Autoimmune hepatitis
Conditions
Interventions
Control group:Placebo
Treatment group:Boil-free granule of Paeonia lactiflora
Sponsors
Fifth Medical Center of PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. AIH simplified diagnostic criteria score >=6; 2. AIH with mild inflammation (serum aminotransferase levels 1 × ULN after no less than 12 weeks application of glycyrrhizin preparations; 4. Withhold initiation of immunosuppressive treatment; 5. Patients aged 18-80 years; 6. Subjects voluntarily joined the study, signed written informed consent.
Exclusion criteria
Exclusion criteria: 1. AIH patients with more than moderate inflammation (serum aminotransferase levels > 3 × ULN, immunoglobulin G > 1.5 × ULN and/or moderate or severe interface hepatitis); 2. Patients with acute AIH (ALT and/or AST values > 10 × ULN); 3. Patients with severe AIH (with international normalized ratio >1.5) ; 4. Patients with liver diseases caused by virus, alcoholic, drug, genetic metabolism, etc.; 5. Other autoimmune diseases including overlap syndrome; 6. Patients with severe cardiac and renal insufficiency, uncontrollable cardiovascular and endocrine diseases, malignant tumors, infectious diseases, or psychiatric disorders; 7. Immunosuppressive drugs such as glucocorticosteroids, azathioprine, and morphimecrol were used within 6 months prior to enrollment; 8. Pregnancy or breast-feeding; 9. Those who are unable to receive clinical observation and treatment due to certain factors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ALT value; | — |
Secondary
| Measure | Time frame |
|---|---|
| Normalization rate;Recovery time;AST value;TBiL value;IgG value;Chinese medicine syndrome scores;Number of cases initiating immunosuppressive therapy; | — |
Countries
China
Contacts
Public ContactZhu Yun
Fifth Medical Center of PLA General Hospital
Outcome results
None listed