FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/11/037922 [Registered on: 10/11/2021] Trial Registered Prospectively
Last Modified On: 01/03/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Effect of yoga breathing techniques on brain activity 
Scientific Title of Study   Effect of yoga breathing techniques on thalamo-cortical activity 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shirley Telles  
Designation  Director of Research 
Affiliation  Patanjali Research Foundation (Trust) 
Address  Department of Yoga Research, 2nd floor, Sadbhawana Building, Patanjali Research Foundation (Trust), Patanjali Yogpeeth Phase 1, Bahadrabad,

Hardwar
UTTARANCHAL
249405
India 
Phone  9897963254  
Fax    
Email  office@prft.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Shirley Telles  
Designation  Director of Research 
Affiliation  Patanjali Research Foundation (Trust) 
Address  Department of Yoga Research, 2nd floor, Sadbhawana Building, Patanjali Research Foundation (Trust), Patanjali Yogpeeth Phase 1, Bahadrabad,

Hardwar
UTTARANCHAL
249405
India 
Phone  9897963254  
Fax    
Email  office@prft.in  
 
Details of Contact Person
Public Query  
Name  Dr Shirley Telles  
Designation  Director of Research 
Affiliation  Patanjali Research Foundation (Trust) 
Address  Department of Yoga Research, 2nd floor, Sadbhawana Building, Patanjali Research Foundation (Trust), Patanjali Yogpeeth Phase 1, Bahadrabad,

Hardwar
UTTARANCHAL
249405
India 
Phone  9897963254  
Fax    
Email  office@prft.in  
 
Source of Monetary or Material Support  
Patanjali Research Foundation (Trust), Patanjali Yogpeeth Phase 1, Bahadrabad, Haridwar, Uttrakhand, India, 249405 
 
Primary Sponsor  
Name  Patanjali Research Foundation Trust 
Address  Patanjali Yogpeeth Phase 1, Bahadrabad, Haridwar, Uttrakhand, India, 249405 
Type of Sponsor  Research institution 
 
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 Shirley Telles  Patanjali Research Foundation (Trust)  Clinical Neurophysiology Lab, Department of Yoga Research, 2nd floor, Sadbhawana Building, Patanjali Research Foundation (Trust), Patanjali Yogpeeth Phase 1, Bahadrabad, Haridwar, Uttrakhand, 249405, India
Hardwar
UTTARANCHAL 		 9897963254

office@prft.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of Department of Yoga Research, Patanjali Research Foundation  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Participants with normal health of both gender (based on Semi structured interview for health conditions)  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Breath awareness (Active control session)  (i) Pre (5 minutes), (ii) During (18 minutes with three epochs of 5 minutes with one minute rest between two consecutive epochs) and (iii) Post (5 minutes). 
Intervention  High frequency yoga breathing (Kapalabhati pranayama)  (i) Pre (5 minutes), (ii) During intervention (18 minutes with three epochs of 5 minutes with one minute rest between two consecutive epochs) and (iii) Post (5 minutes). 
Intervention  Humming bee breathing (Bhramari pranayama)  (i) Pre (5 minutes), (ii) During intervention (18 minutes with three epochs of 5 minutes with one minute rest between two consecutive epochs) and (iii) Post (5 minutes). 
Comparator Agent  Quiet sitting (Control session)  (i) Pre (5 minutes), (ii) During (18 minutes with three epochs of 5 minutes with one minute rest between two consecutive epochs) and (iii) Post (5 minutes). 
Intervention  Yoga bellows-type breathing (Bhastrika pranayama)  (i) Pre (5 minutes), (ii) During intervention (18 minutes with three epochs of 5 minutes with one minute rest between two consecutive epochs) and (iii) Post (5 minutes). 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1. Healthy adults (health status is based on a semi-structured interview)

2. Minimum yoga experience 3 months
 
 
ExclusionCriteria 
Details  1. Person having any health conditions which could make it unsafe to practice of any pranayama. The health conditions unsafe to practice high frequency yoga breathing and yoga bellows-type breathing are epilepsy, hypertension, history of stroke, gastric ulcer, hernia, glaucoma, recent abdominal surgery and pregnancy. Tinnitus and an active ear infection are the conditions which are unsafe to practice humming bee breathing.

2. Person with extra systole based on electrocardiogram (ECG)

3. Person with abnormal evoked response based on mid-latency auditory response (MLR)

4. Having any type of skin allergy

5. Consumption of alcohol, tobacco, caffeine and also intake of medication (before and during the days of recording)



 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Middle latency auditory evoked response (MLR),

2. Heart rate variability (HRV) and

3. Respiration rate (RR).

 		 In each session there will be (i) Baseline (5 minutes), (ii) During (18 minutes with three epochs of 5 minutes with one minute rest between two consecutive epochs) and (iii) Post (5 minutes). 
 
Secondary Outcome  
Outcome  TimePoints 
1. Mood using Brief mood introspection scale (BMIS),

2. Symptoms of hyperventilation syndrome using Nijmegen questionnaire (NQ) and

3. Quality of intervention using Visual analogue scale (VAS). 		 1. For BMIS, in each session there will be:(i) Baseline and (ii) Post assessment (after 18 minutes of intervention).

2. For NQ and VAS, in each session there will be: (i) Only post assessment (after 18 minutes of intervention).
 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "42"
Final Enrollment numbers achieved (India)="42" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/12/2021 
Date of Study Completion (India) 17/10/2023 
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   The result of this study will be reported/published in internationally recognized databases (such as: PubMed or Scopus or Web of Science etc.).  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The aim of this study is to assess the effects of (i) Yoga bellows-type breathing (bhastrika pranayama), (ii) High frequency yoga breathing (kapalabhati pranayama) and (iii) Humming bee breathing (bhramari pranayama) techniques on thalamo-cortical and autonomic activity in normal healthy participants. Assessments used in this study are: (i) Middle latency auditory evoked response (MLR) for thalamo-cortical activity using Nicolet EDX system U.S.A., (ii) Heart rate variability (HRV) and respiration rate (RR) for involvement of autonomic nervous system using MP 45 Biopac Student Lab, BIOPAC System Inc, U.S.A, (iii) The brief mood introspection scale (BMIS) for mood, (iv) Nijmegen questionnaire (NQ) for breathing pattern and (v) Visual analogue scale (VAS) for interventional quality. This study will help to understand if the characteristics of respiration modify the thalamo-cortical activity as well as involvement of autonomic nervous system to modify this.

 
Close