chronic hepatitis B with liver fibrosis
Conditions
Interventions
Sponsors
Guangdong Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Agree to participate in this clinical trial and sign the informed consent form; 2. To meet the diagnostic criteria of chronic hepatitis B; 3. It conforms to the diagnostic criteria of TCM syndrome with liver stagnation and spleen deficiency, blood stasis and collateral obstruction in TCM. 4. Aged 18-65 years male and female; 5. The test results meets the following conditions: (1) LSM < 9.4 kpa. (2) ALT < 2ULN. (3) Liver biopsy showed G < 2 and S < 2; if S = 2, patients must voluntarily refuse antiviral treatment with full knowledge, and sign an informed consent to refuse antiviral treatment. 6. Female patients must satisfy: (1) menopause (defined as no menstruation for at least one year) or surgical sterilization, or (2) fertility, but must satisfy: result of blood pregnancy examination before randomization must be negative, and consent to the use of appropriate contraceptive measures must include at least one barrier method of contraception (from the signing of informed consent to the end of the follow-up period), and not breast-feed.
Exclusion criteria
Exclusion criteria: 1. Allergy to the constituents and/or excipients of the drug used in this experiment or allergic constitution; 2. Co- infection with HAV, HCV, HDV, HEV and HIV; 3. Complicated with metabolic or autoimmune liver disease, or drug-induced liver damage, or congenital liver disease; 4. Those who were suspect or confirmed with a history of alcohol, drug or drug abuse; 5. Renal creatinine > upper limit of normal value; 6. Ultrasonography/CT/MR suggests cirrhosis, early cirrhosis or HCC; 7. Complications associated with decompensation of liver function, such as ascites, portal hypertensive related upper gastrointestinal bleeding, hepatic encephalopathy, primary spontaneous peritonitis, hepatorenal syndrome, etc.; 8. Patients with serious primary diseases such as heart, lung, kidney and other important organs and hematopoietic system, such as heart failure classified as Grade II, III and IV by the New York Heart Association, heart pacemaker, chronic obstructive pulmonary disease, chronic kidney disease, type 2 diabetes mellitus, etc.; 9. Those with neurological or mental disorders who are unable to cooperate or unwilling to cooperate; 10. History of diseases affecting drug absorption, distribution and metabolism (such as inflammatory bowel disease, gastrointestinal surgery, chronic pancreatitis, glutenin allergy, vagotomy, etc.); 11. Those who have participated in other clinical trials in the past three months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in liver fibrosis stage;Changes in LSM; | — |
Secondary
| Measure | Time frame |
|---|---|
| changes in TCM symptom score;Comparison of liver function before and after treatment with ALT, AST, ALB and TBIL;Changes in HBV DNA negative conversion rate or HBeAg seroconversion rate or HBsAg changes before and after treatment.;Endpoint events such as decompensation of liver function, HCC, severe liver complications such as ascites, portal hypertension, upper gastrointestinal bleeding, hepatic encephalopathy, hepatorenal syndrome, and primary spontaneous peritonitis;Changes in scores of Chronic Liver Disease Scale (CLDQ) and Chronic Disease Self-Management Scale; | — |
Countries
China
Contacts
Public ContactXiaoling Chi
Guangdong Provincial Hospital of Chinese Medicine
Outcome results
None listed