CHInese Medicine NeuroAid Efficacy on Stroke Recovery

Study Overview
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Brief Summary
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CHIMES is a double blind, placebo controlled, randomized, multicenter study to test the hypothesis that NeuroAid is superior to placebo in reducing neurological deficit and improving functional outcome in patients with cerebral infarction of an intermediate range of severity.

Detailed Description
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Stroke is a major cause of death and disability. Previous clinical studies performed in China have shown that NeuroAiD increase stroke patients'recovery in terms of neurological disability and functional outcome{Chen et al,2009}and thus may be beneficial as part of a post-stroke rehabilitation programme. In the CHIMES study,we seek to test the hypothesis that NeuroAiD is superior to a placebo in reducing neurological deficit and improving functional outcome in patients recruited within 72 h after the ischemic stroke with intermediate range of severity {6<_NIHSS<_14}.More details of the study protocol have recently been published {Venketasubramanian et al,2009}.

Official Title
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A Double Blind, Placebo Controlled, Randomized, Multicenter Study to Investigate CHInese Medicine NeuroAid Efficacy on Stroke Recovery

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 is aged 18 years old and above (for Singapore 21 years and above as this is the legal age of consent) Subject is on anti-platelet therapy Subject is presented a pre-stroke Modified Rankin Scale inferior or equal to 1 Female subject is eligible to participate in the trial if she is of non-childbearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post menopausal) Subject or his/her legally acceptable representative is willing to provide written informed consent Subject is presented with cerebral infarction with compatible imaging at Computed Tomography (CT) scan or Magnetic Resonance Imaging (MRI) Time window is less than 72 hours after symptoms onset Subject with cerebral infarction with intermediate severity range: 6 ≤ NIHSS ≤ 14 Exclusion Criteria: Subjects deemed unstable by investigator after thrombolysis treatment Subject has evidence of intra-cerebral hemorrhage on brain CT scan or MRI Subject has a rapidly improving neurological deficit 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 participated in another clinical trial within the last three months

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Experimental: A<br>NeuroAid | Drug: NeuroAid<br>* 4 capsules 3 times daily, for three months<br>* Other names: Danqi Piantan Jiaonang (In China);|
| Placebo Comparator: B<br>NeuroAid matched Placebo | Drug: NeuroAid matched Placebo<br>* NeuroAid matched Placebo, 4 capsules 3 times daily, for three months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution modified Rankin Scale grades for all randomized subjects |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NIHSS, Barthel Index, MMSE |  | 3 months | 

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