Chronic hepatitis with positive HBeAg
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Match the diagnositc standard of HBeAg positive hepatitis B; 2. Aged 18-65 years; 3. Positive HBV-DNA of serum test; 4. Liver function and HBeAg or live pathology match of the following situations: (1) ALT 2*ULN to 3*ULN and HBeAg 50-100 S/CO (equal to 11.63-24.26 PEIU/ml); (2) ALT 2*ULN to 3*ULN and HBeAg700-1250 S/CO (equal to 190.82-352.81 PEIU/ml) and the cases should not less than 60% of total number of participants; (3) ALT 3*ULN to 5*ULN and HBeAg=4 or atory necrosis>=G2, or rate of liver fibrosis >=S2(5)TBIL=2*ULN), TCM signs standard [C]. The Conference Book of the Fourth International Liver Diseases Conference of World TCM Sociate and Mainland-Taiwan TCM Liver Diseases Conference, Xiamen, 2011.291-292.
Exclusion criteria
Exclusion criteria: (1) Pregnancy or preparing to pregnance women, lactating women, man preparing to insemination; (2) Confirmed multiple infection of hepatitis virus by serum test, none virus caused chronic liver diseases such as Alcoholic liver disease, or cryptogenic hepatitis; (3) combined with cirrhosis (liver fibrosis above S4), liver cancer, hepatic encephalopathy, Water electrolyte and acid-base balance disturbance, gastrointestinal bleeding, severe compications with chronic hepatitis; (4) Severe chronic hepatitis B and chronic severe heparitics; (5) Orginal and/or Secondary cardiovascular and cerebrovascular, lung, kindney, endocrine system, nerve system and blood system diseases; (6) To be participated other clinical studies in past one month; (7) Mental disorder unable to express the own feeling; (8) Mutation of hepatitis B virus; (9) To be with drug resistance variation against Entecavir.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TCM syndrome score;Virus serological indexes: HBeAg, HBeAb;Virus nucleic acid index: HBV DNA; | — |
Countries
China