Non-alcoholic Fatty Liver Disease
Conditions
Brief summary
This study evaluates the safety and efficacy of HL tablet on reducing hepatic fat in non-alcoholic fatty liver disease patients. The patients are allocated to three groups; low dose, high dose, and placebo control group.
Interventions
DRUGHL tablet
DRUGPlacebo
Sponsors
Huons Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 19 and 75 2. Non-alcoholic fatty liver disease patient * Diagnosed by abdomen ultrasonic examination * Non-drinker (alcohol intake per week : female-under 140g, male-under 210g) 3. ALT or AST higher than normal range (not over 4 times normal range) 4. Voluntary agreement and enrollment
Exclusion criteria
1. The ratio of AST/ALT over 2 2. Type I diabetes mellitus patient 3. