liver injury caused by chronic hepatitis B
Conditions
Interventions
treatment group:Yi Gan Ming Mu oral liquid, 10ml po t.i.d
control group:polyene phosphatidyl choline 2 pills po t.i.d
Sponsors
Beijing Youan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18-65 years, gender not limited; 2. Complete informed consent voluntarily, and temporarily has no intention to start antiviral treatment; 3. Patients with chronic hepatitis B liver injury, whose diagnostic criteria are accord with "viral hepatitis prevention and control plan" in 2000, and "guideline of the chronic hepatitis B prevention" in 2011 by the Chinese medical association; The specific standard is: 1. with history of chronic hepatitis B is longer than 6 months; 2. serum HBsAg positive, HBeAg positive or negative, anti - HBe positive or negative, HBV DNA positive; 3. ALT is higher than upper limit of normal; 4. liver tissue pathology is accord with diagnosis of chronic hepatitis standards (appendix 1). Diagnosis in accordance with the above standard (which have 1, 2, 3 or 1, 2, 4, can be diagnosed as chronic hepatitis B liver injury).
Exclusion criteria
Exclusion criteria: 1. Hepatitis A, hepatitis C, hepatitis E, CMV, EBV and other virus infection; 2. Other liver damage caused by autoimmune liver disease, drug-induced hepatitis, fatty hepatitis, chemicals and so on. 3. ALT >=200U/L, or the PTA=34.2umol/L; 4. With severe cardiovascular, renal, endocrine, blood system, nerve system disease, mental disease and malignant tumor patients; 5. Drug allergy to Yi Gan Ming Mu oral liquid; 6. Pregnancy and lactation women; 7. Treated with antiviral or liver protection medications in 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| total bilirubin;direct bilirubin;aspartate aminotransferase;alanine aminotransferase;Gamma - glutamate transpeptidase;alkaline phosphatase;albumin; | — |
Secondary
| Measure | Time frame |
|---|---|
| the largest diameter of right hepatic lobe;diameter of portal venous trunk;the spleen diameter;diameter of splenic vein;value of liver stiffness;value of liver steatosis;hyaluronic acid;laminin;? collagen;? collagen;HBV-DNA;HBsAg;HBsAb;HBeAg;HBeAb;HBcAb;triglyceride;high-density lipoprotein;low density lipoprotein;cholesterol;gamma-interferon;alpha-interferon;interleukin 4;interleukin 6;interleukin 8;interleukin 10;Symptoms and signs of TCM quantitative score; | — |
Countries
China
Contacts
Public ContactDuan Zhong-ping
Outcome results
None listed