Study for Optimized protocol of Traditional Chinese Medicine in the Treatment of Chronic Hepatitis B Virus Carriers
- Conditions
- Chronic Hepatitis B
- Registration Number
- ITMCTR1900002617
- Lead Sponsor
- Shenzhen Traditional Chinese Medicine Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Patients meet the diagnostic criteria for chronic HBV carriers
(1) serum HBsAg, HBeAg and HBV-DNA are positive;
(2) patients are fluped 3 times in one year, whose serum ALT, AST are within the normal range;
(3) Fibroscan<7.0 kPa or liver histological examination shows no obvious abnormalities.);
2. The differentiation of traditional Chinese medicine meets spleen-kidney deficiency syndrome;
3. Aged between 30-65 years, patients have been infected HBV for more than 20 years;
4. Serum ALT <=40 U/L;
5. Serum HBV-DNA: >10^5 IU/ml, <10^9 IU/ml;
6. Histological Knodell HAI<4 score, Ishak<=3 score, or Fibroscan<7.0 kPa;
7. Patient sign the informed consents and volunteer to participate in this clinical trial.
1. Patients infect HIV, HCV and HDV;
2. Patients with metabolic or autoimmune liver disease;
3. Patients have a history of alcohol abuse or illicit drugs or participate in other clinical trials of hepatitis drugs within 30 days;
4. Serum ALT and AST levels show abnormality with one years;
5. Patients are treated with nucleoside or interferon for 24 weeks prior to enrollment;
6. Inactive HBsAg carriers;
7. Patients with cirrhosis or patients' AFP are increased;
8. Pregnant or lactating women;
9. Patients with mental disease and other serious organ diseases.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Serum HBsAg;Serum HBeAg;Serum HBV-DNA;
- Secondary Outcome Measures
Name Time Method AFP;Fibroscan;Knodell HAI;Ishak;Color Doppler ultrasound examination;