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CTRI Number  CTRI/2025/01/079556 [Registered on: 27/01/2025] Trial Registered Prospectively
Last Modified On: 22/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of yoga on cardiac response to stress and cognitive Function in People with elevated anxiety 
Scientific Title of Study   Effect of Yoga on Cardiac autonomic stress reactivity and cognitive functions among individuals with elevated anxiety: A randomized controlled 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  Kashinath G Metri 
Designation  Assistant Professor  
Affiliation  Central University of Rajasthan 
Address  Department of yoga, Central University of Rajasthan, NH-8, Bandar Sindri

Ajmer
RAJASTHAN
305817
India 
Phone  9035257626  
Fax    
Email  kashinath@curaj.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Kashinath G Metri 
Designation  Assistant Professor  
Affiliation  Central University of Rajasthan 
Address  Department of yoga, Central University of Rajasthan, NH-8, Bandar Sindri

Ajmer
RAJASTHAN
305817
India 
Phone  9035257626  
Fax    
Email  kashinath@curaj.ac.in  
 
Details of Contact Person
Public Query  
Name  Kashinath G Metri 
Designation  Assistant Professor  
Affiliation  Central University of Rajasthan 
Address  Department of yoga, Central University of Rajasthan, NH-8, Bandar Sindri

Ajmer
RAJASTHAN
305817
India 
Phone  9035257626  
Fax    
Email  kashinath@curaj.ac.in  
 
Source of Monetary or Material Support  
Central University of Rajasthan, NH 8, Bandarsindari, Ajmer, Rajasthan, India-305817 
 
Primary Sponsor  
Name  Kashinath G Metri  
Address  Department of yoga, Central University of Rajasthan, NH-8, bandarsindari, ajmer, rajasthan-305817 
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 Kashinath G Metri  Central University of Rajasthan   Faculty room no. 1 ( Sri Aurobindo kaksa), Department of Yoga, Central University of Rajasthan, NH-8, Bandar Sindri, ajmer, Rajasthan-305817
Ajmer
RAJASTHAN 		 9035257626

kashinath@curaj.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Human Institutional Ethics Committee, Central University of Rajasthan  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Elevated Anxiety 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Walking intervention   The comparator is the walking intervention. Walking is a form of aerobic exercise that contributes to overall physical well-being. Control group will walk 60 mins, minimum 3 times in a week for 8 weeks.  
Intervention  Yoga therapy   A 60-minute validated yoga module, 3 times in a week for 8 consecutive weeks. Comprising asana, pranayama and meditation.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  (1) Consented university students of age 18-25 years,
(2) score of Hamilton anxiety rating scale more than 18. 
 
ExclusionCriteria 
Details  (1) Cardiopulmonary compensatory conditions
(2) Previous exposure to yoga in the past six months
(3) History of other mental disorders
(4) Other incapacitating disorders that may prevent participants from fully participating in the study
(5) History of substance abuse
(6) History of long-term medication 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary Outcome

Cardiovascular measures
a) Short-term HRV
b) Blood pressure/heart rate
 		 All assessments will be taken at baseline (0 week) and after 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary Outcome
Cognitive measures
a) Selective Attention
b) Working Memory Capacity

 		 All assessments will be taken at baseline (0 week) and after 8 weeks  
Psychological measures
a) State and Trait anxiety
b) Anxiety severity
c) Perceived stress
d) Sleep Quality
 		 All assessments will be taken at baseline (0 week) and after 8 weeks 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "74"
Final Enrollment numbers achieved (India)="74" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/02/2025 
Date of Study Completion (India) 08/05/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   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 - NO
Brief Summary  

This study explores the impact of an 8-week yoga intervention on individuals with elevated anxiety. Anxiety, characterized by heightened stress and hyperarousal, is linked to impaired cardiac autonomic functions and cognitive deficits, negatively affecting overall well-being and academic performance. The randomized controlled trial (RCT) aims to evaluate how yoga influences cardiac autonomic stress reactivity, cognitive functions (working memory and attention), and psychological measures like anxiety, stress, and sleep quality. Participants, aged 18–25, will be randomly assigned to either a yoga intervention group or a control group. The yoga group will engage in structured 60-minute sessions three times a week, focusing on traditional practices to enhance vagal tone and autonomic balance. The control group will participate in walking exercises. Data will be collected using tools like heart rate variability, cognitive assessments, and validated psychological scales. Yoga’s potential to reduce sympathetic overactivity and improve parasympathetic activity aligns with evidence supporting its benefits in reducing stress, enhancing cognitive performance, and improving mental health. If successful, the study could position yoga as a low-cost, community-based intervention for managing anxiety and its associated challenges, contributing to the growing field of mind-body research.

 
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