| CTRI Number |
CTRI/2012/05/002652 [Registered on: 15/05/2012] Trial Registered Prospectively |
| Last Modified On: |
18/04/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of slow breathing type of Pranayama on Autonomic Nervous System |
|
Scientific Title of Study
|
EFFECT OF SLOW BREATHING ON AUTONOMIC FUNCTION TESTS: RANDOMIZED CONTROLLED TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1130-7335 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Khaled Mohsin Badaam |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College, Aurangabad |
| Address |
Department of Physiology, Government Medical College, Panchakki Road,
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
02402402414 |
| Fax |
02402402418 |
| Email |
khalid_badaam@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Khaled Mohsin Badaam |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College, Aurangabad |
| Address |
Department of Physiology, Government Medical College, Panchakki Road,
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
02402402414 |
| Fax |
02402402418 |
| Email |
khalid_badaam@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Khaled Mohsin Badaam |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College, Aurangabad |
| Address |
Department of Physiology, Government Medical College, Panchakki Road,
MAHARASHTRA
431001
India |
| Phone |
02402402414 |
| Fax |
02402402418 |
| Email |
khalid_badaam@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College, Aurangabad |
|
|
Primary Sponsor
|
| Name |
Dr Khaled Mohsin Badaam |
| Address |
Department of Physiology, Government Medical College,Panchakki Road, Aurangabad |
| Type of Sponsor |
Other [Principal Investigator] |
|
|
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 Khaled Mohsin Badaam |
Government Medical College, Aurangabad |
Department of Physiology,Government Medical College,
Panchakki Road,Aurangabad-431001
Aurangabad
MAHARASHTRA |
02402402414
02402402418
khalid_badaam@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, GMC, Aurangabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Autonomic function abnormalities due to stress causing Hypertension, diabetes, cardiovascular diseases, etc |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CONTROLS |
They will be called at similar timing as slow breathing group but will be engaged in simple exercises
Duration is one month |
| Intervention |
SLOW BREATHING |
Slow breathing exercise will be done with subjects in sitting posture in a well-ventilated room. The exercise will be performed in the following steps:
(i) The volunteers asked to close one of his nostrils (e.g., left nostil) by his thumb and slowly breathe in through the opposite nostril while counting 1 to 6 in his mind in 6 seconds.
(ii) Close other nostril by the index finger (now both nostrils closed) and hold breath for 6 seconds and then open the left nostril to slowly exhale in 6 seconds.
(iii) Breathe in through the left nostrils (with right nostrils closed) over a period of 6 seconds and then close the left nostril (now both nostrils closed) and hold his breath for 6 seconds and then to open the right nostril and exhale over a period of 6 seconds.
These 3 steps completed one breathing cycle, and these cycles will be repeated continuously for half an hour (about 40 cycles) in the morning and half an hour in the evening.
Duration is one month |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Healthy asymptomatic males and females giving consent
Age group: 30 to 40 years.
|
|
| ExclusionCriteria |
| Details |
Not giving consent
Smokers
Any history of cardiac, respiratory, hepatic renal or any major disease
Sportspersons or doing athletic activity
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
AUTONOMIC FUNCTION TESTS
1. Cold Pressor Test
2. Valsalva ratio
3. Sustained Handgrip Test
|
AUTONOMIC FUNCTION TESTS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Blood Pressure |
one month |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/05/2012 |
| 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="1"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The present study is an Interventional open
label Randomized Controlled Trial to compare the effect of slow breathing type of Pranayama on autonomic function tests.Volunteers in 30-40 yrs age group will be randomly allocated to slow breathing group and control group. Autonomic function tests like Cold Pressor Test, Valsalva ratio and Sustained Handgrip
Test will be done before and after the intervention. |