| CTRI Number |
CTRI/2025/11/097078 [Registered on: 07/11/2025] Trial Registered Prospectively |
| Last Modified On: |
22/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Effect of Ujjayi Pranayama on heart rate variability and mood in healthy adults |
|
Scientific Title of Study
|
Effects of Ujjayi pranayama on psychophysiological variables |
| 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 |
Director of Research |
| Affiliation |
Patanjali Research Foundation Trust |
| Address |
Department of Yoga Research
2nd Floor Sadbhawana Building
Patanjali Research Foundation Trust (PRFT)
Patanjali Yogpeeth Phase I
Bahadrabad Haridwar 249405
Uttarakhand India
PATANJALI YOGPEETH PHASE I
Hardwar
UTTARANCHAL
249405
India |
| Phone |
09897963254 |
| Fax |
|
| Email |
office@prft.co.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 (PRFT)
Patanjali Yogpeeth Phase I
Bahadrabad Haridwar 249405
Uttarakhand India
PATANJALI YOGPEETH PHASE I
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9760018118 |
| Fax |
|
| Email |
office@prft.co.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 (PRFT)
Patanjali Yogpeeth Phase I
Bahadrabad Haridwar 249405
Uttarakhand India
PATANJALI YOGPEETH PHASE I
UTTARANCHAL
249405
India |
| Phone |
09897963254 |
| Fax |
|
| Email |
office@prft.co.in |
|
|
Source of Monetary or Material Support
|
| Department of Yoga Research
2nd Floor Sadbhawana Building
Patanjali Research Foundation Trust (PRFT)
Patanjali Yogpeeth Phase I
Bahadrabad Haridwar 249405
Uttarakhand India |
|
|
Primary Sponsor
|
| Name |
Patanjali Research Foundation Trust |
| Address |
Department of Yoga Research
2nd Floor Sadbhawana Building
Patanjali Research Foundation Trust (PRFT)
Patanjali Yogpeeth Phase I
Bahadrabad Haridwar 249405
Uttarakhand India |
| 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 (PRFT) |
Department of Yoga Research
2nd Floor Sadbhawana Building
Patanjali Research Foundation Trust (PRFT)
Patanjali Yogpeeth Phase I
Bahadrabad Haridwar 249405
Uttarakhand India
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 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
absolute control group |
Quiet rest (QR)
The total duration of the session will be of 38 minutes as detailed below Time points (i) pre (10 min) includes HRV, respiration, GSC, FPA, and BP will be recorded simultaneously pre (5 min) (ii) during (18 min) HRV, respiration, GSC, FPA, and BP will be recorded simultaneously (iii) post (10 min) includes HRV, respiration, GSC, FPA, and BP will be recorded simultaneously post(5 min)
|
| Comparator Agent |
Active control |
Breath Awareness (BAW)
The total duration of the session will be of 38 minutes as detailed below Time points (i) pre (10 min) includes HRV, respiration, GSC, FPA, and BP will be recorded simultaneously pre (5 min) (ii) during (18 min) HRV, respiration, GSC, FPA, and BP will be recorded simultaneously (iii) post (10 min) includes HRV, respiration, GSC, FPA, and BP will be recorded simultaneously post(5 min) |
| Intervention |
The intervention includes volitional yoga breathing techniques |
Ujjayi Pranayama
The total duration of the session will be of 38 minutes as detailed below Time points (i) pre (10 min) includes HRV, respiration, GSC, FPA, and BP will be recorded simultaneously pre (5 min) (ii) during (18 min) HRV, respiration, GSC, FPA, and BP will be recorded simultaneously (iii) post (10 min) includes HRV, respiration, GSC, FPA, and BP will be recorded simultaneously post(5 min)
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
(i) Students having at least 3 months of experience in breathing techniques (pranayama) (ii) have normal health based on a semi structured interview |
|
| ExclusionCriteria |
| Details |
Those who will be taking medication and having history of smoking, consuming tobacco, alcohol, mental health disorders, extra systole, hypertension 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 |
Physiological Outcomes
(i) Heart Rate Variability to assess parasympathetic activity
(ii) Respiration used to assess breathing Characteristics
(iii) Blood Pressure
(iv) Galvanic Skin Conductance and Finger Plethysmograph uses to asses sympathetic activity |
Time points: Three
The total duration of each session will be 38 minutes with three states i.e.,
(i) pre (10 min),
(ii) during (18 min)
(iii) post (10 min) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Psychological outcomes
(i)Six letter cancellation test (SLCT): The six-letter cancellation test (SLCT) will be use to assess the performance test.
(ii)Global Vigor and Affect (GVA) instrument: The global vigor and affect scale (GVAS) will be used to assess subjective feelings of global vigor and global affect.
|
Time points: Two
(i) Pre: After 5 minutes of pre recording
(ii) Post: After 18 minutes of the intervention |
|
|
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)
|
12/11/2025 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 the effect of ujjayi pranayama on heart rate variability, measure of affect and cognitive performances in healthy adults. |