chronic hepatitis B-related liver fibrosis
Conditions
Interventions
Sponsors
302 Military Hospital of China
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18 to 65 years old, male or female; (2) Consistent with the diagnosis criteria of chronic hepatitis B; (3) Liver fibrosis (liver biopsy) stage S=5 (Ishak score); (4) TCM syndrome type: blood stasis obstructing collaterals, deficiency of qi and blood with toxic heat retention; (5) Not taking over nucleoside antivirals in one year, no drug treatment of liver fibrosis in six months; (6) Signed informed consent.
Exclusion criteria
Exclusion criteria: (1) Complicated with other chronic severe hepatitis, decompensated cirrhosis, liver cancer and other serious or end-stage liver diseases; (2) With uncontrollable primary diseases of heart, kidney, lung, endocrine, blood, metabolism and gastrointestinal tract, or psychosis; (3) Pregnant or lactating women; (4) Patients with allergic constitution or allergic to TCM used; (5) Those who can't take medicine according to regulations, have poor compliance and incomplete data affect the judgment of curative effect and safety; (6) Patients unsuitable to be included in this study in researchers consideration; (7) Co-infection with other viral liver diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver histological changes (fibrosis stage, inflammation grade);Clinical endpoint event; | — |
Secondary
| Measure | Time frame |
|---|---|
| Total survival;Liver stiffness value;Liver function (including ALT, AST, ALB, TBiL, ALP, GGT);Abdominal ultrasound;Virology indicators: five items of hepatitis B, HBV DNA;AFP;Blood routine examination;Quality of life scale;4 items of blood coagulation; | — |
Countries
China
Contacts
Public ContactYong-Ping Yang
302 Military Hospital of China
Outcome results
None listed