中国结合医学杂志（英文版）Chinese Journal of Integrative Medicine

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Treatment of HBV Cirrhosis with Fuzheng Huayu Tablet (扶正化瘀片) and Entecavir: Design of a Randomized, Double-Blind, Parallel and Multicenter Clinical Trial

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KeyWord:chronic hepatitis B, liver fibrosis, Fuzheng Huayu Tablet, randomized multicenter trial, trial protocol

Author Name	Affiliation	E-mail
LI Zheng-xin, ZHAO Zhi-min, LIU Ping
LIU Cheng-hai	Institute of Liver Diseases, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai (201203), China	chenghai.liu@outlook.com

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Abstract:

Background: Antiviral therapy can lead to regression of fibrosis in chronic hepatitis B (CHB), but it has a limited effect on cirrhosis. Chinese medicines (CMs), particularly Fuzheng Huayu Tablet (扶正化瘀片, FZHY), have an antifibrotic effect in patients with CHB. Objective: To observe the safety and efficacy of adjunctive FZHY in patients with hepatitis B virus (HBV) cirrhosis, this study was designed as a randomized, placebo-controlled, double-blind, parallel assignment, multicenter trial at 20 centers in China. The total 700 naive patients will be enrolled with compensate cirrhosis due to HBV, and randomly assigned into 2 groups, receiving entecavir (0.5 mg, daily) and FZHY placebo (1.6 g, 3 times a day), or entecavir (0.5 mg, daily ) and FZHY (1.6 g, 3 times a day) , respectively. The primary endpoint was histological improvement at week 48. The secondary outcome is the decline values of liver fibrosis using the noninvasive methods from baseline to week 48 in each arm of the study. Adverse events such as stomach upset, headache, fatigue, dizziness, nausea will be strictly recorded. Discussion: Through this study, we hope to generate a solid evidence for the therapeutic strategy of HBV cirrhosis with a combination of anti-viral such as ETV and anti-fibrotic herbal product such as FZHY. Protocol version: Version 1.3, Date: 2014.12.4. Trial registration number: NCT02241590.