| CTRI Number |
CTRI/2025/03/082096 [Registered on: 10/03/2025] Trial Registered Prospectively |
| Last Modified On: |
07/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Helping stroke patients with simple yoga exercises and ayurvedic procedures |
|
Scientific Title of Study
|
Development, content validation and feasibility testing of an integrative yoga and ayurveda(IYA) therapy for post-stroke rehabilitation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tarana Parida |
| Designation |
Student of M.Sc. Yoga Therapy |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
G-13, OPD Block, Department of Integrative Medicine, NIMHANS Bangalore, KARNATAKA
Bangalore KARNATAKA 560029 India |
| Phone |
8763610076 |
| Fax |
|
| Email |
paridatarana823@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Hemant Bhargav |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
G-13, OPD Block, Department of Integrative Medicine, NIMHANS Bangalore, KARNATAKA
Bangalore KARNATAKA 560029 India |
| Phone |
8762019348 |
| Fax |
|
| Email |
drbhargav.nimhans@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Hemant Bhargav |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
G-13, OPD Block, Department of Integrative Medicine, NIMHANS Bangalore, KARNATAKA
Bangalore KARNATAKA 560029 India |
| Phone |
8762019348 |
| Fax |
|
| Email |
drbhargav.nimhans@gmail.com |
|
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Source of Monetary or Material Support
|
| National Institute of Mental Health and Neurosciences (NIMHANS), Bangalore, KARNATAKA 560029, INDIA |
|
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Primary Sponsor
|
| Name |
Tarana Parida |
| Address |
G-13, OPD Block, Department of Integrative Medicine, NIMHANS Bangalore, KARNATAKA 560029 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Hemant Bhargav |
National Institute of Mental Health and Neurosciences (NIMHANS) |
Assessment Room 1, First Floor, Ayurveda Division, Department of Integrative Medicine Bangalore KARNATAKA |
8762019348
drbhargav.nimhans@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 |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I60-I69||Cerebrovascular diseases. Ayurveda Condition: PAKSHAGHATA/PAKSHAVADHAH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Standard Care plus Integrated Yoga and Ayurveda Therapy | (Procedure Reference: kaShAyadhArA)Ashtanga Hridayam, Sutra Sthana, 17th Chapter, (utsAdanam)Ashtanga Hridayam, Sutra Sthana second chapter, (aBya~ggaH)Ashtanga Hridayam, 16th and 17th Chapter, (yoga-bastiH) Charaka Samhita, Siddhi Sthana, 10th Chapter, (piNDasvedaH)Ashtanga Hridayam, Sutra Sthana, 17 Chapter, (Specific Loosening Practices) Asana Pranayama Mudra Bandha Hatha Yoga Pradapika, Chapter 1 and Chapter 2, Procedure details: 1. kaShAyadhArA 2. utsAdanam 3. aBya~ggaH 4. yoga-bastiH 5. piNDasvedaH 6. Specific Loosening Practices 7. Asanas 8. Pranayama 9. Relaxation 10. Meditation) (1) Medicine Name: Kolakulathadi Churna , Reference: Charaka Samhita, Sutra Sthana- 3/18, Route: Topical, Dosage Form: Not Applicable, Dose: 100(g), Frequency: od, Duration: 7 Days(2) Medicine Name: Dhanyamla, Reference: Ashtanga Hridayam, Sutra Sthana-5/79, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 1000(ml), Frequency: od, Duration: 7 Days(3) Medicine Name: Eranadamooladi Kashaya, Pippalyadi Anuvasana basti , Reference: Charaka Samhita, Siddhi Sthana, 10th Chapter, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 450(ml), Frequency: od, Duration: 8 Days(4) Medicine Name: Mustadi Yapana Basthi, Sudhabala Anuvasana basti , Reference: Charaka Samhita, Siddhi Sthana,10th Chapter, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 450(ml), Frequency: od, Duration: 8 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | Standard Care( Treatment As Usual) | Physical Exercise focused on muscle strengthening, stretching and improving flexibility |
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Cerebrovascular event due to arterial stroke both ischemic and hemorrhagic strokes patients, aged over 18 years, First episode of stroke, 3 weeks of post-stroke, Modified Rankin Scale (mRS) scores of 2 to 5 at the time of enrolment, Sufficient cognition to follow instructions
|
|
| ExclusionCriteria |
| Details |
Altered sensorium, Severely aphasic to comprehend simple instructions, Bladder or bowel incontinence, Patients with Cardiovascular disorder and Chronic Kidney Disorder, Patients with Pulmonary dysfunction |
|
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Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Modified Rankin Scale, Modified Ashworth scale, Modified Barthel Index, Berg balance scale, 10 meter walk test |
On the day of enrolment under study, Followup at 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual analogue scale (VAS) |
On the day of enrolment under study, Followup at 3 months |
| Hospital Anxiety and Depression Scale (HADS) |
On the day of enrolment under study, Followup at 3 months |
| Thermography assessment |
On the day of enrolment under study, Followup at 3 months |
Yoga Performance Assessment (YPA)
|
On the day of enrolment under study, Followup at 3 months |
|
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Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| 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="0" 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
|
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Brief Summary
|
This study aims at developing, validating, and testing efficacy of an add on Integrated Yoga and Ayurveda (IYA) therapy program for post-stroke rehabilitation at the National Institute of Mental Health and Neurosciences (NIMHANS), Bengaluru. With stroke being the second leading cause of death globally and a major cause of disability, there is a pressing need for holistic rehabilitation interventions. The study employs a two-part methodology: first, developing and validating the IYA protocol through mixed methods research, and second, conducting a randomized controlled pilot study to test its feasibility. The protocol development phase involves thorough literature review of classical and modern texts, interviews with experienced practitioners, and expert validation using case summaries. The pilot study involves 60 participants (30 in each arm) who meet specific inclusion criteria, including being at least three weeks post-stroke and having sufficient cognition to follow commands. The intervention combines specific yoga practices with traditional Ayurvedic treatments (including Shiropichu, Abhyanga Sveda, and Basti) over a 23-day period. The experimental group will receive this integrated therapy alongside standard care, while the control group will receive standard care alone. The study will measure multiple outcomes using validated assessment tools, including the Modified Rankin Scale for disability, 10 Meter Walk Test, Modified Ashworth Scale for spasticity, Berg Balance Scale for balance assessment, and Hospital Anxiety and Depression Scale for psychological well-being. This research is particularly significant as it attempts to bridge traditional Indian healing systems with modern rehabilitation approaches. The integration of Yoga and Ayurveda offers potential benefits beyond physical rehabilitation, addressing psychological and quality-of-life aspects that are often overlooked in conventional stroke rehabilitation. |