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CTRI Number  CTRI/2023/04/051853 [Registered on: 21/04/2023] Trial Registered Prospectively
Last Modified On: 21/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Efficacy of Ayurveda Therapeutic Regimen versus Physiotherapy in Post Stroke Rehabilitation - A Randomized controlled trial 
Scientific Title of Study   Efficacy of Ayurveda Therapeutic Regimen versus Physiotherapy on Functional Disability and QoL in Post Stroke Rehabilitation - A prospective Randomized controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Remya E 
Designation  Research Officer Ayurveda 
Affiliation  NARIP, Cheruthuruthy 
Address  Room No. 620 New building National Ayurveda Research Institute for Panchakarma

Thrissur
KERALA
679531
India 
Phone  9447378133  
Fax    
Email  drremyaenair@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Remya E 
Designation  Research Officer Ayurveda 
Affiliation  NARIP, Cheruthuruthy 
Address  Room No. 620 New building National Ayurveda Research Institute for Panchakarma

Thrissur
KERALA
679531
India 
Phone  9447378133  
Fax    
Email  drremyaenair@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Remya E 
Designation  Research Officer Ayurveda 
Affiliation  NARIP, Cheruthuruthy 
Address  Room No. 620 New building National Ayurveda Research Institute for Panchakarma

Thrissur
KERALA
679531
India 
Phone  9447378133  
Fax    
Email  drremyaenair@gmail.com  
 
Source of Monetary or Material Support  
Central Council for Research in Ayurvedic Sciences 
 
Primary Sponsor  
Name  Central Council for Research in Ayurvedic Sciences 
Address  Central Council for Research in Ayurvedic Sciences, Ministry of AYUSH, Jawahar Lal Nehru Bharatiya Evum Homeopathy Anusandhan Bhavan, NO.61-65, D Block, Janakpuri New Delhi - 110058 
Type of Sponsor  Government funding agency 
 
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 Remya E  National Ayurveda Research Institute for Panchakarma, Cheruthuruthy  Room No. 620 New building National Ayurveda Research Institute for Panchakarma, Cheruthuruthy, Thrissur - 679531, Kerala
Thrissur
KERALA 		 9447378133

drremyaenair@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
IEC  Approved 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G968||Other specified disorders of central nervous system. Ayurveda Condition: PAKSHAGHATA/PAKSHAVADHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-PhysiotherapyPatients enrolled in group II will be admitted in NARIP Hospital initially for 14 days. During this period, a qualified physiotherapist will train the subjects daily for 2 sessions in the morning and evening, with a duration of 45 – 60 minutes per session. Set of exercises will be selected depending on the subject’s condition and response, as appropriate and will be advised to the patient for daily home based physio therapy sessions (Two sessions daily – each of 45-60 minutes duration) at
2Intervention ArmProcedure-Sodhana-karma, षोधन-कर्म (Procedure Reference: AH Chikitsa Chapter 21, Procedure details: Purvakarma - Rookshana a) Udvartana with Kolakulathadi churna b) Mashabaladi Kashaya (Oral) c) Vaisvanara Churna (Oral) Pradhana Karma - a) Snehapana with Goghrita b) Abhyanga & Ushmasveda with Dhanwantaram taila c) Virechana with Gandharvahastataila - 30 ml After Sodhana - a) Kayaseka with Dhanwantaram taila - 7 days b) Yogavasti with Ksheerabala - 8 days c)Marshanasya with Anutaila - 7 days d) Shashtika Pinda Sveda - 7 days e) Sirovasti - Dhanwantaram taila - 7 days Follow up - Mashabaladi )
(1) Medicine Name: Gandharvahasta Taila, Reference: AFI, Part-I, 8:12 ; API Part II, 1:46, Route: Oral, Dosage Form: Taila, Dose: 30(ml), Frequency: od, Duration: 75 Days
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients in the age group 30-70 years, with a radiological diagnosis of stroke (chronicity ≥ 3 months but less than 2 years)
2. Subjects with cognitive and/or motor deficits following stroke
3. Ability to follow instructions and perform the study tasks as per the protocol.
 
 
ExclusionCriteria 
Details  1. Participants with a history of multiple strokes, seizures associated with the index ischemic stroke, paralysis/weakness of whole body or global aphasia
2. Current or chronic history of liver or renal diseases, dementia, other neurological disorders such as epilepsy, cerebellar ataxia etc
3. Severe cognitive deficit (MMSE ≤9 point)
4. Hypertension (> 160/100 mm Hg), with or without medication
5. Current or previous history of congestive heart failure, atrial or ventricular arrhythmias, including atrial fibrillation, atrial flutter, ventricular tachycardia, ventricular fibrillation, and Wolff-Parkinson-White syndrome or electrocardiographic findings
6. Uncontrolled diabetes mellitus (HbA1c ≥8%)
7. Any condition that in the view of the investigator would put the patient at risk through participation in the study
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Change in Barthel Index (BI)
2. Changes in cognitive status assessed by the Montreal Cognitive Assessment scale (МоСА)
 		 Baseline, 21st , 45th, 60th, 75th day 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
1. Change in Fugl Meyer Assessment (FMA)
2.Changes in spasticity severity assessed by Modified Ashworth Scale
4. Change in Stroke Specific Quality of Life (SS-QoL)
4. Adverse events
 		 Baseline, 21st , 45th, 60th, 75th day 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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 3 
Date of First Enrollment (India)   10/05/2023 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  		 Not yet published 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

This study is designed as a randomized controlled clinical trial to compare the efficacy of an individualized Ayurvedic therapeutic regimen and Physiotherapy in Post-stroke rehabilitation.    Individualised Ayurvedic Therapeutic regimen will be administered to Group I patients.  They will be admitted in NARIP Hospital  for 45 days for IP treatment, followed by OPD treatment for 30 days. Total study duration is 75 days in both groups.

Patients enrolled in group II will be admitted in NARIP Hospital initially for 14 days. During this period, a qualified physiotherapist will train the subjects daily for 2 sessions in the morning and evening, with a duration of 45 – 60 minutes per session. Set of exercises will be selected depending on the subject’s condition and response, as appropriate and will be advised to the patient for daily home based physio therapy sessions (Two sessions daily – each of 45-60 minutes duration) at the time of discharge (14th day) and during each follow up visit. (On 21st, 45th, 60th and 75th day)

 
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