Fatty Liver Clinical Trial
— DL-MAFLD-TCMOfficial title:
Clinical Trial of Limonene on Regulating Metabolism-related Fatty Liver Disease (MAFLD) and Analysis of TCM Constitution
Verified date | October 2021 |
Source | Shanghai Jiao Tong University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 57 |
Est. completion date | October 25, 2021 |
Est. primary completion date | October 25, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Longhua Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Hongsheng Tan | 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 |
China,
Eslam M, Newsome PN, Sarin SK, Anstee QM, Targher G, Romero-Gomez M, Zelber-Sagi S, Wai-Sun Wong V, Dufour JF, Schattenberg JM, Kawaguchi T, Arrese M, Valenti L, Shiha G, Tiribelli C, Yki-Järvinen H, Fan JG, Grønbæk H, Yilmaz Y, Cortez-Pinto H, Oliveira C — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Difference of CRP related to the mechanism of action | The absolute values of changes in the levels of CRP were compared between the two groups before and after treatment. | at baseline, twelve weeks after administration | |
Other | Difference of IL6 related to the mechanism of action | The absolute values of changes in the levels of IL6 were compared between the two groups before and after treatment. | at baseline, twelve weeks after administration | |
Other | Difference of TNF-a related to the mechanism of action | The absolute values of changes in the levels of TNF-a were compared between the two groups before and after treatment. | at baseline, twelve weeks after administration | |
Other | Difference of lipidomics metabolites of blood | The metabolomics and genomics detection methods of ultra-high performance liquid chromatography combined with quadrupole time-of-flight mass spectrometry (UPLC-QTOF-MS) were used to test the serum lipid compounds of all samples. Collect 5 mL of fasting venous blood from the subjects in the morning. Obtain serum samples after centrifugation. And then perform lipidomics test. | at baseline, twelve weeks after administration | |
Other | Adverse Events | Incidence of adverse events. | sixteen weeks | |
Primary | Difference of controlled attenuation parameter (CAP) in liver fat | Changes in controlled attenuation parameter (CAP) in liver fat measured with transient elastography between the drug group and the placebo group. | at baseline and twelve weeks after administration | |
Primary | Difference of rate of BMI index | The percent change of BMI index between the drug group and the placebo group. | at baseline, four, twelve weeks after administration | |
Secondary | Difference of waist circumference | The percent change of waist circumference between the drug group and the placebo group. | at baseline, four, twelve weeks after administration | |
Secondary | Difference of aspartate transaminase (AST) index | The absolute values of changes in the levels of AST was compared between the two groups. Serum AST content of the patients were detected by an automatic biochemical analyzer before and after treatment. | at baseline, four, twelve weeks after administration | |
Secondary | Difference of glutamic transpeptidase (GGT) index | The absolute values of changes in the levels of GGT was compared between the two groups. Serum GGT content of the patients were detected by an automatic biochemical analyzer before and after treatment. | at baseline, four, twelve weeks after administration | |
Secondary | Difference of alanine transaminase (ALT) index | The absolute values of changes in the levels of ALT was compared between the two groups. Serum ALT content of the patients were detected by an automatic biochemical analyzer before and after treatment. | at baseline, four, twelve weeks after administration | |
Secondary | Difference of total cholesterol (TC) index | The absolute values of changes in the levels of TC was compared between the two groups before and after treatment. Serum TC content of the patients were detected by an automatic biochemical analyzer before and after treatment. | at baseline, twelve weeks after administration | |
Secondary | Difference of glycerin trilaurate (TG) index | The absolute values of changes in the levels of TG was compared between the two groups before and after treatment. Serum TG content of the patients were detected by an automatic biochemical analyzer before and after treatment. | at baseline, twelve weeks after administration | |
Secondary | Difference of low-density lipoprotein cholesterol (LDL-C) index | The absolute values of changes in the levels of LDLC was compared between the two groups before and after treatment. Serum LDL-C content of the patients were detected by an automatic biochemical analyzer before and after treatment. | at baseline, twelve weeks after administration | |
Secondary | Difference of high-density liptein cholesterol(HDL-C)index | The absolute values of changes in the levels of HDL-C was compared between the two groups before and after treatment. Serum HDL-C content of the patients were detected by an automatic biochemical analyzer before and after treatment. | at baseline, twelve weeks after administration | |
Secondary | Difference of apolipoprotein E (ApoE) index | The absolute values of changes in the levels of ApoE was compared between the two groups before and after treatment. Serum ApoE content of the patients were detected by an automatic biochemical analyzer before and after treatment. | at baseline, twelve weeks after administration | |
Secondary | Difference of insulin index | The absolute values of changes in the levels of insulin was compared between the two groups before and after treatment. | at baseline, twelve weeks after administration | |
Secondary | Difference of glycated hemoglobin(GHb)index | The absolute values of changes in the levels of GHb was compared between the two groups before and after treatment. | at baseline, twelve weeks after administration | |
Secondary | Difference of blood sugar index | The absolute values of changes in the levels of blood sugar was compared between the two groups before and after treatment. | at baseline, twelve weeks after administration | |
Secondary | Difference of the Short Form 36 physical component summary (SF-36 PCS) score | Using the Telephone Interview for the SF-36 PCS score (range, 0 [worst] to 100 [best]). | at baseline, two,four,six,eight,ten weeks, twelve and sixteen weeks after administration | |
Secondary | Difference of the Chronic Liver Disease Questionnaire (CLDQ) | Using the Telephone Interview for the CLDQ score (range, 0 [worst] to 100 [best]). | at baseline, two,four,six,eight,ten weeks, twelve and sixteen weeks after administration | |
Secondary | Difference of the Traditional Chinese of Medicine ( TCM ) Physique Questionnaire | Using the Telephone Interview for the TCM Physique Questionnaire score (range, 0 [worst] to 100 [best]). | at baseline, two,four,six,eight,ten weeks, twelve and sixteen weeks after administration |
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