autoimmune hepatitis
Conditions
Interventions
1:Total glucosides of paeony
2:None
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Patients aged 18-75 years; (2) Diagnosed with AIH based on liver biopsy results and without indication of immunosuppressive therapy; High levels of alanine aminotransferase (ALT) or aspartate aminotransferase (AST)(1-3 X ULN) and/or high levels of IgG(1-1.5 X ULN); Liver biopsy should showed mild lymphocytic piecemeal necrosis (interface hepatitis); (3) Agreed to participate in the trial, and assigned informed consent.
Exclusion criteria
Exclusion criteria: 1. The presence of hepatitis A, B, C, D, or E virus infection; 2. Patients with presence of decompensated cirrhosis; 3. Patients with presence of fulminant liver failure; 4. Primary sclerosing cholangitis, non-alcoholic steatohepatitis, drug induced liver disease or Wilson disease confirmed by liver biopsy; 5. Pregnant and breeding women; 6. Severe disorders of other vital organs, such as severe heart failure, cancer; 7. Parenteral administration of blood or blood products within 6 months before screening; 8. Recent treatment with drugs having known liver toxicity; 9. Taken part in other clinic trials within 6 months before enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| ALT;AST;globulin;IgG;side effects; | — |
Countries
China
Contacts
Public ContactLi Yang
West China hospital, Sichuan University, China
Outcome results
None listed