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CTRI Number  CTRI/2025/11/096936 [Registered on: 06/11/2025] Trial Registered Prospectively
Last Modified On: 04/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   impact of yoga on cognitive and functional abilities in endosulphan victims 
Scientific Title of Study   Impact of integrative yoga based neurorehabilitation program on cognitive and functional abilities in endosulfan victims: a non randomized cluster 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  Dr Gannyashree 
Designation  PG scholar 
Affiliation  SDM College of Naturopathy and Yogic Sciences  
Address  Department of yoga first floor room no 2 SDM College of Naturopathy and Yogic Sciences Ujire Dakshina Kannada Karnataka

Dakshina Kannada
KARNATAKA
574240
India 
Phone  9972514575  
Fax    
Email  dracharyagannya@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bindu Shridhar 
Designation  Professor and Dean 
Affiliation  SDM College of Naturopathy and Yogic Sciences  
Address  SDM College of Naturopathy and Yogic Sciences Ujire Dakshina Kannada Karnataka

Dakshina Kannada
KARNATAKA
574240
India 
Phone  8277614169  
Fax    
Email  bindu.shridhar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Gannyashree 
Designation  PG scholar 
Affiliation  SDM College of Naturopathy and Yogic Sciences  
Address  Department of yoga first floor room no 2 SDM College of Naturopathy and Yogic Sciences Ujire Dakshina Kannada Karnataka

Dakshina Kannada
KARNATAKA
574240
India 
Phone  9972514575  
Fax    
Email  dracharyagannya@gmail.com  
 
Source of Monetary or Material Support  
Endosulphan Rehabilitation Centre kokkada dakshina kannada karnataka 574198 
Saanidhya Skill Training Centre for Endosulphan Victims Ujire Dakshina Kannada Karnataka 574240 
SDM College of Naturopathy and Yogic Sciences Ujire Dakshina Kannada Karnataka 574240 
 
Primary Sponsor  
Name  Dr Gannyashree 
Address  SDM College of Naturopathy and Yogic Sciences Ujire Dakshina Kannada Karnataka 574240 
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 Gannyashree  SDM College of Naturopathy and Yogic Sciences  Department of yoga first floor room no 2 SDM College of Naturopathy and Yogic Sciences Ujire Dakshina Kannada Karnataka
Dakshina Kannada
KARNATAKA 
09972514575

dracharyagannya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SDM College of Naturopathy and Yogic Sciences Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: T602||Toxic effect of other insecticides,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  standard care  which comprises physiotherapy, craft sessions aimed at promoting fine motor skills and engagement, along with basic educational support for 5 days a week for 6 months. 
Intervention  yoga module  it is a 45 minutes expert validated integrative yoga module containing loosening exercises asanas pranayama designed specifically for endosulphan victims. The yoga intervention will be delivered by a qualified yoga physician and will consist of 45-minute sessions, five days per week, over a total duration of 6 months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Documented evidence of endosulfan exposure or registered victims from official lists.
Informed consent from parent or guardian for participants lacking capacity and assent from participants as feasible.
Ability to follow yoga protocol
Mild to moderate neurological or psychological symptoms.
 
 
ExclusionCriteria 
Details  Severe disability restricting yoga.
Severe psychiatric illness or hospitalization.
Uncontrolled chronic illnesses like BP, diabetes, asthma, epilepsy, cancer
Active infections like fever, skin conditions, TB, etc.
Individuals with unstable doses or recent changes in medication (less than 4 weeks)
Current participation in other interventional studies.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Nine Hole Pegboard Test (NHPT)
2. Post Graduate Institute of Medical Education and Research, Chandigarh Battery of Brain dysfunction (PGI-BBD) 
at baseline, after 3 months, and at 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
1 Berg Balance Scale (BBS)
2 Aberrant Behavioural Checklist (ABC) 
at baseline, after 3 months, and at 6 months 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
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)   15/12/2025 
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="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 - NO
Brief Summary  

The study titled Impact of Integrative Yoga Based Neurorehabilitation Program on Cognitive and Functional Abilities in Endosulfan Victims A Non Randomized Cluster Controlled Trial aims to evaluate the therapeutic potential of yoga in enhancing cognitive and functional outcomes among individuals affected by endosulfan exposure. Endosulfan, a toxic organochlorine pesticide, has caused long term neurological, cognitive, and behavioral impairments in affected communities of Dakshina Kannada and nearby districts. Although multidisciplinary rehabilitation programs exist, they often focus on physical therapy alone and fail to address the mental and emotional dimensions of recovery. Yoga, with its integrative approach combining postures (asanas), breathing techniques (pranayama), meditation, and relaxation, offers a holistic framework to promote neuroplasticity, stress reduction, and cognitive improvement.

This non randomized cluster controlled trial will recruit 48 participants aged 18 to 50 years from government recognized endosulfan rehabilitation centers in Dakshina Kannada district. Participants will be divided into two groups an intervention group receiving an integrated yoga protocol for 45 minutes a day, five days a week for six months, along with standard care, and a control group receiving standard care alone, including physiotherapy and craft based rehabilitation activities. Assessments will be conducted at baseline, 3 months, and 6 months using validated tools which include Nine Hole Peg Test for motor coordination, PGI Battery of Brain Dysfunction for cognitive performance, Berg Balance Scale for physical balance, and Aberrant Behavior Checklist for behavioral assessment.

It is hypothesized that the integrative yoga based rehabilitation will significantly improve fine motor skills, postural stability, cognitive function, and behavioral regulation compared to standard care alone. The intervention emphasizes holistic healing by reducing oxidative stress, improving autonomic balance, and enhancing neurophysiological function. Ethical approval has been obtained from the Institutional Ethics Committee of SDM College of Naturopathy and Yogic Sciences, Ujire. The findings are expected to support yoga as a cost effective, community based neurorehabilitation strategy for endosulfan victims.

 

 
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