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CTRI Number  CTRI/2025/01/079735 [Registered on: 29/01/2025] Trial Registered Prospectively
Last Modified On: 25/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [yoga in undergraduate students ,karnataka, india]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of 12weeks of yoga on KAP and stress marker in Undergraduate students  
Scientific Title of Study   Exploring Knowledge Attitude and Practice regarding yoga and its effect on serum cortisol and oxidative stress marker among undergraduate students effect on serum cortisol and oxidative stress indices among undergraduate 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  Mamatha G 
Designation  PhD Research scholar / assistant professor 
Affiliation  Rajiv gandhi university of health sciences, Bangalore.jayanagar 3rd block. 
Address  Research scholar department of biochemistry Srinivas institute of allied health sciences, Mukka , manglore.(Phd)
assistant professor department of biochemistry 1st floor room No 2 nanjappa institute of allied health sciences , gadikoppa , sagar road , shivamogga
Shimoga
KARNATAKA
577451
India 
Phone  09916480453  
Fax    
Email  mamathaganga8@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shreelaxmi V Hegde 
Designation  Professor 
Affiliation  Rajiv Gandhi University of Health Sciences  
Address  Department of Biochemistry Srinivas Institute of Medical Sciences, Mukka Manglore.
Department Biochemistry 3rd floor Srinivas Institute of Medical Sciences Srinivas Nagar ,Mukka , Manglore-574146 ,Karnataka, India
Dakshina Kannada
KARNATAKA
574146
India 
Phone  9986668611  
Fax    
Email  shreelaxmi.hegde@gmail.com  
 
Details of Contact Person
Public Query  
Name  Mamatha G 
Designation  PhD Research Scholar / Assistant Professor 
Affiliation  Rajiv Gandhi University of Health Seiences  
Address  Biochemistry 2nd division ,Nanjappa Life Care Nanjappa Institute of Allied Health Sciences , Shivamoga- 577201, Karnataka , India.
PhD Research Scholar Department of Biochemistry Srinivas Nagar Mukka, Manglore-574146
Dakshina Kannada
KARNATAKA
577451
India 
Phone  09916480453  
Fax    
Email  mamathaganga8@gmail.com  
 
Source of Monetary or Material Support  
Nanjappa Institute of Allied Health Sciences, Nanjappa life care , Gandikoppa , Sagar Road , Shimoga - 577201, karnataka, India 
 
Primary Sponsor  
Name  nil 
Address  nil 
Type of Sponsor  Other [] 
 
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 Mamatha G  Nanjappas Intitute of Allied Health Sciences  Dapartment of Biochemistry, 1st floor , Nanjappa Life Care, Gadikoppa , Shivamoga-577201
Shimoga
KARNATAKA 		 09916480453

mamathaganga8@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Nanjappas Intitutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  healthy human , normal condition undergraduate college based students  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Questionnaire based intervention pre and post yoga  Pre and Post Yoga Questionnaire, 1 hour ( 35 MINUTE ASANA, 15 MINUTE DYANA, 10 MIN PRANAYAMA) 1 HOUR PER DAY 5 DAYS PER WEEK total 12 weeks of yoga intervention  
Comparator Agent  Standard care Preyoga Students- 88 Post Yoga Students intervention -88 To compare with Non yoga Intervention group   Yoga based Questionaries , Computer generated Simple Randamization To compare with yoga group with intervention and non-yoga without intervention group  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  20.00 Year(s)
Gender  Both 
Details  Willing to Participate and to continue Yoga Practice
Aged between 18 to 20
 
 
ExclusionCriteria 
Details  Unwilling to take part in the study
Has been practicing yoga for the previous year
Significant medical history
including congenital heart disease
stroke
seizures
vertigo
caronary artery disease
and status asthmaticus
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Compartion of pre and post yoga intervention in Knowledge , attitude , practice of yoga and see the effect of serum cortisol and oxidative stress indices in undergraduate students
 		 pre intervention is base line
post intervention is after 12 weeks of intervention  
 
Secondary Outcome  
Outcome  TimePoints 
to improve academic performance,  to reduced stress and make healthy lifestyle 
 
Target Sample Size   Total Sample Size="178"
Sample Size from India="178" 
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)   01/05/2025 
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="0"
Months="3"
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 - 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
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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 - Proposals should be directed to [mamathaganga8@gmail.com].

  6. For how long will this data be available start date provided 17-01-2025 and end date provided 17-01-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  
•This study is novel in its approach to evaluating yoga impact on physiological stress markers,Includng serum cortisol and oxidative stress indices, Among health care students.
•Also, the outcomes of this study have significant implications for society , By demonstating the effectiveness of yoga in managing stress and improving mental health , the research supprorts the intergration of yoga program into educational settings, promoting a healthier lifestyle for students.
•This can lead to reduced stress- related health issues, improved academic performance , and overall better quality of life for students.
•Furthermore, the study can inform policymakers and educators about the benefits of yoga, potentially leading to its broader adoption in various educational institutions .
 
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