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

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.