| CTRI Number |
CTRI/2025/07/090595 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Yoga Therapy for Parkinsons Disease |
|
Scientific Title of Study
|
Efficacy of a Customized Yoga Therapy Module for People Living with Early Parkinsonism - A Randomized Controlled Clinical Trial |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
A Lourdu Mary |
| Designation |
Ph D Scholar |
| Affiliation |
Yenepoya Deemed to be University |
| Address |
Department of Naturopathy YS and Geriatric Medicine
Yenepoya Deemed to be University
Deralakatte
Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7092595289 |
| Fax |
|
| Email |
lour51083@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Prabha Adikari |
| Designation |
Professor, HOD |
| Affiliation |
Yenepoya (Deemed to be University) |
| Address |
Department of Geriatric Medicine,
Yenepoya Medical College Hospital,
Yenepoya (Deemed to be University)
Deralakatte
Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
988091290 |
| Fax |
|
| Email |
prabharaghuveer@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
A Lourdu Mary |
| Designation |
Ph D Scholar |
| Affiliation |
Yenepoya Deemed to be University |
| Address |
Department of Naturopathy YS and Geriatric Medicine
Yenepoya Deemed to be University
Deralakatte
Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7092595289 |
| Fax |
|
| Email |
lour51083@gmail.com |
|
|
Source of Monetary or Material Support
|
| The Monetory and Material support will be provided from the Department of Geriatric Medicine, Yenepoya Medical College Hospital, Deralakatte, Mangalore-575018, Karnataka, INDIA |
|
|
Primary Sponsor
|
| Name |
ALourdu Mary |
| Address |
Department of Naturopathy YS and Geriatric Medicine
Yenepoya (Deemed to be University)
Deralakatte
Mangalore-575018
Karnataka
INDIA |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrPrabha Adhikari |
Sri Sai Niketan Sevashrama |
Daigoli
Kodlamogaru post
Bolna Road
Manjeshwar 671323
Kasaragod
KERALA |
988091290
24676@yenepoya.edu.in |
| DrPrabha Adhikari |
Little sisters of the poor |
Little Sisters Of The Poor
St Anthonys Hill
Maroli Kulshekar Post
Mangalore 575 005
Dakshina Kannada
KARNATAKA |
988091290
24676@yenepoya.edu.in |
| DrPrabha Adhikari |
missionnaries of Charity |
Sister In-Charge
Missionaries of Charity
Vaslane, 1st cross Balmatta
Behind Unity Hospital
Mangalore- 575002
Dakshina Kannada
KARNATAKA |
988091290
24676@yenepoya.edu.in |
| DrPrabha Adhikari |
Olavinahalli |
Olavinahalli Old age home
Thalapady
Mangalore 575022
Dakshina Kannada
KARNATAKA |
988091290
24676@yenepoya.edu.in |
| DrPrabha Adhikari |
Pachim Trust |
PACHIM TRUST
NEHRU NAGAR
ULLAL
Dakshina Kannada
KARNATAKA |
988091290
24676@yenepoya.edu.in |
| DrPrabha Adhikari |
prasanth Niwas |
Sister In-Charge
St. Joseph’s Prashanth Niwas
Jeppu,
Mangalore-575002
Dakshina Kannada
KARNATAKA |
988091290
24676@yenepoya.edu.in |
| DrPrabha Adhikari |
St Anne |
Sister In-Charge
St Anns Home For The Aged
Bendoorwell
Mangalore -575002
Dakshina Kannada
KARNATAKA |
988091290
24676@yenepoya.edu.in |
| DrPrabha Adhikari |
White Doves |
Psychiatric Nursing and Destitute Home,
Maroli,
Kulshekara
Mangalore-575005
Dakshina Kannada
KARNATAKA |
988091290
24676@yenepoya.edu.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| YEC-2 |
Approved |
| Yenepoya Ethics committee 2 |
Approved |
| Yenepoya Ethics committee 2 |
Approved |
| Yenepoya Ethics committee 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G20||Parkinsons disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Customized Yoga therapy Module |
Series of warm-ups, yogic postures, Pranayama, and Meditation. 1 hr of Yoga Therapy for a period of 6 months. |
| Comparator Agent |
MDS-UPDRS, 4. PDQ 39, ACE-III, (SCOPA) SLEEP, GIDS, BBS, TUG |
MDS-UPDRS The Movement Disorder Society-sponsored revision of the Unified Parkinson’s Disease Rating Scale.
