None listed
Conditions
Interventions
None listed
Sponsors
Daejeon Korean Medicine Hospital of Daejeon University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Paticipants with moderate to severe non-alcoholic fatty liver disease receiving oriental medicine treatment, having a CAP score = 260 dB/M on a fibroscan. 2. Participants who, after receiving a detailed explanation about this clinical trial and voluntarily decide to participate and provide written consent.
Exclusion criteria
Exclusion criteria: 1.Those with an average alcohol intake of 210g/week (equivalent to 4 bottles of soju) or more within 3 months before the screening test. 2. Carriers of Type B or C viruses. 3. Individuals with liver cirrhosis, liver cancer, or signs of liver cancer. 4. Those suffering from diseases that can cause fatty liver disease, including: Wilson's disease, Lipodystrophy, Abetalipoproteinemia 5. Individuals taking drugs known to cause fatty liver disease or drugs that may affect lipid metabolism or cause liver damage (mipomersen, lomitapide, amiodarone, methotrexate, tamoxifen, valproate, steroids, antiretroviral drugs, etc.). 6. Those with diseases affecting drug absorption or digestive problems after related surgery. 7. Patients with clinically significant acute or chronic cardiovascular, endocrine, immune, respiratory, renal and urinary, neuropsychiatric, musculoskeletal, inflammatory, and hematological-oncological diseases, gastrointestinal diseases, etc.. (However, patients with common comorbidities of non-alcoholic fatty liver disease, including diabetes, hypertension, and hyperlipidemia, and controlled with medication, are not excluded.) 8. Individuals with one or more medical histories, such as esophageal variceal bleeding, hepatic coma, or ascites, within 12 months before the screening test. 9. Those who have taken medicines or health functional foods related to treat fatty liver within 1 month before the screening test. 10. Individuals who have received antipsychotic medication within 3 months before the screening test. 11. Those suspected of drug addiction. 12. Individuals who are pregnant, breastfeeding, or planning to become pregnant. 13. Individuals who participated in another clinical study within 3 months before the screening test. 14. Those judged by the researcher to be unsuitable for participation in clinical research due to laboratory test results or other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The CAP score measured using a fibroscan | — |
Secondary
| Measure | Time frame |
|---|---|
| Fatty Liver Index (FLI), Liver stiffness measurement (LSM) score, Liver function test;BMI, Waist circumference, Lipid profile (TG, TC, HDL-C, LDL-C), HbA1c, Glucose, Insulin, HOMA-IR | — |
Countries
Korea, Republic of
Contacts
Public ContactChang-Gue Son
Daejeon Korean Medicine Hospital of Daejeon University
Outcome results
None listed