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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
West China Hospital
Chengdu, Sichuan, China
Percent of patients that achieve biochemical remission of AIH
Biochemical remission is defined as alanine transaminase(ALT),aspartate transaminase(AST) and immunoglobulin G(IgG) within normal limits
Time frame: Month 6 during treatment with paeoniflorin combination of hepatoprotective drugs or hepatoprotective drugs only
Alanine transaminase (ALT)
Time frame: Month 1, 3, 6
Aspartate transaminase(AST)
Time frame: Month 1, 3, 6
Immunoglobulin G(IgG)
Time frame: Month 1, 3, 6
Globin(GLB)
Time frame: Month 1, 3, 6
Total bilirubin(TB)
Time frame: Month 1, 3, 6
Direct bilirubin(DB)
Time frame: Month 1, 3, 6
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