| CTRI Number |
CTRI/2026/03/105603 [Registered on: 09/03/2026] Trial Registered Prospectively |
| Last Modified On: |
08/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Effects of Cooling pranayama on brain activity and State Relaxation |
|
Scientific Title of Study
|
Effects of Cooling pranayama on middle latency auditory evoked potential and State Relaxation |
| 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 Shirley Telles |
| Designation |
Consultant |
| Affiliation |
Patanjali Research Foundation (trust) |
| Address |
Department of Yoga Research, 2nd floor, Sadbhawana Building, Patanjali Research Foundation (Trust), Patanjali Yogpeeth Phase 1
Hardwar
UTTARANCHAL
249405
India |
| Phone |
09897963254 |
| Fax |
|
| Email |
office@prft.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shirley Telles |
| Designation |
Consultant |
| Affiliation |
Patanjali Research Foundation (trust) |
| Address |
Department of Yoga Research, 2nd floor, Sadbhawana Building, Patanjali Research Foundation (Trust), Patanjali Yogpeeth Phase 1
Hardwar
UTTARANCHAL
249405
India |
| Phone |
09897963254 |
| Fax |
|
| Email |
office@prft.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shirley Telles |
| Designation |
Consultant |
| Affiliation |
Patanjali Research Foundation (trust) |
| Address |
Department of Yoga Research, 2nd floor, Sadbhawana Building, Patanjali Research Foundation (Trust), Patanjali Yogpeeth Phase 1
Hardwar
UTTARANCHAL
249405
India |
| Phone |
09897963254 |
| Fax |
|
| Email |
office@prft.co.in |
|
|
Source of Monetary or Material Support
|
| Patanjali Research Foundation (Trust)
Department of Yoga Research, 2nd floor, Sadbhawana Building, Patanjali Research Foundation (Trust), Patanjali Yogpeeth Phase 1 |
|
|
Primary Sponsor
|
| Name |
Patanjali Research Foundation trust |
| Address |
Department of Yoga Research, 2nd floor, Sadbhawana Building, Patanjali Research Foundation (Trust), Patanjali Yogpeeth Phase 1 |
| Type of Sponsor |
Research institution |
|
|
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 Shirley Telles |
Patanjali Research Foundation (Trust) |
Department of Yoga Research, 2nd floor, Sadbhawana Building, Patanjali Research Foundation (Trust), Patanjali Yogpeeth Phase 1
Hardwar
UTTARANCHAL |
09897963254
office@prft.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Patanjali Research Foundation Trust |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Based on semi structure Interview |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Active Control |
Breath Awareness (BAW) The total duration of the sessions will be 25 minutes below Time point: (i)Pre (5 min), (ii) During (15 minutes) intervention/control (iii) Post (5 minutes) Assessments include Mid latency auditory evoked potential, Visual Analog Scale (VAS) to assess the quality of the practice session, and the state relaxation Questionnaire. |
| Comparator Agent |
Control group |
Quiet seated Rest (QR) The total duration of the sessions will be 25 minutes, below Time point: (i)Pre (5 min), (ii) During (15 minutes) intervention/control (iii) Post (5 minutes) Assessments include Mid latency auditory evoked potential, Visual Analog Scale (VAS) to assess the quality of the practice session, and the relaxation state Questionnaire. |
| Intervention |
Yoga intervention group |
Sheetali Pranayama
The total duration of the sessions will be 25 minutes, as detailed below Time pre (5 min), (ii) During (15 min) intervention/control session, and (iii) Post (5 min) Assessments include Mid latency auditory evoked potential (MLAEP), Visual Analoge (VAS) to assess the quality of the practice session, and the relaxation state |
| Intervention |
Yoga Intervention group |
Sheetkari Pranayama
The total duration of the sessions will be 25 minutes, as detailed below Time pre (5 min), (ii) During (15 min) intervention/control session, and (iii) Post (5 min) Assessments include Mid latency auditory evoked potential (MLAEP), Visual Analoge (VAS) to assess the quality of the practice session, and the relaxation state |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Participants with (i) normal health based on a semi structured interview, and (ii) Students having at least 3 months of experience in breathing techniques (pranayama) |
|
| ExclusionCriteria |
| Details |
Those who will be taking medication and having history of smoking, consuming tobacco, alcohol, mental health disorders, extra systole, hypertension, respiratory conditions, disorders of hearing (based on self report and auditory threshold check) and cardiac conditions will be excluded from the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Middle latency auditory evoked potential |
The total duration of the intervention 28 minutes i.e., (i) Pre (5 Minutes), (ii) During 18 minutes with three epoches of 5 minutes one minute rest between two consecutive epoches) and iii) Post (5 minutes). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relaxation State Questionnaire (RSQ), and (b) Visual analogue scale (VAS) |
(i) Relaxation State Questionnaire (RSQ) (Pre and post)
ii) Visual analogue scale (VAS) (Post) |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
03/04/2026 |
| 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="0"
Months="6"
Days="0" |
|
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 - NO
|
|
Brief Summary
|
The objective of the present study is to determine the effect of cooling pranayama on cortical activity of the brain in healthy volunteers |