define the physiological effects of slow yogic uninostril and alternate nostril breathing pranayamas on blood pressure and pulse rate.
|
1. Baseline after 5 minutes rest,
2. 5 minutes/30 rounds of breathing practice,
3. after 10 minutes/60 rounds of breathing practice and
4. after 15 minutes/ 5 minutes rest after practice |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
If results are positive, the efficacy of slow yogic uninostril and alternate nostril breathing pranayamas can be tested in hypertensive patients and thereby explore the possibility to use it as an adjuvant therapy in treatment of essential hypertension.
|
1. Baseline after 5 minutes rest,
2. 5 minutes/30 rounds of breathing practice,
3. after 10 minutes/60 rounds of breathing practice and
4. after 15 minutes/ 5 minutes rest after practice
|
|
|
Target Sample Size
|
Total Sample Size="132" Sample Size from India="132"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="132" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/01/2022 |
| Date of Study Completion (India) |
29/06/2022 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Yoga is an ancient Indian art and science of
maintaining health and wellbeing. Pranayamas are the breathing techniques
explained in yoga. Pranayamas have been reported to have beneficial effects on
health by reducing psychosocial stress which are mediated through improvement
of autonomic functions[1,7,9]. Recently, it has been seen that psychosocial
stress levels are on the rise in modern society due to change in lifestyle.
Chronic psychosocial stress is associated with increased the risk of Non
communicable diseases including Hypertension[21]. Many studies have
shown that the slow breathing practices can cause modest reduction in blood
pressure[22-24]. Earlier, studies have been conducted on immediate
effects of Uninostril and alternate nostril breathing on Blood pressure. They
suggest differential nostril breathing produces distinct autonomic changes[6,14].
But they involved regular practitioners of Yoga[6,14]. This study
intends to study the immediate hemodynamic effects of slow uninostril and slow
alternate nostric Yoga breathing practices on 132 subjects. This study is to
assess the physiological effects of certain modified Yoga breathing practices
on hemodynamic parameters like Systolic Blood Pressure (SBP), Diastolic Blood
Pressure (DBP), Mean Pressure (MP) and Pulse Rate (PR), in healthy adults who
are non regular practitioners of Yoga. In this study, slow Yogic Uninostril
breathing practices like Chandra-Anulom vilom (CAV) or Left Nostril breathing,
Surya-Anulom vilom (SAV) or Right Nostril breathing, Anulom-Vilom (AV) or
Alternate nostril breathing are used as intervention. |