| CTRI Number |
CTRI/2022/09/045627 [Registered on: 19/09/2022] Trial Registered Prospectively |
| Last Modified On: |
28/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Bhastrika Pranayama On Healthy Individuals |
|
Scientific Title of Study
|
“Physiological Effect Of Bhastrika Pranayama On Cardio-Pulmonary Variables Among Healthy Individuals- A Randomized Controlled Trail†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Oinam Babbychand Bash Devi |
| Designation |
MD Scholar |
| Affiliation |
Alvas college of naturopathy and yogic sciences |
| Address |
Yoga department,Room no- 07 Alvas college of naturopathy and yogic sciences, mijar, moodbidri
Dakshina Kannada
KARNATAKA
574225
India |
| Phone |
7090392841 |
| Fax |
|
| Email |
babbychandoinam33@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Archana K |
| Designation |
Associate Professor, Guide |
| Affiliation |
Alvas college of naturopathy and yogic sciences |
| Address |
Yoga department,Room no- 07 Alvas college of naturopathy and yogic sciences, mijar, moodbidri
Dakshina Kannada
KARNATAKA
574225
India |
| Phone |
9448152915 |
| Fax |
|
| Email |
dr.archanabnys@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anupritha Ashok |
| Designation |
Assistant Professor, Co-Guide |
| Affiliation |
Alvas college of naturopathy and yogic sciences |
| Address |
Yoga department,Room no- 07 Alvas college of naturopathy and yogic sciences, mijar, moodbidri
Dakshina Kannada
KARNATAKA
574225
India |
| Phone |
7019294074 |
| Fax |
|
| Email |
anuprithaashok@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas College Of Naturopathy And Yogic Sciences, Mijar, Moodbidri, Dakshina Kannada. |
|
|
Primary Sponsor
|
| Name |
Dr Oinam Babbychand Bash Devi |
| Address |
Alvas College Of Naturopathy And Yogic Sciences, Mijar, Moodbidri, Dakshina Kannada. |
| Type of Sponsor |
Other [Self sponser] |
|
|
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 Oinam Babbychand Bash Devi |
Alvas college of Naturopathy and Yogic sciences |
Room no- 07, Yoga Department, Alvas college of naturopathy and yogic sciences, mijar, moodbidri
Dakshina Kannada
KARNATAKA |
7090392841
babbychandoinam33@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee For Human Studies Of Alvas College Of Naturopathy And Yogic Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Cardio-Pulmonary changes |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bhastrika pranayama |
Bhastrika pranayama 5 rounds of 10 strokes per minute for 10 minutes for 5 days in a week for 4 weeks. |
| Comparator Agent |
No intervention |
Normal daily activities followed up for 4 weeks, No intervention or advice is given |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
• Age group-18-25 year
• Gender-Both male and female
|
|
| ExclusionCriteria |
| Details |
• Weak individual
• Systemic illness
• Tobacco chewing
• During the menstrual cycle
• Those who are under medication
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Pulse Oximetry.
2. Blood Pressure
3. Respiratory Rate
4. Peak expiratory flow rate |
Assessments done at two time points:
Pre- assessment- Day 0- Before intervention
Post- assessment- Day 30- After intervention of 4 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
Final Enrollment numbers achieved (Total)= "110"
Final Enrollment numbers achieved (India)="110" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/11/2022 |
| Date of Study Completion (India) |
25/04/2023 |
| Date of First Enrollment (Global) |
01/11/2022 |
| Date of Study Completion (Global) |
25/04/2023 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
- Yoga is the science of right living and such, is intended to be incorporated in daily life. It works on all aspects of the person; the physical, vital, mental, emotional, psychic and spiritual. - The word yoga means “unity†or “oneness†and is derived from Sanskrit word “yuj†which means to join. - Bhastrika is the name of pranayama which imitate the action of the bhastra or “bellow†and regulates the internal fire, heating the physical as well as subtler body. - In bhastrika pranayama inhalation and exhalation are equal and the result of systemic and lung movements are also equal. The breath has to be sucked in and pushed out with little force. - This present study is aimed to evaluate the cardio- pulmonary variables after the practicing of bhastrika pranayama for its further clinical application. |