PDQ 39-Item Parkinson’s Disease Quality of Life Questionnaire Summary Index
Addenbrooke’s Cognitive Examination-ACE-III
SCales for Outcomes in PArkinson’ disease (SCOPA) SLEEP
Gastro Intestinal Dysfunction Scale for Parkinson’s Disease
Berg Balance Scale
10. Heart Rate Variability 4-minutes Deep breathing ECG
|
|
|
Inclusion Criteria
|
| Age From |
55.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
People with Idiopathic and vascular Parkinsonism aged b/w 55 – 80 are included. Only 1-3 Hoehn &Yahr staging scale of early Parkinsonism who are able to be independent in doing their activities. Able to give written consent and to understand instruction and synchronize the practices, even though aged signs and symptoms are present. |
|
| ExclusionCriteria |
| Details |
People with other secondary Parkinsonism, acute disease and disorders, major surgery within two months, practicing already yoga, severe falling episodes and suffering from mental health disorders will be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome measure would be MDS-UPDRS motor and non-motor functions. The secondary outcome measures will be cognitive scores by Addenbrooks outcome of Quality of life measured by the Parkinsons disease rating scale,Quality of Sleep, postural imbalance, and the gastro intestinal dysfunction on the first month, at the end of 3 months and 6 months. Adverse effects will also be noted in both groups by the PI |
6 months of Yoga therapy intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The practice of yoga disciplines, strengthens, quietens, and relaxes your body and mind.
You gain good balance, flexibility, mobility, and postural stability. Improved sleep and reduced stress and anxiety. Good cognitive function is seen within a few months of practice. Even the control group is taken care of by providing Physiotherapy stretches. |
6months |
|
|
Target Sample Size
|
Total Sample Size="106"
Sample Size from India="106"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/07/2025 |
| 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="3"
Months="6"
Days="20" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Efficacy of a Customized Yoga Therapy Module for People Living With Early Parkinsonism—A Controlled Clinical Trial Today yoga and its therapy are used widely in modern medicine as an adjuvant therapy. Our study, "Efficacy of a Customized Yoga Therapy Module for People Living With Early Parkinsonism—A Controlled Clinical Trial" focuses on improving the health of the geriatric population, especially those who suffer from the early stages of H&YI-III stage Parkinsonism disease. This research project is an interventional study using a cluster sampling method without randomization, conducted as a controlled clinical trial involving 130 participants (65:65) in stages 1-3 of Hoehn and Yahr over a six-month intervention period. Study populations are from the aged homes of Mangalore city and the geriatric trusts aged between 45 and 80. Initially, a medical camp will be conducted to screen the PD population in the aged homes as well as in the trust. The Department of Geriatric Medicine, Yenepoya Medical College Hospital, will carry out this PD screening test. The study will be explained clearly to the participants with detailed information and we get their voluntariness and willingness to participate in the study with the consent form signature. The selected potential persons from the initial to intermediate stages will be divided into study and control groups, 65:65, using the cluster sampling method as per inclusion and exclusion criteria. No randomization is applied. There will not be any change in the intake of medicines, and the adverse effects of the dosage changes and other health complaints will be noted during the study period. One hour of customized yoga therapy practice 5 days a week for 6 months will be gradually given week- and month-wise for the interventional group. Both groups will be given a series of geriatric physiotherapy movements for their everyday practices as a standard of care. There will be three interventions: the initial/first month, the intermediate/third month, and the final/sixth month, and the data will be collected accordingly and analyzed statistically. A p-value <0.05 will be considered statistically significant. Data will be collected using the International Movement Disorder Society questionnaires and other related questionnaires. Since the MDS-UPDRS questionnaires were generated, and permission was received from them, data will be shared. |