Limonene on Regulating Metabolism-related Fatty Liver Disease (MAFLD) and Analysis of TCM Constitution

• Status: Completed
• Trial end date: 2021-10-25
• Target enrollment: 0
• Participant gender: All

Summary

The prevention and treatment of metabolic-related fatty liver disease (MAFLD) involves many fields in preventive medicine and clinical medicine. So far, western medicine has not yet completed the elucidation of the mechanism of this type of disease, and there is a lack of effective therapeutic drugs.The purpose of this study was to evaluate the effectiveness and safety of limonene capsules (marketed product in China) in the treatment of metabolic-related fatty liver disease and related lipid-lowering mechanisms.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hongsheng Tan
• Collaborators: Hongqiao International Institute of Medicine, Shanghai Tongren Hospital and Faculty of Public Health, Shanghai Jiao Tong University School of Medicine; Longhua Hospital; Shanghai Shen Kang Hospital Development Center

Criteria

Inclusion Criteria:

1. Clinical diagnosis and imaging diagnosis of MAFLD and BMI index greater than or equal to 23kg/m2；

2. The age of the recruiter is between 18-65 years old;

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:

Potential recruiters 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 lead to abnormal liver function;

3. Patients who have taken the following drugs in the past 4 weeks: 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, phosphatidylcholine and vitamin E, glucocorticoid);

4. Patients with diabetes or those who have undergone bariatric surgery;

5. People who have gained or lost weight by 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 (daily dosage more than 100 grams);

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.