Fuzheng Huayu tablets reduces the risk of further decompensation after the first decompensation in patients with HBV-related cirrhosis: protocol for a randomized, double-blind, placebo-controlled, multicenter trial.

INTRODUCTION

The first decompensation event of cirrhosis is a critical point of disease progression, and the incidence of further decompensation occurs up to more than 50%. Fuzheng Huayu tablet is used as a classic anti-hepatic fibrosis herbal compound. There is no randomized controlled trial (RCT) combining Fuzheng Huayu tablet with antiviral to prevent the occurrence of further decompensation. The aim of this study was to conduct a prospective randomized, double-blind, placebo-controlled, multicenter study to investigate its safety and efficacy in terms of the risk of further decompensation events in patients with first decompensation, and to fill the gap of evidence-based medicine in this field.

METHODS AND ANALYSIS: This study aims to conduct a prospective, multicenter, double-blind, randomized, placebo-controlled trial. The planned sample size is 432 patients, with the ratio of the Fuzheng Huayu group to the placebo control group being 1:1. Participants will be randomly assigned to the two groups using a stratified block randomization method at the central level. The Fuzheng Huayu group (Fuzheng Huayu tablets combined with conventional antiviral therapy) and the placebo group (placebo combined with conventional antiviral therapy) will be treated for 48 weeks and followed up to 96 weeks. The study period will last for a total of 2 years. The cumulative incidence of further decompensation events within 1-year, the cumulative incidence of recompensation within 1-year, the incidence of liver failure, hepatocellular carcinoma, and liver disease-related deaths will be analyzed.

DISCUSSION: This study will be a prospective, randomized, double-blind, placebo-controlled, multicenter study to investigate the clinical benefit of Fuzheng Huayu tablets in the risk of further decompensation events in patients with first decompensation.

CLINICAL TRIAL REGISTRATION: Clinical Trials.gov, study ID NCT07017426; International Traditional Medicine Clinical Trial Registry, registration number ITMCTR2025001365.