Academic Journal

A Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Investigate Chinese Medicine Neuroaid Efficacy on Stroke Recovery (CHIMES Study)

التفاصيل البيبلوغرافية
العنوان: A Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Investigate Chinese Medicine Neuroaid Efficacy on Stroke Recovery (CHIMES Study)
المؤلفون: Venketasubramanian, N., Chen, C. L. H., Gan, R. N., Chan, B. P. L., Chang, H. M., Tan, S. B., Picard, D., Navarro, J. C., Baroque, A. C., Poungvarin, N., Donnan, G. A., Bousser, M. G.
المصدر: International Journal of Stroke ; volume 4, issue 1, page 54-60 ; ISSN 1747-4930 1747-4949
بيانات النشر: SAGE Publications
سنة النشر: 2009
الوصف: 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. Study registration: ClinicalTrials.gov identifier: NCT00554723.
نوع الوثيقة: article in journal/newspaper
اللغة: English
DOI: 10.1111/j.1747-4949.2009.00237.x
الاتاحة: http://dx.doi.org/10.1111/j.1747-4949.2009.00237.x
http://api.wiley.com/onlinelibrary/tdm/v1/articles/10.1111%2Fj.1747-4949.2009.00237.x
http://journals.sagepub.com/doi/pdf/10.1111/j.1747-4949.2009.00237.x
http://journals.sagepub.com/doi/full-xml/10.1111/j.1747-4949.2009.00237.x
Rights: http://journals.sagepub.com/page/policies/text-and-data-mining-license
رقم الانضمام: edsbas.D8E0DD06
قاعدة البيانات: BASE
الوصف
DOI:10.1111/j.1747-4949.2009.00237.x