Chronic Hepatitis B
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Gender and sex: 18 to 65 years old (including 18 and 65 years old), male or female; 2. HBsAg positive for at least 6 months; 3. Serum alanine aminotransferase (ALT) between one to five times of upper limit of normal (ULN) and serum total bilirubin less than two times of ULN; 4. Recieved no antiviral treatment in 6 months before enrolled; 5. Syndrome classification in TCM is accumulated damp-heat type or blood stagnation type; 6. Subjects or their legal representatives could understand and sign the informed consent form, communicate with researchers, and cooperate with the study plan.
Exclusion criteria
Exclusion criteria: 1. Decompensated liver cirrhosis; Primary or metastatic liver cancer; Autoimmune liver disease; Drug-induced liver disease; Alcoholic liver disease; Toxic liver damage; Non-alcoholic fatty liver disease; 2. Prothrombin activity less than 50%, blood platelet less than 50E+9/L and/or blood white blood cell less than 3.0E+9/L; 3. Alpha fetal protein greater than 200ng/ml; 4. With history of alcoholism or drug abuse; With history of gastrointestinal ulcer or asthma; With severe endocrine disease, heart disease, pulmonary disease or renal disease; With mental disease; 5. Receiving or having received other experimental drug treatment in 3 months before enrolled; 6. Pregnant woman, lactating mother or woman planning to be pregnant; 7. Unwilling to participate in this study or with other situation not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinical symptoms;liver function tests; | — |
Secondary
| Measure | Time frame |
|---|---|
| HBVDNA concentration;HBsAg titer;HBeAg titer;indicators of liver fibrosis;B ultrasound;liver hardnessvalue in fibroscan; | — |
Countries
China