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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

Chinese Journal of Integrative Medicine volume 27, pages 509–513 (2021)Cite this article

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.

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Author information

Affiliations

  1. Institute of Liver Diseases, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China

    Zheng-xin Li, Zhi-min Zhao, Ping Liu & Cheng-hai Liu

  2. Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, 200000, China

    Qing-shan Zheng

Authors
  1. Zheng-xin Li
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  2. Zhi-min Zhao
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  3. Ping Liu
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  4. Qing-shan Zheng
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  5. Cheng-hai Liu
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Contributions

Li ZX translated and drafted of the manuscript. Zhao ZM contributed in revising of the manuscript and secretary of the project; Liu P and Zheng QS designed the trial; Liu CH was PI of the project and designed the trial and critically revised English version of the manuscript.

Corresponding author

Correspondence to Cheng-hai Liu.

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Conflict of Interest

None declared.

Supported by Ministry of Science and Technology of the People’s Republic of China (No. 2014ZX10005001)

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Li, Zx., Zhao, Zm., Liu, P. 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. Chin. J. Integr. Med. 27, 509–513 (2021). https://doi.org/10.1007/s11655-020-3257-6

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  • DOI: https://doi.org/10.1007/s11655-020-3257-6

Keywords

  • chronic hepatitis B
  • liver fibrosis
  • Fuzheng Huayu Tablet
  • randomized multicenter trial
  • trial protocol