title: A double-blind, placebo-controlled, randomized, multicenter study to investigate CHInese Medicine Neuroaid Efficacy on Stroke recovery (CHIMES Study).
abstract: Rationale Traditional Chinese Medications(TCM) have been reported to have beneficial effects in stroke patients, but were not rigorously evaluated by GCP standards. Aim This study tests the hypothesis that Neuroaid, a TCM widely used in China post-stroke, is superior to placebo in reducing neurological deficit and improving functional outcome in patients with acute cerebral infarction of an intermediate severity. Design This is a multicenter, randomised, double-blind, placebo-controlled study of Neuroaid in ischemic stroke patients with National Institute of Health Stroke Scale(NIHSS) 6-14 treated within 48 h of stroke onset. Neuroaid or placebo is taken (4 capsules) 3 times daily for 3 months. Treatments are assigned using block randomization, stratified for centers, via a central web-randomization system. With a power of 90% and two-sided test of 5% type I error, a sample size is 874. Allowing for a drop-out rate of up to 20%, 1100 individuals should be enrolled in this study. Study Outcomes The primary efficacy endpoint is the modified Rankin Scale(mRS) grades at 3 months. Secondary efficacy endpoints are the NIHSS score at 3 months; difference of NIHSS scores between baseline and 10 days, and between baseline and 3 months; difference of NIHSS sub-scores between baseline and 10 days, and between baseline and 3 months; mRS at 10 days, 1 month, and 3 months; Barthel index at 3 months; Mini Mental State Examination at 10 days and 3 months. Safety outcomes include complete blood count, renal and liver panels, and electrocardiogram.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier: NCT00554723.
authors.affiliation: Division of Neurology, National University Hospital, Singapore. ramani_nv@nuh.com.sg
authors.forename: N
authors.initials: N
authors.lastname: Venketasubramanian
authors.forename: C L H
authors.initials: CL
authors.lastname: Chen
authors.forename: R N
authors.initials: RN
authors.lastname: Gan
authors.forename: B P L
authors.initials: BP
authors.lastname: Chan
authors.forename: H M
authors.initials: HM
authors.lastname: Chang
authors.forename: S B
authors.initials: SB
authors.lastname: Tan
authors.forename: D
authors.initials: D
authors.lastname: Picard
authors.forename: J C
authors.initials: JC
authors.lastname: Navarro
authors.forename: A C
authors.initials: AC
authors.lastname: Baroque
authors.forename: N
authors.initials: N
authors.lastname: Poungvarin
authors.forename: G A
authors.initials: GA
authors.lastname: Donnan
authors.forename: M G
authors.initials: MG
authors.lastname: Bousser
mesh_terms: D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D006801:Humans; D008516:Medicine, Chinese Traditional / Q000379:methods*; D018696:Neuroprotective Agents / Q000627:therapeutic use*; D012107:Research Design; D020521:Stroke / Q000188:drug therapy*
chemical_list: D004365:Drugs, Chinese Herbal; D018696:Neuroprotective Agents