| 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
|
|
|
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
|
|
|
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.
|