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Title: A double-blind, placebo-controlled, randomized, multicenter study to investigate CHInese Medicine Neuroaid Efficacy on Stroke recovery (CHIMES Study)
Authors: N. Venketasubramanian
C. L.H. Chen
R. N. Gan
B. P.L. Chan
H. M. Chang
S. B. Tan
D. Picard
J. C. Navarro
A. C. Baroque
N. Poungvarin
G. A. Donnan
M. G. Bousser
National University Hospital, Singapore
National University of Singapore
National Neuroscience Institute of Singapore
Clinical Trials and Epidemiology Research Unit
Moleac Pte Ltd
University of Santo Tomas Hospital
Mahidol University
The Florey Institute of Neuroscience and Mental Health
Hopital Lariboisiere AP-HP
Keywords: Neuroscience
Issue Date: 25-Feb-2009
Citation: International Journal of Stroke. Vol.4, No.1 (2009), 54-60
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 48h 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. Study registration: identifier: NCT00554723. © 2009 The Author. Journal Compilation © 2009 World Stroke Organization.
ISSN: 17474949
Appears in Collections:Scopus 2006-2010

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