| CTRI Number |
CTRI/2025/12/098488 [Registered on: 04/12/2025] Trial Registered Prospectively |
| Last Modified On: |
03/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Other |
|
Public Title of Study
|
The Effect Yoga on Stress on Healthcare Students of Chengalpattu District |
|
Scientific Title of Study
|
The Effect of Vethathiri Maharishi s Simplified Kundalini Yoga on Oxidative Stress Biomarkers among Healthcare Students of Chengalpattu District |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PARTHEEBAN K |
| Designation |
Professor WCSC World community service centre |
| Affiliation |
WCSC World community service centre |
| Address |
Residence 38 nadu street big natham chingleput kanchipuram district
pin 603002
Institute
Directorate of VISION FOR WISDOM LIBRARY BUILDING
An educational wing of the world community service centre,
Temple of consiousness,Arutperum jothi nagar, ALIYAR,POLLACHI, Tamil Nadu PIN 642101
Directorate of VISION FOR WISDOM LIBRARY BUILDING
An educational wing of the world community service centre,
Temple of consiousness,Arutperum jothi nagar, ALIYAR,POLLACHI, Tamil Nadu PIN 642101
Coimbatore
TAMIL NADU
603002
India |
| Phone |
9444384040 |
| Fax |
|
| Email |
parshree@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PARTHEEBAN K |
| Designation |
Professor WCSC WORLD COMMUNITY SERVICE CENTRE |
| Affiliation |
WCSC World community service centre |
| Address |
Residence 38 nadu street big natham chingleput kanchipuram district
pin 603002
Institute
Directorate of VISION FOR WISDOM LIBRARY BUILDING
An educational wing of the world community service centre,
Temple of consiousness,Arutperum jothi nagar, ALIYAR,POLLACHI, Tamil Nadu PIN 642101
Directorate of VISION FOR WISDOM LIBRARY BUILDING
An educational wing of the world community service centre,
Temple of consiousness,Arutperum jothi nagar, ALIYAR,POLLACHI, Tamil Nadu PIN 642101
Coimbatore
TAMIL NADU
603002
India |
| Phone |
9444384040 |
| Fax |
|
| Email |
parshree@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PARTHEEBAN K |
| Designation |
Professor WCSC |
| Affiliation |
WCSC World community service centre |
| Address |
Residence 38 nadu street big natham chingleput kanchipuram district
pin 603002
Institute
Directorate of VISION FOR WISDOM LIBRARY BUILDING
An educational wing of the world community service centre,
Temple of consiousness,Arutperum jothi nagar, ALIYAR,POLLACHI, Tamil Nadu PIN 642101
Directorate of VISION FOR WISDOM LIBRARY BUILDING
An educational wing of the world community service centre,
Temple of consiousness,Arutperum jothi nagar, ALIYAR,POLLACHI, Tamil Nadu PIN 642101
Coimbatore
TAMIL NADU
603002
India |
| Phone |
9444384040 |
| Fax |
|
| Email |
parshree@gmail.com |
|
|
Source of Monetary or Material Support
|
| KARPAGA VINAYAGA INSTITUTE OF DENTAL SCIENCES RECOGNIZED BY DENTAL COUNCIL OF INDIA AFFILIATED TO THE TAMILNADU DR.MGR MEDICAL UNIVERSITY
GST ROAD, CHINNA KOLAMBAKKAM, MADURANTHAGAM TALUK, CHENGALPATTU DISTRICT, TAMILNADU
PIN 603308 |
|
|
Primary Sponsor
|
| Name |
PARTHEEBAN K |
| Address |
Directorate of VISION FOR WISDOM LIBRARY BUILDING
An educational wing of the world community service centre,
Temple of consiousness,Arutperum jothi nagar, ALIYAR,POLLACHI, Tamil Nadu PIN 642101 |
| Type of Sponsor |
Research institution |
|
|
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 |
| DRGRKARTHIKEYAN |
KARPAGA VINAYAGA INSTITUTE OF DENTAL SCIENCE |
KARPAGA VINAYAGA INSTITUTE OF DENTAL SCIENCES RECOGNIZED BY DENTAL COUNCIL OF INDIA AFFILIATED TO THE TAMILNADU DR.MGR MEDICAL UNIVERSITY GST ROAD, CHINNA KOLAMBAKKAM, MADURANTHAGAM TALUK, CHENGALPATTU DISTRICT, TAMILNADU PIN 603308
Kancheepuram
TAMIL NADU |
9842177149
kidsindia07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC KARPAGA VINAYAGA INSTITUTE OF DENTAL SCIENCE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NORMAL |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
Simplified physical exercises only
30 mins/day, 5 days/week, 24 weeks
|
| Intervention |
Experiment group |
SKY (SIMPLIFIED KUNDALINI YOGA): Physical Exercises + Kayakalpa + Meditation
1 hr/day, 6 days/week, 24 weeks
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Aged 18-25
Healthcare students
No prior SKY (SIMPLIFIED KUNDALINI YOGA) experience
|
|
| ExclusionCriteria |
| Details |
Chronic illness or medication
Irregular participation
Other wellness program enrollment
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Sampling method: This RCT includes a pre- and post-test design with 40 participants (20experimental, 20 control) over 6 months. Randomized allocation will be used within a health sciences institution.
Sample size for a study on the effect of Vethathiri Maharishi Simplified Kundalini Yoga (SKY) on oxidative stress biomarkers among healthcare students in Chengalpattu district, previous yoga studies targeting oxidative stress biomarkers usually inform the process.
|
16 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
12/01/2026 |
| 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="6"
Days="0" |
|
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
|
To evaluate the effect of Vethathiri Maharish SKY Simplified Kundalini Yoga practices on stress biomarkers. To measure the stress bio markers like Interleukins Tumor Necrosis Factor Secretory Immunoglobulin A &C reactive protein.
Measure cytokine changes IL 6 IL 1BETA TNF ALPHA. Assess CRP levels. Measure sIgA levels. Analyze changes in the perceived stress scale PSS Compare outcomes between the SKY SIMPLIFIED KUNDALINI YOGA experimental &control groups.
Study design This study uses a randomized controlled trial RCT to evaluate the Vethathiri Maharishi s SKY SIMPLIFIED KUNDALINI YOGA practices on reducing biological &psychological stress levels by the null hypothesis &the alternate hypothesis.
Study setting Health care students of Karpaga Vinayaga Group of Health Care Institutions, mainly from the Karpagavinayaga Dental College. |