A multi-center, prospective, randomized, double-blind, comparative, and placebocontrolled clinical Trial for effect of Livact on Fatty Liver disease patients.
- Conditions
- Diseases of the digestive system
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 90
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
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.)
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method