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

Zheng-xin LI; Zhi-min ZHAO; Ping LIU; Qing-shan ZHENG; Cheng-hai LIU

doi:10.1007/s11655-020-3257-6

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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

Original Article | Updated：2021-09-01

- 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
- 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
- Chinese Journal of Integrative Medicine 2021年27卷第7期页码：509-513
- Affiliations：
  
  1.Institute of Liver Diseases, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai (201203), China
  2.Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai (200000), China
- Author bio：
  
  Prof. LIU Cheng-hai, E-mail: chenghai.liu@outlook.com
- Funds：
  
  Ministry of Science and Technology of the People's Republic of China(2014ZX10005001)
- DOI：10.1007/s11655-020-3257-6
  中图分类号：
- 纸质出版日期：2021-07-01，
  
  网络出版日期：2020-06-22，
  
  录用日期：2019-01-15
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Zheng-xin LI, Zhi-min ZHAO, Ping LIU, 等. 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[J]. Chinese Journal of Integrative Medicine, 2021,27(7):509-513.

Zheng-xin LI, Zhi-min ZHAO, Ping LIU, et al. 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[J]. Chinese Journal of Integrative Medicine, 2021,27(7):509-513.
Zheng-xin LI, Zhi-min ZHAO, Ping LIU, 等. 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[J]. Chinese Journal of Integrative Medicine, 2021,27(7):509-513. DOI： 10.1007/s11655-020-3257-6.

Zheng-xin LI, Zhi-min ZHAO, Ping LIU, et al. 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[J]. Chinese Journal of Integrative Medicine, 2021,27(7):509-513. DOI： 10.1007/s11655-020-3257-6.

摘要

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.

关键词

Keywords

chronic hepatitis Bliver fibrosisFuzheng Huayu Tabletrandomized multicenter trialtrial protocol

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