Chronic Hepatitis B
Conditions
Interventions
Sponsors
Guangzhou university of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
30 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. To be aged 30 to 65 years; 2. Chronic Hepatitis B Virus Carriers: HBsAg was positive lasted more than 6 months, HbsAb was negative; HBV-DNA was positive, HBeAg was negative; ALT and AST were less than normal maximum level; 3. Patient's TCM Symptom differentiation was Kidney Deficiency; 4. HBV-DNA>1*10^5 copies/L; 5. Signed inform consent; 6. ALT level was within following range for at least twice in 12 months before enrollment: in male 30-40u/L, infemale 30-40u/L. Two tests' interval was >=14 days and at least one test was done after signing inform consent; 7. Within 24hrs before drug administered, Pregnancy test were negative in women of reproductive age. Conceptive intervention was used until 3 months after the trial was over; 8. Liver biopsy results show no obvious inflammation.
Exclusion criteria
Exclusion criteria: 1. Patients used active antivirus drug in 6 months before enrollment (including interferon and nucleoside analogue, etc.); Patients have received antivirus therapy, antineoplaston or immuno-regulation therapy (including over- physiological dosed steroid and radial lines); In the process of trial, patients will be excluded if he ask for systemic antivirus treatment; 2. Patients co-infected with type A, C, D hepatitis virus or HIV; 3. Patients with chronic liver disease not caused by HBV; 4. Illicit drug or alcohol abused in 6 months before enrollment (>=20g in female and >=30g in male); 5. Patients participanted in other clinical trials in 12 weeks before screening; 6. Serum ALT or AST was not in normal range in 12 weeks before screening; 7. Patients with liver carcinoma, liver sclerosis or elevated serum alpha-fetoprotein; 8. Patients with cardiovascular disease, cancer or other disease that was not suitable to join in the trial; 9. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Concentration of HBV-DNA;HBeAg seroconversion;HBsAg seroconversion;Serum concentration of aspartate aminotransferas; | — |
Secondary
| Measure | Time frame |
|---|---|
| Liver histological indices; | — |
Countries
China
Contacts
Public ContactDaqiao Zhou
Outcome results
None listed