Fuzheng Huayu Tablets Reduce the Occurrence of Re-Decompensation Events in Patients With First Decompensation of Hepatitis B-Related Liver Cirrhosis: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fuzheng Huayu tablets, Placebo Comparator.
- Who it may be relevant to
- Registry conditions: Decompensated Hepatitis B Cirrhosis. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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, followed by a 96-week follow-up. The study period will last for a total of 2 years. The cumulative incidence of recurrent decompensation events within 1 year, the cumulative incidence of recompensation within 1 year, the incidence of liver failure, liver cancer, and liver disease-related deaths will be analyzed. The efficacy and safety of Fuzheng Huayu tablets in reducing the recurrence of decompensation events in patients with first-time decompensated hepatitis B cirrhosis will be clarified, providing a basis for clinical practice.
Interventions
- Drug Fuzheng Huayu tablets
Fuzheng Huayu Tablets are composed of various medicinal ingredients such as Salvia miltiorrhiza, Prunus persica seed, Gynostemma pentaphyllum, pine pollen, Cordyceps sinensis, and Schisandra chinensis. They have the functions of promoting blood circulation and removing blood stasis, nourishing the liver and enriching essence, and can be used to treat chronic liver diseases, anti-fibrosis, and patients with liver cirrhosis. - Other Placebo Comparator
placebo combined with conventional antiviral therapy
Primary outcome measures
- the cumulative incidence of recurrent decompensation events [Time frame: 1 year]
Secondary outcome measures (4)
- the cumulative incidence of recompensation [Time frame: 1 year]
- the incidence of liver failure [Time frame: 1 year and 2 year]
- the incidence of liver cancer [Time frame: 1 year and 2 year]
- the incidence of liver disease-related deaths [Time frame: 1 year and 2 year]
Eligibility criteria
Inclusion criteria
- Voluntarily joining the group, able to understand and sign informed consent forms;
- Age range: 18-80 years old, gender not limited;
- HBsAg positive for ≥ 6 months during screening;
- Complies with traditional Chinese medicine syndrome types: blood stasis obstructing collaterals, liver and kidney deficiency syndrome;
- The first decompensated event, which meets the diagnostic criteria for decompensated cirrhosis in the "Diagnosis and Treatment Guidelines for Cirrhosis (2019 Edition)": (1) having diagnostic evidence for cirrhosis; (2) Complications related to portal hypertension may occur, such as ascites, esophageal and gastric variceal bleeding, hepatic encephalopathy, hepatorenal syndrome, etc.
Exclusion criteria
- Merge hepatitis A, C, D, E, and/or HIV infections;
- Merge autoimmune liver disease, alcoholic liver disease, drug-induced liver disease and other liver diseases;
- Patients with combined malignant tumors;
- History of splenectomy and transjugular intrahepatic portosystemic shunt surgery;
- Individuals with neurological and psychiatric disorders, especially those with a history of depression, anxiety, mania, schizophrenia, or a family history of mental illness (especially those with a history of depression or tendencies towards depression);
- Individuals with severe heart, lung, kidney and other organ disorders;
- Individuals who plan to undergo organ transplantation or have already undergone organ transplantation;
- Pregnant or lactating women or those with fertility plans during the study period;
- For those who are allergic to tonifying the body and removing blood stasis, nucleoside (acid) analogues, or drugs, or who meet any contraindications in the research drug instructions;
- Individuals who have taken traditional Chinese medicine such as Fuzheng Huayu within the past 6 months;
- Other situations that have participated in other intervention studies within the previous 3 months or are deemed unsuitable for inclusion by the researchers;
- The population diagnosed with liver cancer 3 months after enrollment.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Yu L, Peng W, Shi W, Ma H, Li J, Zhou Y, Miao J, Hou Y, Wang Q, Yang Z. 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. Front Pharmacol. 2026 Jul 2;17:1828944. doi: 10.3389/fphar.2026.1828944. eCollection 2026. PMID 42465987
Identifiers
NCT: NCT07017426 · BJDHYZYFZHY