liver disease
Conditions
Interventions
Placebo group:Placebo
Fuzheng Huayu group:Fuzheng Huayu Tablet
Sponsors
Center of Integrative Medicine Beijing Ditan Hospital Capital Medical University Beijing China
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the cumulative incidence of recurrent decompensation events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement rate of liver fibrosis;Quality of Life Score;Cirrhosis improvement rate;the incidence of liver failure;the cumulative incidence of recompensation;the incidence of liver disease-related deaths;the incidence of liver cancer;Rate of improvement in laboratory indicators; | — |
Countries
China
Contacts
Public ContactZhiyun Yang
Center of Integrative Medicine Beijing Ditan Hospital Capital Medical University Beijing China
Outcome results
None listed