| CTRI Number |
CTRI/2026/03/105675 [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 Ujjayi pranayama on brain activity |
|
Scientific Title of Study
|
Effects of Ujjayi 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 |
|
| 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 |
|
| 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 |
|
| 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
|
| (Trust), Patanjali Yogpeeth Phase 1, Bahadrabad, Haridwar, Uttrakhand, India, 249405 |
|
|
Primary Sponsor
|
| Name |
Patanjali Research Foundation trust |
| Address |
Patanjali Research Foundation (Trust), Patanjali Yogpeeth Phase 1, Bahadrabad, Haridwar, Uttrakhand, India, 249405 |
| 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 |
Healthy base on semi structure Interview |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
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 |
| (a) Middle latency auditory evoked potential |
three time points, i.e., (i) Pre (baseline), (ii) During (intervention/control session), and (iii) Post (After the intervention/control session) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| (a) Relaxation State Questionnaire (RSQ), and (b) Visual analogue scale (VAS) |
two time points i.e. (i) Pre (baseline) and (ii) Post (after the intervention/control session) |
|
|
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 Applicable |
| 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 study is to determine e the effects of Ujjayi pranayama on middle latency auditory evoked potential and State Relaxation. |