Liver Fibrosis due to Chronic Hepatitis B Virus Infection
Conditions
Interventions
Control :Antiviral treatment + Kehuang capsule placebo
Experimental:Antiviral treatment + Kehuang capsule
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Adult patients aged 18-65 years old with no restriction on gender. 2) Meet the diagnostic criteria for liver fibrosis: one of the followings: ?the pathological results of liver biopsy assessment meet the Ishak diagnostic criteria for liver fibrosis and at stages 2-5; ?the FibroScan test value (LSM)=9.0 kPa. 3) Chronic hepatitis B patients with clinically confirmed HBsAg positivity. 4) Patients with damp-heat stasis in traditional Chinese medicine. Symptoms: distension or pain in the right upper abdomen, reduced diet, distention and stuffiness in the abdomen, nausea and vomiting, dry and bitter mouth or bad breath, tiredness and weakness, yellow urine, sticky and foul-smelling stools or dry stools, red tongue or petechiae, yellow and greasy coating, and string or smooth pulse. 5) Patients gave informed consent, volunteered to be tested, and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Patients receiving antiviral therapy for chronic hepatitis B (CHB) for less than one year. 2) Patients with liver tumors, hepatobiliary parasitic disease, or cirrhosis in the decompensated stage 3) Patients with combined serious cardiovascular, pulmonary, renal, endocrine, neurological, and hematologic diseases (e.g. ventricular tachyarrhythmia, myocardial infarction, active tuberculosis, severe pulmonary infection, chronic kidney disease, renal insufficiency, various types of severe anemia, hemophilia, malignant tumor, and psychiatric disease). 4) Patients with PLT=60×10^9/L, TBIL>2×ULN, ALT=8×ULN and/or AST=8×ULN, and serum creatinine (Scr)>upper limit of normal reference value. 5) Pregnant or lactating women, participants of childbearing age (including male participants who have heterosexual sex and their female partners of childbearing potential) who have a pregnancy plan or are unwilling to use effective contraception from the screening period to 6 months after discontinuation of the drug. 6) Patients with a history of drug or substance abuse within 6 months prior to the baseline that may affect the evaluation of the test results. 7) Patients with alcoholic liver disease, autoimmune hepatitis (ANA positive), drug addiction, or alcohol dependence. 8) Patients treated with proprietary Chinese medicines that may have antifibrotic effects within 3 months prior to enrollment. 9) Persons who participated in other clinical trials within 3 months before recruitment. 10) Persons with allergies or a history of severe allergies, especially to test drugs and components. 11) Persons with abnormal results in hepatitis C virus antibody, syphilis serum-specific antibody, or HIV antigen/antibodies. 12) Patients who are considered by the investigator to be ineligible to participate in this clinical trial and patients who are uncooperative or poorly compliant for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Transient elastography (FibroScan) LSM (kPa) value; | — |
Secondary
| Measure | Time frame |
|---|---|
| Liver function (ALT, AST, ALB, TBIL, DBIL, ALP, GGT);FIB-4 Index;Improvement in Ishak staging of liver biopsy assessment;Serum liver fibrosis markers: HA, PIIIP, IVC and LN;APRI Score;Cirrhosis progression rate after treatment;Change from baseline in TCM syndrome scores after treatment; | — |
Countries
China
Contacts
Public ContactXiaoyuan Xu
Peking University First Hospital
Outcome results
None listed