Efficacy And Safety of Chinese Herbal Medicine in Patients with Acute Intracerebral Hemorrhage(CHAIN):Protocol for a Randomized Placebo-controlled Double-blinded Multicenter Trial
机构:[1]George Inst Global Hlth China, Beijing, Peoples R China[2]Guangzhou Univ Chinese Med, Guangzhou, Peoples R China[3]Guangzhou Univ Chinese Med, Affiliated Hosp 2, Guangzhou, Peoples R China广东省中医院[4]Liaoning Thrombus Treatment Ctr Integrated Chines, Shenyang, Peoples R China[5]Univ Michigan, Sch Med, Ann Arbor, MI USA[6]Univ New South Wales, George Inst Global Hlth, Sydney, NSW, Australia[7]Linyi Peoples Hosp, Linyi, Shandong, Peoples R China[8]Zhongshan City Peoples Hosp, Zhongshan, Peoples R China[9]Royal Prince Alfred Hosp, Sydney Hlth Partners, Sydney, NSW, Australia
Introduction: The popular traditional Chinese medicine (TCM) compound FYTF-919 (Zhong Feng Xing Nao prescription) may improve outcome from acute intracerebral hemorrhage (ICH) through effects on brain edema, hematoma absorption, and the immune system. This study is to assess whether FYTF-919 is safe and effective as compared to matching placebo treatment in patients with acute ICH. Methods: The ongoing Chinese Herbal medicine in patients with Acute INtracerebral hemorrhage (CHAIN) is a multicenter, prospective, randomized, double-blind placebocontrolled trial of FYTF-919 in patients with acute ICH at 20-30 hospital sites in China. Eligible ICH patients presenting within 48 h after symptom onset are randomly allocated to receive either FYTF-919 (100 mL per day × 28 d, oral) or matching placebo. A sample size of 1,504 patients is estimated to provide 90% power (α 0.05) to detect a ≥20% improvement in average utility-weight scores on the modified Rankin scale (UW-mRS) assessed at 90 days, with 6% non-adherence and 10% lost to follow-up. The primary efficacy outcome is UW-mRS at 90 days. Secondary outcomes include binary measures of the mRS, neurological impairment on the National Institute of Health Stroke Scale, and health-related quality of life on the EuroQol EQ-5D-5L scale at different time points over 6 months of follow-up. The key safety measure is serious adverse events. Conclusion: CHAIN is on schedule to provide reliable evidence over the benefits of a popular herbal TCM for the treatment of acute ICH.
基金:
Key-Area Research and Development Program of Guangdong Province (No.2020B1111100009), Guangzhou Municipal Science and Technology Bureau (No.202102010287), and National Natural Science Foundation of China (81974559).
第一作者机构:[1]George Inst Global Hlth China, Beijing, Peoples R China
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推荐引用方式(GB/T 7714):
Zhao Yang,Cui Wanzhen,Xie Tingting,et al.Efficacy And Safety of Chinese Herbal Medicine in Patients with Acute Intracerebral Hemorrhage(CHAIN):Protocol for a Randomized Placebo-controlled Double-blinded Multicenter Trial[J].CEREBROVASCULAR DISEASES.2023,52:41-41.doi:10.1159/000534761.
APA:
Zhao, Yang,Cui, Wanzhen,Xie, Tingting,Zhao, Kai,Li, Yunke...&Guo, Jianwen.(2023).Efficacy And Safety of Chinese Herbal Medicine in Patients with Acute Intracerebral Hemorrhage(CHAIN):Protocol for a Randomized Placebo-controlled Double-blinded Multicenter Trial.CEREBROVASCULAR DISEASES,52,
MLA:
Zhao, Yang,et al."Efficacy And Safety of Chinese Herbal Medicine in Patients with Acute Intracerebral Hemorrhage(CHAIN):Protocol for a Randomized Placebo-controlled Double-blinded Multicenter Trial".CEREBROVASCULAR DISEASES 52.(2023):41-41