non-alcoholic fatty liver disease
Conditions
Interventions
Xiaoyu Jiangzhi capsule group:Xiaoyu Jiangzhi capsule taken orally 5 capsules (250mg/ capsule) twice a day with an interval of 12±2 hours for 24 weeks
Placebo group:Xiaoyu Jiangzhi capsule simulator taken orally 5 capsules (250mg/ capsule) twice a day with an interval of 12±2 hours for 24 weeks
Sponsors
Zhongshan Hospital Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Participants must meet the following criteria to be included in the study: 1) Age 18-65; 2) Overweight or obese subjects with BMI=24kg/m² according to the standards of the Expert Consensus on Obesity Prevention and Control of Chinese Residents; 3) Subjects meeting the diagnostic criteria for non-alcoholic fatty liver disease (NAFLD) in the Guidelines for the Prevention and Control of Non-Alcoholic Fatty Liver Disease (2018 Update) with fatty infiltration in the liver by abdominal ultrasound and MRI-PDFF=10%; 4) Subjects with any of the following dyslipidemia: TC (=6.2mmol/L) LDL-C (=4.1mmol/L) HDL-C (< 1.0mmol/L) TG (=2.3mmol/L); 5) Subjects with normal renal function indicators; 6) Subjects who agree to use an effective contraceptive method during the trial and within 1 month after the completion of the trial and do not conceive or cause others to conceive; 7) Subjects who voluntarily participate in clinical trials and sign informed consent the signature of informed consent meets the requirements of GCP.
Exclusion criteria
Exclusion criteria: Potential subjects who meet the inclusion criteria will be excluded if they meet any of the following criteria: 1) Subjects who are allergic to Xiaoyu Jiangzhi capsule and its components; 2) Chronic liver diseases other than NAFLD including hepatitis B hepatitis C autoimmune liver disease drug induced liver disease etc.; 3) Cirrhosis liver decompensation or liver cancer; 4) Subjects with more than 2 weeks of NAFLD related medication history in the year before screening (amiodarone methotrexate systemic glucocorticoids tetracycline tamoxifen larger than hormone replacement doses of estrogen anabolic steroids valproic acid tamoxifen and other hepatotoxic drugs); 5) Subjects who used liver protection drugs (including but not limited to reduced glutathione glucalactone glycyrrhizin preparations niacinamide biphenyl diester liver protection tablets silymarin (bin) polyene phosphatidylcholine S-adenosine methionine ursodeoxycholic acid vitamin E and other Chinese herbs that affect liver function etc.) within 4 weeks before admission; 6) Subjects who used any medication with a defined weight loss/loss effect in the 3 months prior to enrollment or who had a =5% decrease or increase in body weight in the 3 months prior to enrollment; 7) Type 1 and type 2 diabetes; 8) Subjects who received lipid-lowering drugs other than Norfibrate atorvastatin (maximum daily dose no more than 20mg) rosuvastatin (maximum daily dose no more than 10mg); 9) Hyperthyroidism; 10) Subjects with clinical or subclinical hypothyroidism receiving thyroid hormone replacement therapy or untreated; 11) Subjects who had undergone bariatric surgery within 5 years prior to enrollment or had a bariatric surgery plan during the clinical trial; 12) Subjects who took fatty liver control drugs within 2 weeks prior to enrollment; 13) Subjects who continuously drank heavy amounts of alcohol (more than 30 or 20 grams per day for men or women respectively) for more than 3 months in the 1 year before enrollment; 14) Subjects whose alcohol consumption could not be reliably quantified by the researchers; 15) Pregnant women lactating women pregnant subjects subjects without autonomous capacity; 16) Subjects with serum ALT > 3xULN or AST > 3xULN; 17) Subjects with history of malignant hypertension; 18) Poorly controlled hypertension: systolic blood pressure =160mmHg or diastolic blood pressure =100mmHg; 19) Complicated with heart failure arrhythmia myocardial infarction coronary heart disease stroke and other cardiovascular and cerebrovascular diseases; 20) Subjects who underwent percutaneous coronary intervention or coronary artery bypass grafting within 3 months prior to enrollment; 21) Subjects participating in other clinical trials within 30 days prior to screening or during this trial; 22) Subjects that the researcher considers inappropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in MRI-PDFF compared to baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in liver elasticity measured by magnetic resonance elastography (MRE);Change rate of liver fat content measured by MRS compared to baseline;The proportion of patients with MRI-PDFF decreased =30% compared to baseline;Triglycerides cholesterol LDL HDL;MRI-PDFF change rate;Platelet count;Hyaluronic acid laminin Type IV collagen type III precollagen;ALT AST GGT ALP direct bilirubin total bilirubin;Changes in liver fat content measured by magnetic resonance spectroscopy (MRS) compared to baseline; | — |
Countries
China
Contacts
Public ContactMingfeng Xia
Zhongshan Hospital Fudan University
Outcome results
None listed