Chronic Hepatitis B Cirrhosis/Fibrosis
Conditions
Interventions
Experimental group:Enticavi and BIEJIAJIANWAN pill
control group:Enticavi and BIEJIAJIANWAN simulator
Sponsors
Beijing Ditan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Aged 18-60 years old; (2) HBV DNA > 20IU/ml; (3) Liver biopsy Ishak score = F4 within 6 months, or imaging (color ultrasoundCT or MRI) indicate chronic liver disease, spleens enlarged, or LSM value > 9.0kPa; (4) No antiviral therapy or treatment with entecavir less than 6 months, and no anti-liver fibrosis drugs were taken (anti-fibrosis drugs are: Chinese proprietary drugs that have been listed and have a clear anti-liver fibrosis effect in the manual, including: FUZHENGHUAYU capsule, ANLUOHUAXIAN pill, Compound BIEJIA soft liver tablets, BIEJIAJIANWAN pills, etc); (5) Child-Pugh score < 7 (A level); (6) Meet the diagnostic criteria for blood stasis with Chinese medicine dialectical; (7) Subjects or guardian agreed to participate in the trials and signed the informed consent.
Exclusion criteria
Exclusion criteria: (1) Confirm resistance to nucleoside(acid); (2) Decompensated cirrhosis; (3) Liver cancer, or a-fetoprotein (AFP) > 300ng/ml; (4) Liver histology matches other chronic liver diseases (except fatty liver); (5) Acute and chronic hepatitis infected with other viruses except HBV, HCV infection, HDV infection, autoimmune hepatitis, primary biliary cirrhosis, primary sclerosis cholangitis, genetic metabolic liver disease, drug or toxic hepatitis, alcoholic liver disease; (6) People with a history of mental illness or uncontrollable epilepsy; (7) Uncontrolled diabetics; (8) Patients with concurrent hematologic disease, autoimmune disease; (9) There are systemic underlying diseases such as chronic respiratory failure, circulatory failure, and renal failure, etc; (10) A history of organ (like liver, kidney, lungs, heart) transplantation, or bone marrow and stem cell transplantation; (11) Patients with immune deficiency: such as HIV infection or the use of immunosuppressants or glucocorticoids (such as cyclosporins, thiazolines, adrenal corticosteroids) in the past 3 months, or chemotherapy preparations (such as cyclophosphamide, methotrexate, cancer chemotherapy) and radiotherapy; (12) Pregnant or lactating women and women planning to become pregnant during the study period; (13) People who are allergic to drugs used in research; (14) Participants who are participating in other clinical trials; (15) Patients whose doctor think they are not suitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ishak score of liver biopsy;LSM value; | — |
Secondary
| Measure | Time frame |
|---|---|
| APRI score;FIB-4 Score;liver function (ALT) recurrence rate;HBV DNA response rate;security indicators;intestinal flora; | — |
Countries
China
Contacts
Public ContactDanying Cheng
Outcome results
None listed