CHInese Medicine NeuroAid Efficacy on Stroke Recovery

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CHIMES Society
• Collaborator: National Medical Research Council (NMRC), Singapore

Criteria

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