Status:
COMPLETED
Limonene on Regulating Metabolism-related Fatty Liver Disease (MAFLD) and Analysis of TCM Constitution
Lead Sponsor:
Hongsheng Tan
Collaborating Sponsors:
Shanghai Shen Kang Hospital Development Center
Longhua Hospital
Conditions:
Fatty Liver
Eligibility:
All Genders
18-65 years
Phase:
EARLY_PHASE1
Brief 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 eluc...
Detailed Description
In April 2020, in the famous journal "Journal of Hepatology" in the field of liver disease, an internationally renowned liver disease expert group jointly proposed to replace non-alcoholic fatty liver...
Eligibility Criteria
Inclusion
- Clinical diagnosis and imaging diagnosis of MAFLD and BMI index greater than or equal to 23kg/m2；
- The age of the recruiter is between 18-65 years old;
- Those who can cooperate with various treatments and data measurements according to the treatment cycle, and can persist in completing the test;
- Those who accept and are willing to sign the informed consent.
Exclusion
- Potential recruiters who meet the inclusion criteria will be excluded if they meet any of the following:
- 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;
- Patients suffering from viral hepatitis, autoimmune hepatitis, hepatolenticular degeneration, hypothyroidism, infection, and biliary tract diseases that lead to abnormal liver function;
- 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);
- Patients with diabetes or those who have undergone bariatric surgery;
- People who have gained or lost weight by 10 kg or more in the past two months;
- 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);
- Patients with severe cardiac insufficiency and malignant tumors;
- Patients who have a history of mental illness and cannot cooperate with this project;
- Pregnant and lactating women, or women or men who are willing to become pregnant or give birth during the study;
- Participate in any other clinical trials;
- Other situations where the researcher thinks it is inappropriate to participate in this research.
Key Trial Info
Start Date :
February 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 25 2021
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT04853082
Start Date
February 22 2021
End Date
October 25 2021
Last Update
November 2 2021
Active Locations (1)
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1
Longhua Hospital
Shanghai, Shanghai Municipality, China, 200032