Study of NeuroAid In Enhancing Recovery After Stroke

Study Overview
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Brief Summary
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TIERS is a phase II to generate detailed preliminary data on the efficacy of NeuroAid in post-stroke recovery, and to assess the utility of the rehabilitation outcome measure instruments used.

Official Title
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A Double-Blinded, Placebo-Controlled, Randomized Phase II Pilot Study to Investigate the Potential Efficacy of a Traditional Chinese Medicine NeuroAid In Enhancing Recovery After Stroke (TIERS)

Conditions
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Stroke, Cerebral Infarction

Intervention / Treatment
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* Drug: Neuroaid
* Drug: Neuroaid matched Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject had cerebral infarction confirmed by Computed Tomography (CT scan or Magnetic Resonance Imaging (MRI) imaging Presents within 1 month after stroke onset Presents with motor power of from grade 1 - 4/5 in at least one limb Has a pre-stroke modified Rankin score ≤ 1. Age between 21 and 80 years old Female subjects are eligible to participate in the trial if they are of non childbearing potential (hysterectomy or post-menopausal) Subject or legally acceptable representative is willing and able to provide written informed consent Subject and carer are willing and able to comply with investigational drug administration schedule. Exclusion Criteria: Subject has received thrombolysis Subject has evidence of intra-cerebral hemorrhage on brain CT scan or MRI Subject has definite indication for full-dose or long-term anticoagulation therapy Subject has other significant non-ischemic brain lesion which could affect function disability Subject has co-existing systemic diseases: terminal cancer, renal failure (creatinine >200 μmol/L, if known), cirrhosis, severe dementia or psychosis Subject has a history of previous stroke/s Subject has participated in another clinical trial within the last three months Subject has aphasia or any other cognitive disabilities which prevent cooperation with study instructions Subject has dense hemiplegia (grade 0 motor power) Subject has haemoglobin level of <10mg/dl on admission Subject has a history of craniotomy or seizures

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Neuroaid | Drug: Neuroaid<br>* Neuroaid capsules, 4 capsules, three times per day, during one month<br>|
| Placebo Comparator: 2<br>Neuroaid matched placebo | Drug: Neuroaid matched Placebo<br>* Neuroaid matched placebo 4 capsules three times per day during one month<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer assessment |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Independence Measure (FIM) scale |  | 4 weeks and 8 weeks | 
| Fugl-Meyer subscores |  | 4 weeks and 8 weeks | 
| NIHSS and NIHSS subscores |  | 4 weeks and 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Cerebral infarct, Rehabilitation, Double blind Randomized, Placebo controlled, Traditional Chinese Medicine, Neuroaid