chronic hepatitis B
Conditions
Interventions
Treatment group:Traditional Chinese Medicine granules?
control group:TCM placebo
Sponsors
Shu Guang Hospital Affiliated Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. hepatitis B surface antigen(HBsAg) was detectable for at least 24 week; 2. untreated with any nucleoside analogues, PEGylated interferon a, or interferon a at least 6 months before screening; 3. HBVDNA=1×10^4 copies/ml; 4. ALT=2×ULN or 1×ULN=ALT<2×ULN and liver-biopsy specimens with a Scheuer necroinflammatory grade of 2 or greater within 12 weeks before randomization; 5. aged from 18 to 65 years old male and female; 6. Signed informed consent.
Exclusion criteria
Exclusion criteria: 1. coinfected with HAV, HCV, HDV, HEV and HIV; 2. hepatocellular carcinoma; other forms of liver disease; 3. pregnant and lactating women; 4. other severe primary disease or mental disorder disease; 5. The rejection and withdrawal criteria were: misincluded or misdiagnosed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| negative conversion rate of HBsAg;descend rate of HBsAg;Liver tissure Knodell HAI score; | — |
Secondary
| Measure | Time frame |
|---|---|
| HBVDNA;liver function;B ultrasound of liver and spleen;TCM Syndrome Scale; | — |
Countries
China
Contacts
Public ContactYue-qiu Gao
Shu Guang Hospital Affiliated Shanghai University of Traditional Chinese Medicine
Outcome results
None listed