N. VenketasubramanianC. L.H. ChenR. N. GanB. P.L. ChanH. M. ChangS. B. TanD. PicardJ. C. NavarroA. C. BaroqueN. PoungvarinG. A. DonnanM. G. BousserNational University Hospital, SingaporeNational University of SingaporeNational Neuroscience Institute of SingaporeClinical Trials and Epidemiology Research UnitMoleac Pte LtdUniversity of Santo Tomas HospitalMahidol UniversityThe Florey Institute of Neuroscience and Mental HealthHopital Lariboisiere AP-HP2018-09-132018-09-132009-02-25International Journal of Stroke. Vol.4, No.1 (2009), 54-6017474949174749302-s2.0-60549101099https://repository.li.mahidol.ac.th/handle/20.500.14594/28306Rationale: 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.Mahidol UniversityNeuroscienceArticleSCOPUS10.1111/j.1747-4949.2009.00237.x