None listed
Conditions
Interventions
Drug : For 24 weeks, the Test group and the control group will take the clinical investigational drug by oral administration after meals, with Rivac granule (test drug) or placebo (control drug) along
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged 20 or over and under 80 years of age at the time of writing the written consent 2. Patients diagnosed with fatty liver (CAP value >250 dB/m) by Fibroscan test 3. Patients who have signed the subject consent form among the patients who satisfy the above conditions
Exclusion criteria
Exclusion criteria: 1. Patients who meet the criteria for alcoholic fatty liver (in case of exceeding 210 g per week for men and 140 g per week for women for the past 2 years) 2. Patients with liver disease other than fatty liver 3. Cirrhosis patients with reduced liver function (CTP class B and C) 4. Persons taking drugs that can cause fatty liver (thiazolidinedione, SGLT2i class, amiodarone, methotrexate, tamoxifen, valproate, corticosteroids, etc.) 5. A person who is taking a liver function improving agent or hyperlipidemia treatment for the first time within the last 3 months or changing the dose 6. In case of allergic or hypersensitivity reaction to the target drug or its components 7. Patients with malnutrition, starvation, debilitating conditions (including severe infections, patients with severe pre- and post-operative trauma), pituitary insufficiency or adrenal insufficiency 8. Patients receiving or receiving radiation and chemotherapy for malignant tumors for less than 2 years 9. Patients with severe infectious disease, before and after surgery, and severe trauma 10. Patients undergoing gastrointestinal bypass 11. Heart failure (class III-IV in NYHA classification) or uncontrolled arrhythmia within 6 months 12. Those with acute cardiovascular disease within 12 weeks (Patients with a history of unstable angina, myocardial infarction, transient ischemic attack, cerebrovascular disease, coronary artery bypass graft, or coronary intervention) 13. Patients with renal failure, chronic renal disease (estimated glomerular filtration rate <60 mL/min/1.73 m2) or patients on dialysis 14. Anemic patients with an Hb level of less than 10.5 g/dl 15. Patients with congenital abnormality of branched chain amino acid metabolism 16. Patients with genetic problems such as galactose intorlerance, Lapp lactase deficiency or glucose-galactose malabsorption 17. Pregnant women, lactating women, and those who are planning to become pregnant during this clinical trial period or who have reproductive ability who do not agree to the contraceptive method, patients who cannot use an approved method of contraception during the trial period (accepted method of contraception is ), sterilization, oral contraceptives, etc.) Patients who do not agree to the use of appropriate contraceptive methods during the clinical trial period only for women or men of childbearing potential 18. Patients who have taken clinical trial drugs from other clinical trials within 6 months of consent 19. Persons unable to participate in clinical trials due to the judgment of other researchers 20. Persons unable to read consent forms (eg illiterate, foreigners, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average change within and between groups in limb muscle mass (BIA) at 24 weeks after treatment compared to the clinical trial drug Baseline (before taking the drug) | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Liver stiffness values within and between groups compared to the baseline (before taking the drug) after 24 weeks of treatment with the clinical trial drug;Change of Fibrosis Grade by changing Liver Stiffness within and between groups compared to Baseline (before taking the drug) after 24 weeks of treatment with clinical trial drug;Changes in the amount of fatty liver (CAP Value) within and between groups compared to the baseline (before taking the drug) after 24 weeks of treatment with the clinical trial drug;Steatosis Grade change through changes in the amount of fatty liver (CAP Value) within and between groups compared to the baseline (before taking the drug) after 24 weeks of treatment with the clinical trial drug;Change and normalization ratio of AST and ALT (<40IU/L)/serum albumin/prothrombin time (INR) within and between groups compared to the baseline (before taking the drug) after 24 weeks of treatment with the clinical trial drug;Change and normalization ratio of LDL-C/HDL-C/TG (Triglycerides)/Total Cholesterol within and between groups compared to Baseline (before taking the drug) after 24 weeks of treatment with the clinical trial drug;Rate of change and decrease in fasting blood glucose within each group and between groups compared to baseline (before taking the drug) after 24 weeks of treatment with the clinical trial drug (<100) (in case of subjects with diabetes);Rate of change and decrease in HbA1c levels within and between groups (<5.5) compared to baseline (before taking the drug) after 24 weeks of treatment with the clinical trial drug (in case of subjects with diabetes);Changes in Insulin levels within and between groups compared to Baseline (before taking the drug) after 24 weeks of treatment with the clinical trial drug;Changes in body fat mass within and between groups compared to the baseline (before taking the drug) after 24 weeks of treatment with the clinical trial drug | — |
Countries
Korea, Republic of
Contacts
Public ContactSeung Up Kim
Yonsei University Health System, Severance Hospital
Outcome results
None listed