| CTRI Number |
CTRI/2025/01/079426 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To find out the effect of Agnisar Kriya on changes in heart rate variability and blood pressure in healthy individuals
|
|
Scientific Title of Study
|
The effect of Agnisar Kriya on Autonomic Functions among Healthy volunteers an open labelled randomized controlled trial
|
| 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 R Poornima |
| Designation |
Postgraduate scholar (Department of yoga) |
| Affiliation |
Government yoga and naturopathy medical college and hospital, chennai -6000106 |
| Address |
Department of yoga,second floor,Postgraduate block,Government yoga and naturopathy medical college and hospital, chennai-106
Chennai
TAMIL NADU
6000106
India |
| Phone |
7550180323 |
| Fax |
|
| Email |
poornimanandhu.r@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr AMooventhan |
| Designation |
Assistant medical officer cum lecturer, department of research |
| Affiliation |
Government yoga and naturopathy medical college and hospital, chennai-106 |
| Address |
Department of research, Postgraduate block, second floor, Government yoga and naturopathy medical college and hospital, chennai-106
Chennai
TAMIL NADU
6000106
India |
| Phone |
9844457496 |
| Fax |
|
| Email |
dr.mooventhan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R Poornima |
| Designation |
Postgraduate scholar (Department of yoga) |
| Affiliation |
Government yoga and naturopathy medical college and hospital, chennai-106 |
| Address |
Department of yoga,second floor,Postgraduate block,Government yoga and naturopathy medical college and hospital, chennai-106
Chennai
TAMIL NADU
6000106
India |
| Phone |
7550180323 |
| Fax |
|
| Email |
poornimanandhu.r@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government yoga and naturopathy medical college and hospital, arumbakkam, chennai-6000106 |
|
|
Primary Sponsor
|
| Name |
Government yoga and naturopathy medical college and hospital |
| Address |
Government yoga and naturopathy medical college and hospital, chennai-6000106 |
| Type of Sponsor |
Government medical college |
|
|
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 R Poornima |
Government yoga and naturopathy medical college and hospital |
2nd floor,Department of Yoga,Post graduate block, Government yoga and naturopathy medical college and hospital,arumbakkam, chennai-106
Chennai
TAMIL NADU |
7550180323
poornimanandhu.r@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government yoga and naturopathy medical college and hospital, Chennai Instituitional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy volunteers aged between 18-35 years |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Agnisar kriya |
Agnisar kriya is a yoga technique for cleansing. To do it, stand with your feet shoulder-width apart, lean forward, and place your palms on your knees. Keep your arms straight, bend your knees slightly, and look at your abdomen. Open your mouth and stick out your tongue. Then, breathe in and out while contracting and expanding your abdomen for 50 breaths, which counts as one round. After each round, rest for 10 seconds with normal breathing. Repeat this for 3 rounds each day, for 5 days a week, over 2 weeks. |
| Comparator Agent |
Breathing awareness |
The participants will be instructed to sit in sukhasana (easy pose) with hands on their knees with eyes closed. The participant will be instructed to concentrate on breathing for 3 minutes,
once a day for 5 days in a week for 2 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1.Healthy adults willing to participate in the study by signing the consent form
2.There should not be any co-morbidities
|
|
| ExclusionCriteria |
| Details |
1.Female participants who are pregnant
2.Under any medication/treatment/ supplement
3.Female participants during menstruation will not be recruited
4.Participants involved in another research study.
5.Participants with auditory and visual deficits.
6.Participants with any congenital anomaly |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Heart Rate Variability (HRV) |
Heart Rate Variability (HRV) will be taken at baseline and 2 weeks after the intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Blood Pressure(BP)and Pulse Rate(PR) |
Blood Pressure(BP)and Pulse Rate(PR) will be taken at baseline and2 weeks after the intervention |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
03/04/2025 |
| 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="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
|
A randomized controlled study design will be adopted for this study. 70 participants will be recruited from Government Yoga and Naturopathy medical college and hospital, Chennai. Participants will be randomly allocated into study group (Agnisar kriya) or Control group (Breathing awareness) using computerized randomization technique, allocation concealment will be done using SNOSE (Sequentially Numbered Opaque Sealed
Envelope) technique. The study group will undergo
Agnisar kriya practice 3 rounds for 3 minutes, once a day, 5 days a week for 2 weeks. The control
group will undergo breath awareness for 3 minutes, once a day, 5 days a week for 2 weeks.
Assessment of HRV, blood pressure and pulse rate will be taken before and 2 weeks after the intervention
for both groups |