Paeoniflorin Combination of Hepatoprotective Drugs Versus Hepatoprotective Drugs Only for Auto-immune Hepatitis
Paeoniflorin Combination of Hepatoprotective Drugs Versus Hepatoprotective Drugs Only for Auto-immune Hepatitis
An open-label,prospective, randomized pilot study to evaluate the efficacy, safety and
 tolerability of paeoniflorin, for the treatment of autoimmune hepatitis (AIH) with mild
 necroinflammatory activity on liver biopsy.
Inclusion Criteria:

 -  Patients aged 20-70 years;

 -  Diagnosed with AIH or primary biliary cirrhosis-autoimmune hepatitis overlap syndrome
 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);

 -  High levels of IgG(1-1.5 X ULN);

 -  Liver biopsy showed mild lymphocytic piecemeal necrosis (interface hepatitis);

 -  Agreed to participate in the trial, and assigned informed consent.

 Exclusion Criteria:

 -  The presence of hepatitis A, B, C, D, or E virus infection;

 -  Patients with presence of liver cirrhosis or portal hypertension;

 -  Patients with presence of fulminant liver failure;

 -  Primary sclerosing cholangitis, non-alcoholic steatohepatitis, drug induced liver
 disease or Wilson disease confirmed by liver biopsy;

 -  Pregnant and breeding women;

 -  Severe disorders of other vital organs, such as severe heart failure, cancer;

 -  Parenteral administration of blood or blood products within 6 months before screening;

 -  Recent treatment with drugs having known liver toxicity;

 -  Taken part in other clinic trials within 6 months before screening.