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: chronic hepatitis B related liver fibrosis inclusion criteria: 1. Aged from 18 to 65 years old, male or female; 2. Consistent with the diagnosis criteria of chronic hepatitis B; 3. liver fibrosis (liver biopsy) stage F >=3 (Ishak), HBVDNA >=104 copies/ml (or >=2000 IU/ml); 4. TCM syndrome type: blood stasis, blood deficiency 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. liver fibrosis (liver biopsy) stage F <3 (Ishak); 2. Combined with other severe chronic hepatitis, cirrhosis, liver cancer and other severe or end-stage liver disease; 3. Accompanied by uncontrollable heart, kidney, lung, endocrine, blood, metabolic and gastrointestinal serious primary disease; or mental illness; 4. pregnant or lactating women; 5. Patients with allergic constitution or allergic to TCM used; 6. Not be prescribed medication, poor compliance, incomplete data affecting the efficacy and safety of those judgments; 7. Patients unsuitable for this trial in Researchers consideration; 8. Co-infection with other viral liver disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver histological changes (fibrosis stage, inflam;three routine examination (blood, urine, stool);electrocardiogram;enal function (Cr, BUN, etc.);myocardial enzymes (CK, CK-MB); | — |
Secondary
| Measure | Time frame |
|---|---|
| liver stiffness values;liver function (including ALT, AST, ALB, TBiL, ALP, GGT;Abdominal ultrasound;Electronic endoscopy;4 items of blood coagulation;blood routine examination;Virology indicators: five items of hepatitis B, HBV DNA, AFP;quality of life scale; | — |
Countries
China
Contacts
Public ContactYong-Ping Yang
302 Military Hospital of China
Outcome results
None listed