| CTRI Number |
CTRI/2025/08/092358 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
04/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Effect of Bhramari and Sheetali Breathing Exercises Combined with Relaxation Technique on Heart and Lung Health in Healthy Adults |
|
Scientific Title of Study
|
Comparison between the effect of brahmari and sheetali pranayama combined with bensons relaxation technique on cardiorespiratory parameters in healthy adults |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
YASHIKA |
| Designation |
PG STUDENT |
| Affiliation |
Pandit Bhagwat Dayal Sharma University of Health Sciences, Rohtak |
| Address |
College of Physiotherapy
PGIMS , Rohtak
E Block College of Physiotherapy
PGIMS Rohtak Haryana
Rohtak
HARYANA
124001
India |
| Phone |
8059554793 |
| Fax |
|
| Email |
srivastavayashika498@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gitanjali Sikka |
| Designation |
Associate Professor |
| Affiliation |
Pandit Bhagwat Dayal Sharma University of Health Sciences, Rohtak |
| Address |
College of Physiotherapy
PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
7027192620 |
| Fax |
|
| Email |
gsikka27@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
YASHIKA |
| Designation |
PG Student |
| Affiliation |
Pandit Bhagwat Dayal Sharma University of Health Sciences, Rohtak |
| Address |
E Block
College of Physiotherapy
PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8059554793 |
| Fax |
|
| Email |
srivastavayashika498@gmail.com |
|
|
Source of Monetary or Material Support
|
| College of Physiotherapy PGIMS Rohtak |
|
|
Primary Sponsor
|
| Name |
Yashika |
| Address |
College of Physiotherapy PGIMS Rohtak |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Yashika |
Pt. BD Sharma PGIMS |
E- Block
Rohtak
HARYANA |
8059554793
srivastavayashika498@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
no pre existing conditions |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Healthy adults
Individuals with normal baseline cardio-respiratory parameters(BP,HR,RR,SPO2)
Willing participants for study
Non-smokers and non-alcoholics
No prior experience of yoga and pranayama |
|
| ExclusionCriteria |
| Details |
Individual with pre-existing cardiovascular, neurological, psychiatric or respiratory disorders
Experience of yoga and pranayama
Pregnant or lactating woman
Individual with uncontrolled diabetes or thyroid disorders
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Heart rate
2.SPO2
3.Delta pulse rate
4.%heart rate
5.Systolic Blood Pressure
6.Diastolic Blood Pressure
7.Delta SBP
8.Delta DBP
9.Mean arterial Blood pressure
10.Rate pressure product
11.Rate of perceived exertion |
1. Pre,post0,15,30,45,60 min
2. Pre,post0,15,30,45,60 min
3.Post
4.Pre , Post
5. Pre,post0,15,30,45,60 min
6. Pre,post0,15,30,45,60 min
7. post
8. post
9. Pre, Post 15,30 mins
10. Pre, Post
11. Pre, Post |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="350"
Sample Size from India="350"
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)
|
18/08/2025 |
| 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="6"
Days="10" |
|
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
|
Lifestyle of people nowadays has made recent developing craze of pranayama techniques. Relaxation techniques also have made life easy. individual benefits of both these have been already studied . In my study we will be studying combined effects of pranayama and relaxation techniques to know their effects on cardiorespiratory parameters in healthy adults |