Nonalcoholic fatty liver disease
Conditions
Interventions
Control group:FTZ simulant 4 capsules per time, 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, gender is not limited; 2. Comply with the diagnostic criteria for nonalcoholic fatty liver disease, B-diagnosis is fatty liver; 3. Liver proton magnetic resonance spectroscopy (1H MRS) liver triglyceride content >= 5% or magnetic resonance IDEAL IQ liver fat determination liver fat ratio >= 5%; 4. Those who have not taken lipid-regulating drugs in the past 4 weeks (statins, fibrates, etc.); 5. Informed consent has been fully understood and informed consent has been signed.
Exclusion criteria
Exclusion criteria: 1. Have a history of drinking and have a weekly ethanol intake of >140g (male) or >70g (female) in the last 6 months. 2. Those with a history of liver disease: chronic hepatitis B, alcoholic fatty liver, drug-induced liver damage, autoimmune hepatitis, hepatolenticular degeneration and cirrhosis. 3. Have the following conditions that can lead to fatty liver: (1) long-term use (> 2 weeks) tamoxifen, amiodarone, sodium valproate, methotrexate, glucocorticoids; (2) application of total parenteral nutrition; (3) suffering from type 2 diabetes, hyperthyroidism, hypothyroidism, Cushing's syndrome, beta lipoprotein deficiency and so on. 4. After improving lifestyle and/or taking effective antihypertensive drugs, blood pressure is still >160/100mmHg. 5. Significant abnormalities in liver and kidney function: AST or ALT >= 2 times the upper limit of normal, serum creatinine or blood urea nitrogen is greater than the upper limit of normal. 6. Significant abnormalities in blood lipid levels: LDL-C >= 4.9 mmol/L (190 mg/dl), and/or TG > 5 mmol/L (440 mg/dl). 7. Suffering from the following serious diseases: (1) Patients with severe pulmonary infection, gastrointestinal bleeding, diabetic ketosis, cardiovascular and cerebrovascular events in the past 1 month; (2) heart failure and grade III or IV cardiac function (NYHA cardiac function grading). 8. Women during pregnancy or lactation. 9. Patients who have participated in other drug clinical trials or are participating in other clinical trials within 3 months prior to the trial. 10. Patients who cannot undergo MRS examination for various reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At 12th, 24th Week, Magnetic resonance examination resonance examination of changes in liver fat content; | — |
Secondary
| Measure | Time frame |
|---|---|
| Absolute fat change index change at the 12th and 24th weekend;Absolute value of liver hardness change at the 12th and 24th weekend;Absolute value of blood lipids (TC, TG, LDL) at the 12th and 24th weekend;Absolute value of blood glucose change 2 hours after meal on the 12th and 24th weekend;Absolute value of HOMA-IR index at the 12th and 24th weekend;Absolute change in body mass index at the 12th and 24th weekend;The absolute value of waist and hip circumference change at the 12th and 24th weekend;Absolute value of body fat percentage change at the 12th and 24th weekend;the scores of TCM Syndrome;the scores of single TCM symptom; | — |
Countries
China
Contacts
Public ContactGuo Jiao
Guangdong Pharmaceutical University
Outcome results
None listed