nonalcoholic steatohepatitis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18-60 years, both genders; 2. Confirmed diagosis of NAFLD; 3. Biopsy-proven NASH or suspected NASH suggested by combination with metabolic syndrome, persistent elevation of serum ALT, or persistent elevation of CK-18; 4. Voluntary informed content and agreement of participating in every visit, examinations and treatment according to the protocol.
Exclusion criteria
Exclusion criteria: 1. ALT elevation above two times the upper limit of normal; 2. Combination with serious primary diseases and mental diseases, including but not limited to cardiovascular and cerebrovascular diseases, hepatic diseases, renal diseases, hematologic diseases, cancers; 3. Comination with type 2 diabetes; 4. Administration of immunosuppressors, PPAR-? agonists and lipid-lowering agents; 5. Allergy to compositions of experimental agents; 6. Pregnancy and lactation, and women who are likely to be pregnant but refuse to keep predefined contraception measures during the study; 7. Mental or legal disability.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HOMA-IR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Peripheral blood T cell subsets;Serum cytokines;Serum adipocytokines;Transcription factor;Hepatic function;CK-18;Self-designed PRO scale; | — |
Countries
China
Contacts
Shanghai University of Traditional Chinese Medicine