Metabolic dysfunction-associated fatty liver disease
Conditions
Interventions
Treatment group:Limonene capsules: administered for 12 weeks, 3 times a day, 5 capsules each time
Control group :Placebo, administered for 12 weeks, 3 times a day, 5 capsules each time
Sponsors
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Those who meet the diagnostic criteria, the criteria to be included in this study are both "Diagnostic Criteria for Fatty Liver Disease in Western Medicine" 2020 Edition and A; (2) Between the ages of 18-65, regardless of gender; (3) Those who can cooperate with various treatments and data measurements according to the treatment cycle, and can persist in completing the test; (4) Those who accept and are willing to sign the informed consent.
Exclusion criteria
Exclusion criteria: Potential subjects who meet the inclusion criteria will be excluded if they meet any of the following: 1. Those who routinely take prescription drugs (except regular contraceptive drugs) or those who use auxiliary Chinese and Western drugs to treat non-alcoholic fatty liver; 2. Patients suffering from viral hepatitis, autoimmune hepatitis, hepatolenticular degeneration, hypothyroidism, infection and biliary tract diseases that cause abnormal liver function; 3. Take hypoglycemic drugs, lipid-lowering drugs (such as statins, fibrates, etc.) and drugs that may affect liver fat content (such as: silybin, ursodeoxycholic acid, bicyclic alcohol, phospholipids) within the past 4 weeks Acylcholine and vitamin E, glucocorticoid); 4. Diabetes, those who have undergone bariatric surgery; 5. Weight gain or loss of 10 kg or more in the past two months; 6. People who are allergic to limonene capsules; or people who are allergic to citrus foods; people who especially like to eat a lot of citrus foods; 7. Patients with severe cardiac insufficiency and malignant tumors; 8. Patients who have a history of mental illness and cannot cooperate with this project; 9. Pregnant and lactating women, or women or men who are willing to become pregnant or give birth during the study; 10. Participate in any other clinical trials; 11. Other situations where the researcher thinks it is inappropriate to participate in this research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Imaging examination: changes in CAP from baseline;changes in BMI from baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in waist-to-hip ratio from baseline;Changes in aspartate transaminase (AST) from baseline;Changes in alanine transaminase (ALT) from baseline;Changes in glutamic transpeptidase (GGT) from baseline;Changes in total cholesterol (TC) from baseline;Changes in Triglyceride (TG) from baseline;Changes in low-density lipoprotein cholesterol (LDLC) from baseline;Changes in High density liptein cholesterol (HDL-C) from baseline;Changes in apolipo protein E (Apo E) from baseline;Changes in insulin from baseline;Changes in blood sugar from baseline;Changes in glycated hemoglobin (GHb) from baseline;Changes in Traditional Chinese of Medicine (TCM) Physique Questionnaire score from baseline;Changes in Short Form 36 physical component summary (SF-36 PCS) score from baseline;Changes in Chronic Liver Disease Questionnaire (CLDQ) score from baseline; | — |
Countries
China
Contacts
Public ContactChen Xiaoyun
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Outcome results
None listed