| CTRI Number |
CTRI/2022/02/040596 [Registered on: 24/02/2022] Trial Registered Prospectively |
| Last Modified On: |
22/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A COMPARITIVE STUDY ON EFFECT OF YOGA AMONG COLLEGE GOING STUDENTS ON PSYCHOPHYSIOLOGICAL CHANGES. |
|
Scientific Title of Study
|
A COMPARATIVE EVALUATION OF YOGIC INTERVENTION ON
PSYCHOPHYSIOLOGICAL CHANGES AMONG COLLEGE
STUDENTS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pooja H R |
| Designation |
Post graduate |
| Affiliation |
SDM College of Naturopathy and Yogic Sciences |
| Address |
Department of yoga, SDM College of naturopathy and yogic sciences, uijre
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9535055064 |
| Fax |
|
| Email |
poojahmurthy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nandeesh |
| Designation |
Asst. Professor , Department of yoga |
| Affiliation |
SDM College of Naturopathy and Yogic Sciences |
| Address |
SDM College of naturopathy and yogic sciences, uijre
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9743605658 |
| Fax |
|
| Email |
nsnandeesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pooja H R |
| Designation |
Post graduate |
| Affiliation |
SDM College of Naturopathy and Yogic Sciences |
| Address |
department of yoga SDM College of naturopathy and yogic sciences, uijre
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9535055064 |
| Fax |
|
| Email |
poojahmurthy@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM College of naturopathy and yogic sciences |
|
|
Primary Sponsor
|
| Name |
Dr Pooja HR |
| Address |
SDM College of naturopathy and yogice sciences uijre |
| 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 |
| Dr Pooja H R |
SDM College of naturopathy and yogic sciences |
department of yoga, SDM college of naturopathy and yogic sciences , ujire
Dakshina Kannada
KARNATAKA |
9535055064
poojahmurthy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDM college of naturopathy and yogic sciences ujire |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
quality of life |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
no intervention |
control group will not be given any practice. |
| Intervention |
yoga practice |
intervention group will be given a set of yogic practices to be practiced daily for 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Subjects who are willing to participate in this study |
|
| ExclusionCriteria |
| Details |
Not associated with any illness or pathologic entity |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Heart rate variability
The Perceived Stress Scale |
baseline
after 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life |
baseline
after 3 months |
|
|
Target Sample Size
|
Total Sample Size="194"
Sample Size from India="194"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/03/2022 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
] Although many researches have been
conducted to know the influence of yoga in establishing physical and mental
health among students, a very few states the relation between the practice of
yoga in ailment of stress and a very few studies have been noted which
determines the perception of students and their physiological changes after the
practice of yoga and yet few which compare the effect of yoga in students who
practice it on regular basis and who does not. The main aim of this study is to
compare the stress levels and physiological response among students who
practice yoga and students who do not practice yoga. |