non-alcoholic fatty liver disease (NAFLD)
Conditions
Interventions
FTZ group:FTZ capsules was taken orally 4 capsules 3 times a day
Control group:Simulated FTZ capsules, 4 capsules 3 times a day
Sponsors
The First Affiliated Hospital of Guangdong Pharmaceutical University
Eligibility
Sex/Gender
All
Age
35 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 35-65 years, no gender limit; 2. Meet the diagnostic criteria for non-alcoholic fatty liver disease; 3. Patients who have not taken lipid-regulating drugs (statins, betts, etc.) in the last 4 weeks; 4. Receive a liver biopsy during screening (4 weeks before screening if no biopsy is performed during screening) and 24 weeks after intervention; 5. Fertile men and women of childbearing age must consent to effective contraceptive use during the study period; 6. The informed consent has been fully understood and signed.
Exclusion criteria
Exclusion criteria: 1. A history of alcohol consumption and daily alcohol intake of > 30g (men) or > 20g (women) within the last 6 months. 2. Patients with a history of chronic viral hepatitis B, alcoholic fatty liver disease, drug-induced liver injury, autoimmune hepatitis, hepatolenticular degeneration, cirrhosis, or evidence of uncompensated liver disease (i.e., ascites, varicose bleeding), or hepatocellular carcinoma. 3. Have the following conditions that can lead to fatty liver disease: (1) Long-term use (> 2 weeks) of tamoxifen, amiodarone, sodium valproate, methotrexate, glucocorticoid, etc.; (2) Total parenteral nutrition; (3) Patients with type 2 diabetes mellitus, hyperthyroidism, hypothyroidism, Cushing's syndrome, beta-lipoprotein deficiency, etc. 4. Blood pressure remains greater than 160/100mmHg after lifestyle improvements and/or taking effective antihypertensive medications. 5. Abnormal liver, kidney function and coagulation function: AST or ALT>= 2 times the upper limit of normal, creatinine or blood urea nitrogen greater than the upper limit of normal; Abnormal coagulation function or PLT =4.9mmol/L (190mg/dl), and/or TG > 5mmol/L (440mg/dl). 7. Suffering from the following serious medical conditions: (1) Patients with severe pulmonary infection, gastrointestinal bleeding, diabetic ketosis, cardiovascular and cerebrovascular events within the last 1 month; (2) Heart failure with grade III or IV heart function (New York College of Cardiology grade). 8. Patients who are allergic to FTZ components. 9. Pregnant or lactating patients. 10. Patients who have participated in other drug clinical trials or are participating in other clinical trials within 3 months prior to enrollment in this trial. 11. Patients who cannot undergo liver biopsy or MRI for various reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The changes in the stages and inflammatory classification of hepatofibrosis of hepatogenic hepatosis were observed, and the tissue fat changes, liver cell damage, inflammation of the liver, and the lack of fibrosis were not worsened (yes/ no); | — |
Secondary
| Measure | Time frame |
|---|---|
| Liver fat percentage;Total cholesterol;Body mass index; | — |
Countries
China
Contacts
Public ContactGuo Jiao
The First Affiliated Hospital of Guangdong Pharmaceutical University/ Guangdong Pharmaceutical University
Outcome results
None listed