| CTRI Number |
CTRI/2024/07/071527 [Registered on: 30/07/2024] Trial Registered Prospectively |
| Last Modified On: |
27/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate the effect of yoga in stress among university students |
|
Scientific Title of Study
|
EFFECT OF YOGA BASED INTERVENTION ON STRESS AMONG UNIVERSITY STUDENTS : A RANDOMIZED CONTROL 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 Sai Charan Reddy Bhimavarapu |
| Designation |
Under graduate student |
| Affiliation |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences |
| Address |
Department of Under Graduate Studies Subharti College and Hospital of Naturopathy and Yogic Sciences Swami Vivekanand Subharti University Subhartipuram Meerut UTTAR PRADESH India Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9398562284 |
| Fax |
|
| Email |
charanreddy.bh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR NAIR DHIREN AJIT |
| Designation |
Assistant Professor and Post Graduate (PG) coordinator |
| Affiliation |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences |
| Address |
Department of Post Graduate Studies Subharti College and Hospital
of Naturopathy and Yogic Sciences Swami Vivekanand Subharti
University Subhartipuram Meerut UTTAR PRADESH India Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
7899143619 |
| Fax |
|
| Email |
danny.a.nair@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhay M Shankaregowda |
| Designation |
Principal and Dean |
| Affiliation |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences |
| Address |
Department of Post Graduate Studies Subharti College and Hospital
of Naturopathy and Yogic Sciences Swami Vivekanand Subharti
University Subhartipuram Meerut UTTAR PRADESH India Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9639010531 |
| Fax |
|
| Email |
naturopathy@subharti.org |
|
|
Source of Monetary or Material Support
|
| Maharishi Aurobindo Subharti College and Hospital of Naturopathy
and Yogic Sciences SVSU Meerut UP INDIA
PINCODE: 250005 |
|
|
Primary Sponsor
|
| Name |
Dr Sai Charan Reddy Bhimavarapu |
| Address |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy
and Yogic Sciences Swami Vivekanand Subharti University
Subhartipuram NH-58 Delhi Haridwar Bypass Road Uttar Pradesh
250005 |
| 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 Sai Charan Reddy Bhimavarapu |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences Swami Vivekanand Subharti University Subhartipuram NH-58 Delhi-Haridwar Bypass Road Meerut-250005 UTTAR PRADESH
Meerut
UTTAR PRADESH |
9398562284
charanreddy.bh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| UNIVERSITY ETHICS COMMITTEE (MEDICAL) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
N/A |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
YOGA PROTOCOL WITH BREATHING AWARENESS |
The following protocol will be given with breathing awareness for 45 minutes a day, 5 days per week and for 1 month:
(1)prayer, (2)loosening exercises for 10 minutes,(3)standing asanas- Trikonasana, Triyak tadasana, (4)supine asanas-Setubhanadasana, Pawanamuktasana, (5)prone asanas- Bhujangasana, Marjariasana, (6)sitting asanas-Shashankasana, Ardh matsyendrasana performing for 2 rounds and holding asanas for 30 seconds each. Followed by (7) pranayamas- Nadishodhana, Bhramari, Sheetali, Sheetkari for 3 rounds each and (8) Closing prayer
|
| Comparator Agent |
YOGA PROTOCOL WITHOUT BREATHING AWARENESS |
The following protocol will be given without breathing awareness for 45 minutes a day, 5 days per week and for 1 month: (1)prayer, (2)loosening exercises for 10 minutes,(3)standing asanas- Trikonasana, Triyak tadasana, (4)supine asanas-Setubhanadasana, Pawanamuktasana, (5)prone asanas- Bhujangasana, Marjariasana, (6)sitting asanas-Shashankasana, Ardh matsyendrasana performing for 2 rounds and holding asanas for 30 seconds each. Followed by (7) pranayamas- Nadishodhana, Bhramari, Sheetali, Sheetkari for 3 rounds each and (8) Closing prayer |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Willing to participate in study
Students preparing for their exams |
|
| ExclusionCriteria |
| Details |
Recent surgery
Females under menstruation
Undergoing any medications for a longer period of time |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Perceived Stress Scale (PSS-10) |
Before Intervention and After one month yogic intervention |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 4 |
|
Date of First Enrollment (India)
|
25/08/2024 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
Recent studies have shown an increase in incidence of stress among university students especially during exam times and this study aims at proving the effectiveness of yoga along with breath awareness for students facing exam related stress. |