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CTRI Number  CTRI/2026/03/105413 [Registered on: 05/03/2026] Trial Registered Prospectively
Last Modified On: 09/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effects of Yoga and Zumba Exercise on Stress and Well-Being in College Students 
Scientific Title of Study   Comparative Efficacy of an 8-Week Yoga Module versus Zumba on Stress, Emotional Distress, and Well-being among University Students: A RCT 
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 Bhasmila Gudivada 
Designation  Student of Msc Yoga Therapy  
Affiliation  National Institution of Mental Health And Neuro Sciences 
Address  G13 OPD BUILDING, DEPARTMENT OF INTEGRATIVE MEDICINE , NIMHANS , BENGALURU, 560029 BANGLORE KARNATAKA 560029 INDIA

Bangalore
KARNATAKA
560029
India 
Phone  6300493056  
Fax    
Email  bhashmilag@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Lakshmi Nishitha J 
Designation  Scientist C 
Affiliation  National Institution of Mental Health And Neuro Sciences 
Address  G13 OPD BUILDING, DEPARTMENT OF INTEGRATIVE MEDICINE , NIMHANS , BENGALURU, 560029 BANGLORE KARNATAKA 560029 INDIA

Bangalore
KARNATAKA
560029
India 
Phone  8762150803  
Fax    
Email  nishitha.jasti910@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Hemanth Bhargav  
Designation  Associate Professor 
Affiliation  National Institution of Mental Health And Neuro Sciences 
Address  G13 OPD BUILDING, DEPARTMENT OF INTEGRATIVE MEDICINE , NIMHANS , BENGALURU, 560029 BANGLORE KARNATAKA 560029 INDIA

Bangalore
KARNATAKA
560029
India 
Phone  8762019348  
Fax    
Email  drbhargav.nimhans@gmail.com  
 
Source of Monetary or Material Support  
CCRYN Ministry of AYUSH.  
 
Primary Sponsor  
Name  Dr Hemanth Bhargav  
Address  room no 3, 1st Floor, Department of Integrative Medicine, NIMHANS. 
Type of Sponsor  Research institution and hospital 
 
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 Bhasmila Gudivada  Department of Integrative Medicine, National Institute of Mental Health And Neuro sciences  1st floor, room no-3,Department of Integrative Medicine, NIMHANS, Hosur Road/Marigowda Road, Lakkasandra, Bengaluru, Karnataka 560029
Bangalore
KARNATAKA 		 6300493056

bhashmilag@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Human Ethics Committee for Research in AYUSH and Integrative Medicine  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  NA 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Yoga intervention   A validated yoga module designed for stress reduction, incorporating practices like physical postures (asanas), breath regulation (pranayama), and meditation (dhyana). Three sessions per week on alternate days for 8 weeks (24 sessions total) duration of 60 minutes per session. 
Comparator Agent  Zumba intervention   A dance-based aerobic exercise programme, serving as an active control intervention. Three sessions per week on alternate days for 8 weeks (24 sessions total),duration of 60 minutes per session. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  Currently enrolled as a student at NIMHANS,
Aged between 18 to 30 years (both male and female),
Perceived Stress Scale (PSS) score more than 14, indicating moderate-to-high stress levels,
General Health Questionnaire-12(GHQ-12) indicating psychological distress,
Willing to participate and provide written informed consent. 
 
ExclusionCriteria 
Details  Regular yoga practice (more than 1 session per week) for more than 3 months prior to enrolment,
Currently receiving psychological or psychiatric treatment for stress or mental illness,
History of major psychiatric disorder or substance use disorder,
Physical conditions that contraindicate participation in yoga or aerobic exercise,
Known cardiac or renal comorbidities,
Active inflammatory, autoimmune, or infectious disease.
Current use of anti-inflammatory medications, immunosuppressants, or corticosteroids 
 
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 
Perceived Stress Scale (PSS-10)  At baseline(week 0), Mid-Intervention (Week 4) and post(week 8) 
 
Secondary Outcome  
Outcome  TimePoints 
General Health Questionnaire-12 (GHQ-12),WHO-5 Well-being Index, Satisfaction with Life Scale, YAMA Scale, Klesha Scale and BMI  baseline(week 0), Mid-Intervention (Week 4) and post(week 8) 
Heart Rate Variability (HRV) and Nuclear Factor Kappa B   at baseline (week 0) and post (week 8) 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   16/03/2026 
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="1"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

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

  3. Who will be able to view these files?
    Response (Others) -  ONLY ON REQUEST

  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 [bhashmilag@gmail.com].

  6. For how long will this data be available start date provided 30-06-2027 and end date provided 30-06-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

The primary purpose of this protocol is to evaluate and compare the efficacy of an 8week structured yoga module versus Zumba on perceived stress, emotional distress, and overall wellbeing among university students. By utilizing both psychological scales and physiological markers such as Heart Rate Variability (HRV) and Nuclear Factor Kappa B, the study aims to determine the specific therapeutic benefits of mind body interventions compared to general aerobic exercise. The study hypothesizes that participants in the yoga group will demonstrate a significantly greater reduction in stress and inflammatory markers, along with superior improvements in autonomic function and psychological wellbeing, compared to those in the Zumba active control group.

This study provides a scientific framework to integrate Yoga or Zumba into university wellness programs as evidence based, nonpharmacological interventions. By analyzing physiological biomarkers like HRV and Nuclear Factor Kappa B, it offers a deeper understanding of how mind body practices mitigate stress induced inflammation, paving the way for standardized, scalable mental health strategies in academic settings.

 
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