Publication: A double-blind, placebo-controlled, randomized, multicenter study to investigate CHInese Medicine Neuroaid Efficacy on Stroke recovery (CHIMES Study)
Issued Date
2009-02-25
Resource Type
ISSN
17474949
17474930
17474930
Other identifier(s)
2-s2.0-60549101099
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Mahidol University
Rights Holder(s)
SCOPUS
Bibliographic Citation
International Journal of Stroke. Vol.4, No.1 (2009), 54-60
Suggested Citation
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 A double-blind, placebo-controlled, randomized, multicenter study to investigate CHInese Medicine Neuroaid Efficacy on Stroke recovery (CHIMES Study). International Journal of Stroke. Vol.4, No.1 (2009), 54-60. doi:10.1111/j.1747-4949.2009.00237.x Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/28306
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Title
A double-blind, placebo-controlled, randomized, multicenter study to investigate CHInese Medicine Neuroaid Efficacy on Stroke recovery (CHIMES Study)
Other Contributor(s)
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
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
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: ClinicalTrials.gov identifier: NCT00554723. © 2009 The Author. Journal Compilation © 2009 World Stroke Organization.