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

Launched by ZHIYUN YANG · Jun 5, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called Fuzheng Huayu tablets on patients who have experienced their first episode of decompensated hepatitis B-related liver cirrhosis. Decompensation means that the liver is not functioning well, which can lead to serious complications. The trial aims to see if taking Fuzheng Huayu tablets alongside standard antiviral treatment can reduce the chances of patients experiencing further health crises related to their liver condition over a two-year period.

To participate, individuals must be between 18 and 80 years old, have been diagnosed with hepatitis B for at least six months, and be experiencing their first decompensated event, which could include symptoms like fluid buildup or bleeding. Participants will be randomly assigned to either receive the Fuzheng Huayu tablets or a placebo (a sugar pill with no active medication) for 48 weeks, followed by 96 weeks of follow-up. This means that participants will play a crucial role in helping researchers understand whether this treatment can improve outcomes for patients with this serious liver condition.

Gender

ALL

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.