FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/08/072989 [Registered on: 27/08/2024] Trial Registered Prospectively
Last Modified On: 29/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy
Screening
Behavioral 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effects of yoga in improving social bonding and mental health among village female college students. 
Scientific Title of Study   Exploring the effects of yoga in enhancing social connectedness and psychological wellbeing among rural female college students. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  NATESAMURTHY V 
Designation  Ph.D RESEARCH SCHOLAR 
Affiliation  SRM Institute of Science and Technology 
Address  Room No: 201, Department of Yoga, Faculty of Science and Humanities, SRM Institute of Science and Technology, SRM Nagar, Potheri, Kattankulathur, Chengalpattu.

Kancheepuram
TAMIL NADU
603203
India 
Phone  9884238820  
Fax    
Email  v.natesamurthy@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  NATESAMURTHY V 
Designation  Ph.D RESEARCH SCHOLAR 
Affiliation  SRM Institute of Science and Technology 
Address  Room No:201, Department of Yoga, Faculty of Science and Humanities, SRM Institute of Science and Technology, SRM Nagar, Potheri, Kattankulathur, Chengalpattu.

Kancheepuram
TAMIL NADU
603203
India 
Phone  9884238820  
Fax    
Email  v.natesamurthy@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr R MOHANAKRISHNAN 
Designation  Director - Sports 
Affiliation  SRM Institute of Science and Technology 
Address  Department of Physical Education and Sports Sciences, Faculty of Science and Humanities, SRM Institute of Science and Technology, SRM Nagar, Potheri, Kattankulathur, Chengalpattu.

Kancheepuram
TAMIL NADU
603203
India 
Phone  9566033337  
Fax    
Email  mohanakrishnansrm@gmail.com  
 
Source of Monetary or Material Support  
Department of yoga, Faculty of Science and Humanities, SRM Institute of Science and Technology, SRM Nagar, Potheri, Kattankulathur, Chengalpattu Dt, Tamil Nadu - 603203. 
 
Primary Sponsor  
Name  NATESAMURTHY V 
Address  Department of Yoga, Faculty of Science and Humanities, SRM Institute of Science and Technology, SRM Nagar, Potheri, Kattankulathur, Chengalpattu Dt, Tamil Nadu - 603203. 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr RAJARAJAN K  SRM Institute of Science and Technology  Department of Yoga, Faculty of Science and Humanities, SRM Institute of Science and Technology, SRM Nagar, Potheri, Kattankulathur, Chengalpattu, Tamil Nadu - 603203
Kancheepuram
TAMIL NADU 		 9677844318

rajankrish95@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRM Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Rural Female College Students. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Active control Group  They will not receive any yogic practices and follow their regular activities.  
Intervention  Yogic Practices  Yogic practices will be given to intervention group for 5 days per week for 12 weeks . 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  23.00 Year(s)
Gender  Female 
Details  1. Rural female college students aged between 18-23 only will be included.
2. Volunteers without any ailments and medication only will be included.
 
 
ExclusionCriteria 
Details  1. Other age group students, students from city background and other gender volunteers will be excluded in this study.
2. Volunteers having any ailments and medication will be excluded.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Significant improvement in social connectedness and psychological well-being.  12 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="82"
Sample Size from India="82" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/09/2024 
Date of Study Completion (India) 31/05/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="10" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  if the journal of publication requires data will be made available through their requested format.

  6. For how long will this data be available start date provided 26-12-2024 and end date provided 26-12-2026?
    Response (Others) -  immediately following publication and ending 2 years following publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The hypothesis is set to be there would be any significant differences due to twelve weeks of yoga intervention among rural female college students on social connectedness and psychological well-being. Yogic practices will be given for 5 days per week for 12 weeks for experimental Group and control group will not receive any practices and they will lead their routine life. Pre and Post data will be collected using The Tromso Social Intelligence Scale for social connectedness and WHO – 5 well-being Index for psychological well-being. All the data will be analyzed using statistical techniques and results will be documented and published in any reputed journal. 
Close