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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  
 
Source of Monetary or Material Support  
National Institute of Mental Health and Neurosciences (NIMHANS), Bangalore, KARNATAKA 560029, INDIA  
 
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  
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 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 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:I60-I69||Cerebrovascular diseases. Ayurveda Condition: PAKSHAGHATA/PAKSHAVADHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-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
2Comparator Arm (Non Ayurveda)-Standard Care( Treatment As Usual)Physical Exercise focused on muscle strengthening, stretching and improving flexibility
 
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 
 
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 
 
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
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.

 
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