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CTRI Number  CTRI/2025/02/080175 [Registered on: 10/02/2025] Trial Registered Prospectively
Last Modified On: 09/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Bhastrika pranayama to improve cognition in school children  
Scientific Title of Study   A Clinical Evaluation of Bhastrika Pranayama on reaction component of cognitive function among school students- A randomized controlled trial  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr M Surya 
Designation  PG Scholar 
Affiliation  International Institute Of Yoga and Naturopathy Medical Sciences, Chengalpattu. 
Address  184/4,International Institute of Yoga and Naturopathy Medical Sciences, Faculty Block(First floor),Department of Yoga, Kamarajar Nagar, Chengalpattu.

Kancheepuram
TAMIL NADU
603001
India 
Phone  8072777802  
Fax    
Email  surya.bnys@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr A Gayathri 
Designation  Head Of Department I/C(YOGA) 
Affiliation  International Institute Of Yoga and Naturopathy Medical Sciences, Chengalpattu. 
Address  184/4,International Institute of Yoga and Naturopathy Medical Sciences, Faculty Block(First floor),Department of Yoga, Kamarajar Nagar, Chengalpattu.

Kancheepuram
TAMIL NADU
603001
India 
Phone  8124634017  
Fax    
Email  gayathriannamalai93@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr M Surya 
Designation  PG Scholar 
Affiliation  International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu.  
Address  184/4,International Institute of Yoga and Naturopathy Medical Sciences, Faculty Block(First floor),Department of Yoga, Kamarajar Nagar, Chengalpattu.

Kancheepuram
TAMIL NADU
603001
India 
Phone  8072777802  
Fax    
Email  surya.bnys@gmail.com  
 
Source of Monetary or Material Support  
184, International Institute of Yoga and Naturopathy Medical Sciences, Faculty block (First floor),Department of Yoga, Kamarajar nagar, Chengalpattu, Kancheepuram, Tamilnadu-603001. 
 
Primary Sponsor  
Name  Dr M Surya 
Address  184/4, International Institute of Yoga and Naturopathy Medical Sciences, Faculty block (First floor), Department of yoga, Kamarajar Nagar, Chengalpattu  
Type of Sponsor  Other [Self] 
 
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 SURYA M  International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu  184/4,International Institute of Yoga and Naturopathy Medical Sciences, Faculty Block(First floor),Department of Yoga, Kamarajar Nagar, Chengalpattu.
Kancheepuram
TAMIL NADU 		 8072777802

surya.bnys@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
International Institute of Yoga and Naturopathy Medical Sciences,Chengalpattu Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Bhastrika Pranayama practice for Improvement of Cognitive function in School students  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bhastrika Pranayama  School Students will perform Bhastrika Pranayama(Forceful inhalation and exhalation) for 10 minutes continuously for 3 weeks 
Comparator Agent  Breath awareness in sitting position  the participants of this group would be seated with their eyes closed and spine erect. they would be asked to be aware of the movement of air through the nasal passages. the participants were instructed to bring their attention back to their breath if it wandered.  
 
Inclusion Criteria  
Age From  11.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  Student between 11 - 15 years of age, Healthy student with no history of illness at least for the past 6 months, Student’s consent along with his/her parent or guardian’s willing consent 
 
ExclusionCriteria 
Details  Student with recent history of illnesses, cognitive impairment, long standing systemic
illnesses. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assessment of Auditory (ART) and Visual Reaction Time (VRT)  Assessment of Auditory (ART) and Visual Reaction Time (VRT) will be recorded at the baseline and at the end of 3 weeks of practice of Bhastrika pranayama. 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of Need
For Cognition (NCS) Scale 		 Assessment of Need
For Cognition (NCS) Scale will be recorded at the baseline & at the end of 3 weeks of practice of Bhastrika pranayama 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   20/02/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="1"
Days="1" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [surya.bnys@gmail.com].

  6. For how long will this data be available start date provided 01-01-2026 and end date provided 31-12-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Yoga is a Indian philosophical System which combines physical postures, rhythmic breathing, and meditation for holistic mind-body benefits. A study by Kanchibhotla et al. (2021) found traditional practices like Pranayama and Meditation significantly improved cognitive functions, particularly verbal memory, in visually impaired adolescents. Yoga has eight stages-”Yama, Niyama, Asana, Pranayama, Pratyahara, Dharana, Dhyana, and Samadhi” progressively enhance moral, physical, and mental well-being. Pranayama, involving controlled breathing (inhalation, exhalation, and retention), regulates energy and promotes mental clarity, highlighting yoga’s transformative potential.

Bhastrika Pranayama, mimicking bellows action, influences reaction time (RT). Adolescence, marked by brain reorganization and heightened plasticity, sees significant cognitive and emotional development, especially in executive functions and processing speed. Evidence suggests yoga benefits mental and cognitive health, enhancing memory, attention, and overall function.

Studies on reaction time in school boys showed improvement with yoga, whereas results in females were less conclusive, likely due to gender differences. This study aims to evaluate the effect of Bhastrika Pranayama on attention in adolescents, through a randomized controlled trial, comparing intervention and control groups across genders to establish its impact on cognitive reaction time.

 
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