FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
Close