chronic hepatitis B
Conditions
Interventions
A:0-24 wks: Tiaoganjianpihexue granules or Tiaoganjieduhuashi granules +Adefovir mimic, if HBeAg=60S/CO when recruited, Tiaoganjieduhuashi granules and Adefovir are given
25-48 wks:Tiaoganjianpihexue granules or Tiaoganjieduhuashi granules +Adefovir
49-96 wks: Tiaoganjieduhuashi granules +Adefovir
B:0-48 wks: Tiaoganjianpihexue granule mimic or Tiaoganjieduhuashi granule mimic+ Adefovir
49-96 wks: Adefovir
Sponsors
Dongzhimen Hospital affliated to Beijing university of Chinese medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Patients meet the diagnosis standard of HBeAg-positive chronic hepatitis B 2.103 copy/ml< serum HBV-DNA<= 108 copy/ml3.Aged 18 to 65 years old4.twice of upper limit <= ALT <= 12 times of upper limit5.Patients voluntarily signed the informed consent6.TBIL<= three times of upper limit7.The TCM classification is liver depression and spleen deficiency and damp and heat liver and gull bladder
Exclusion criteria
Exclusion criteria: 1.Pregnant or lactating women, or women or men who have birth plan 2.Hepatitis B virus markers are positive and the ALT< twice of upper limit. 3.Mutated hepatitis B virus. 4.Patients who received anti-viral neucleoside analogs more than 1 year and now were specified as drug resistant or viral mutated. 5.Serological test showed the chronic hepatitis is caused by a combined infection with hepatitis C virus or HIV, non-virus infection (eg. Alcoholic hepatopathy, auto-immune hepatopathy) or cryptogenic hepatitis. 6.Patients combined with hepatic sclerosis (liver fibrosis S4 or higher), liver cancer, Hepatic encephalopathy, disturbance of water-electrolytes and acid-base balance, GI bleeding, and severe complications of chronic hepatitis. 7.chronic severe hepatitis B or chronic hepatitis B (severe degree) 8.Patients with cardiovascular, liver, lung,endocrine, neurological, hematological or kidney disease. 9.Patients participated in other clinical trial. 10.Patients with abnormal mental state and unable to clearly express themselves
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quatified HBVeAg;TCM syndromes score;Quatified HBV-DNA; | — |
Secondary
| Measure | Time frame |
|---|---|
| liver function;liver biopsy;Fatigue self-assessment scale and chronic hepatopathy scale;TCM symptoms and signs;cytotoxic T cell; | — |
Countries
China
Contacts
Public ContactYong'an Ye
Outcome results
None listed