TCM is an essential context of the ICH management in Chinese culture. Given the potential benefits of Chinese herbal medicine Zhongfengxingnao formula (ZFXN) in reducing haematoma and bleeding after acute intracerebral hemorrhage (ICH) from fundamental research and small clinical studies, more reliable evidence is required to guide ICH treatment using TCM. This study is designed to evaluate the blinding and physical consistency between the investigational drug and placebo in RCT, taking the trial named Chinese herbal medicine in patients with acute intracerebral hemorrhage (CHAIN) as an example. Therefore the blinding of placebo as well as and physical consistency with investigated TCM in CHAIN trial will be determined. In addition, an assessment method for blinding and physical consistency could be developed for subsequent placebo evaluations.

开始日期2022-09-29

申办/合作机构

广州中医药大学

NCT05066620 / Not yet recruiting临床3期IIT

An Investigator-initiated and Conducted Multicentre, Prospective, Randomised, Double-blinded Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Chinese Herbal Medicine in Patients With Acute Intracerebral Haemorrhage

TCM is an essential context of the ICH management in Chinese culture. Given the potential benefits of Chinese herbal medicine FYTF-919 in reducing haematoma and bleeding after acute ICH from fundamental research and small clinical studies, more reliable evidence is required to guide ICH treatment using TCM. This study aims to determine the effectiveness and safety of TCM in a larger sample of patients with moderate-severe ICH and provide evidence for TCM clinical guidelines on ICH management. The presumed mechanism of action is in promoting the reabsorption of the haematoma and perihematomal oedema in ICH.

开始日期2021-10-01

申办/合作机构

广州中医药大学

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100 项与 FYTF-919 相关的临床结果

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100 项与 FYTF-919 相关的转化医学

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100 项与 FYTF-919 相关的专利（医药）

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项与 FYTF-919 相关的文献（医药）

2024-01-01·Cerebrovascular Diseases

Efficacy and Safety of Chinese Herbal Medicine in Patients with Acute Intracerebral Hemorrhage: Protocol for a Randomized Placebo-Controlled Double-Blinded Multicenter Trial

Article

作者: Cui, Wanzhen ; Xiaoying, Chen ; Xie, Tingting ; Liu, Zhenchuan ; Gan, Changlian ; Song, Lili ; Zhao, Haining ; Anderson, Craig S. ; Zhao, Yang ; Che, Fengyuan ; Guo, Jianwen ; Wan, Yingfeng ; Wang, Ruihua ; Wu, Manli ; Anderson, Craig S ; Guo, Qihua ; Li, Yunke ; Wang, Dou ; Chen, Yanjia ; Chen, Yue ; Zheng, Yanwen ; Zhao, Kai ; Li, Qiang ; Gong, Baoying ; Wang, Xia

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 placebo-controlled 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.

Cerebrovascular Diseases

Statistical Analysis Plan for the Chinese Herbal Medicine in Acute Intracerebral Hemorrhage Trial

Article

作者: Anderson, Craig S. ; Tang, Guanghai ; Al-Shahi Salman, Rustam ; Salman, Rustam Al-Shahi ; Guo, Jianwen ; Anderson, Craig S ; Zhao, Yang ; Hankey, Graeme J. ; Billot, Laurent ; Hankey, Graeme J ; Song, Lili ; Li, Qiang

Introduction: The traditional Chinese medicine herbal compound FYTF-919 (Zhong Feng Xing Nao prescription) may improve outcome from acute intracerebral hemorrhage by reducing brain edema, hematoma absorption, and enhancement of the immune system. We outline the statistical analysis plan (SAP) for the Chinese Herbal medicine in Acute INtracerebral hemorrhage (CHAIN) study. CHAIN is a multicenter, prospective, randomized, double-blind, placebo-controlled trial being undertaken at 20–30 hospitals in China. After the completion of eligibility checks, patients are randomly allocated to FYTF-919 (100 mL per day, oral) or matching placebo over 28 days. A sample size of 1,504 patients is estimated to provide 90% power (α 0.05) for a 0.06 absolute improvement in the primary outcome of utility-weighted modified Rankin scale scores at 90 days, analyzed by general linear regression. Methods: The SAP was developed by the study statistician, principal investigators, international experts, and the study project manager. The plan provides details for analyzing baseline characteristics, patient management, and outcomes. It includes provisions for covariate adjustments, subgroup analysis, the handling missing data, and in the conduct of sensitivity analyses. Discussion: A predefined SAP was established for CHAIN, facilitating transparent and verifiable analysis. The CHAIN SAP was prospectively developed with a focus on maintaining high-quality standards of internal validity to minimize potential analysis biases.

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适应症	最高研发状态	国家/地区	公司	日期
脑出血	临床3期	中国	广州中医药大学	-

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05066620 (Literature) 人工标引	临床3期	脑出血	1,648	FYTF-919	(衊繭積願廠夢鏇鏇壓糧) = 窪衊遞憲繭襯襯窪繭衊構簾糧壓醖顧顧壓餘糧 (構淵築艱願艱壓選窪製 )	不佳	2024-11-12
				Placebo	(衊繭積願廠夢鏇鏇壓糧) = 齋鹽構製醖夢鬱鹹觸襯構簾糧壓醖顧顧壓餘糧 (構淵築艱願艱壓選窪製 )