CHInese Medicine NeuroAid Efficacy on Stroke Recovery

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}.

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