non-alcoholic steatohepatitis
Conditions
Interventions
Strict diet control group:There is no drug treatment, and patients are required to strictly control their diet, formulate a professional diet table and exercise strictly
Diammonium glycyrrhizate enteric capsule single drug group:Diammonium glycyrrhizate enteric capsule 150mg 3/ d, oral, 12 weeks
Vitamin E monotherapy group:Vitamin E 800mg/d, oral, 12 weeks
Application group of diammonium glycyrrhizate enteric capsule and vitamin E:Diammonium glycyrrhizate enteric capsule 150mg 3/ d, oral, 12 weeks , Vitamin E 800mg/d, oral, 12 weeks
Sponsors
First Affiliated Hospital, Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 65 years; 2. According to the diagnostic criteria of fatty liver, there is evidence that liver fat content is high, fat attenuation is increased, and transaminase is increased by > for 1 month; 3. 2 x ULN ALT or less 10 x ULN or less; 4. Women of childbearing age have no history of menopause, have negative urine pregnancy test, and subjects (including male subjects or their spouses) of childbearing age have no plan of pregnancy and take birth control voluntarily from screening to receiving study drug treatment and 3 months after drug withdrawal; 5. Participate in this clinical trial voluntarily, understand and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Systematic application of drugs with clear hepatotoxicity for more than 2 weeks within 6 months before screening; 2. Systemic use of strong immune modulators such as adrenocortical hormone and thymosin for more than 2 weeks or expected during the study period within the first 6 months of screening, except for treatment such as corticosteroid, inhaled steroid and/or topical steroids; 3. Infection with viral disease (HAV, HBV, HCV, HDV, HEV, HIV positive); 4. Previous evidence showed that liver dysfunction was not limited to 2 x ULN or ALT or 10 x ULN;Albumin 50mg/ml;Imaging examination revealed suspicious nodules in liver; 6. Other causes of liver diseases: including viral hepatitis, alcoholic hepatitis, drug hepatitis, autoimmune hepatitis, hepatolenticular degeneration and blood diseases, etc.; 7. Diabetes and thyroid diseases; 8. Uncontrolled hypertension, systolic blood pressure >140mmHg, or diastolic blood pressure >90mmHg, with hypertension-related fundus lesions; 9. Immunodeficiency or autoimmune diseases include existing autoimmune or antibody-mediated diseases, including but not limited to inflammatory bowel diseases, systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, scleroderma, sjogren's syndrome, and autoimmune thrombocytopenia. 10. Mental and nervous system diseases, including psychiatric history or family history of mental diseases (especially depression, depressive tendency, epilepsy, hysteria, etc.); 11. Severe cardiovascular disease (New York, grade III or above, screening for myocardial infarction in the first 6 months, screening for intracavitary angioplasty, unstable angina pectoris, uncontrolled arrhythmia, etc.); 12. Serious diseases of the blood system (various anemia, hemophilia, etc.); 13. Severe kidney disease (chronic kidney disease, renal insufficiency, etc.); 14. Severe digestive system diseases (peptic ulcer, colitis, etc.); 15. Severe respiratory diseases (pulmonary infection, chronic obstructive diseases, interstitial diseases, etc.); 16. Eye diseases (retinal detachment, macular hole, fundus tumors, etc.); 17. Malignant tumor; 18. History of major functional organ transplantation or planned liver transplantation; 19. Patients with allergic constitution and severe allergic history, especially those who are sensitive to experimental drugs and ingredients; 20, history of alcohol or drug abuse (mean alcohol consumption: > : 40g/ day for male and > : 20g/ day for female); 21. Female patients during pregnancy and lactation; 22. Those who must use the drugs prohibited by this study; 23. Participated in other clinical trials 3 months before the trial; 24. Unable or unwilling to provide informed consent or unable to comply with the test requirements; 25. The researchers judged other cases that could not be included in the group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| glutamic oxalacetic transaminase ;glutamic-pyruvic transaminase ;albumin;triglyceride; low density lipoprotein ;Blood glucose;Fat attenuation using Fibroscan;Magnetic Resonance Imaging Proton Density Fat Fraction;IDEAL IQ;T1mapping;T2*mapping;sADC IVIM; | — |
Countries
China
Contacts
Public ContactNIU Junqi
First Affiliated Hospital, Jilin University
Outcome results
None listed