Liver Disease
Conditions
Interventions
MASLD Control Group:None
MASLD Fuzhenghuaji Formula Treatment Group:Fuzhenghuaji Formula
HBV Control Group:None
HBV Fuzhenghuaji Formula Treatment Group:Fuzhenghuaji Formula
Sponsors
The Fifth Medical Center of the PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) All patients provided informed consent to participate in this study and signed informed consent forms; (2) Aged 18–65 years, no gender restrictions; (3) Clinical diagnosis of CHB conformed to the 2022 Guidelines for the Prevention and Treatment of Chronic Hepatitis B: HBsAg and/or HBV DNA positive for >6 months; (4) MASLD diagnosis conforms to the "Guidelines for the Prevention and Treatment of Metabolically Associated (Non-Alcoholic) Fatty Liver Disease (2024 Edition)": liver biopsy, imaging studies, or serum biomarkers indicating hepatic steatosis, plus at least one metabolic risk abnormality: overweight/obesity, type 2 diabetes mellitus (T2DM), or metabolic syndrome (MetS); (5) High-risk CHB population for hepatocellular carcinoma (HCC): Age =40 years with family history of HCC or cirrhosis; abnormal HCC-related serological markers (AFP, AFP-L3, GP73, DCP, etc.); imaging-detected hepatic nodules; compensated-stage cirrhosis due to hepatitis B (Child-Pugh Class A) meeting any one of the following criteria; (6) High-risk population for hepatocellular carcinoma (HCC) with moderate-to-severe alcoholic steatohepatitis (MASLD): FIB-4 score > 2.67; (7) Traditional Chinese Medicine (TCM) pattern identification: phlegm-stasis mutual entanglement syndrome.
Exclusion criteria
Exclusion criteria: (1) Patients with severe or end-stage liver disease such as chronic severe hepatitis, decompensated cirrhosis, or hepatocellular carcinoma; (2) Patients with other liver diseases, including alcoholic liver disease, fatty liver disease, autoimmune liver disease, and metabolic liver disease; (3) Pregnant or lactating women, and patients planning pregnancy in the near future; (4) Patients with allergic constitutions; (5) Use of other drugs significantly affecting the immune system, such as thymosin, immunosuppressants, or glucocorticoids; (6) Patients with uncontrolled severe underlying conditions affecting the heart, kidneys, lungs, endocrine system, blood, metabolism, or gastrointestinal tract; psychiatric disorders; or autoimmune diseases; (7) Concurrent infection with other viral hepatitis (hepatitis A, C, D, E, EBV-associated hepatitis, CMV-associated hepatitis); (8) Individuals with ongoing alcoholism or substance abuse; (9) Long-term users of hepatotoxic medications; (10) Subjects deemed ineligible for this trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LSM-HCC Score;FIB-4 Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of liver cancer;Liver hardness value;Traditional Chinese Medicine Syndrome Score; | — |
Countries
China
Contacts
Public ContactWang Ruilin
The Fifth Medical Center of the PLA General Hospital
Outcome results
None listed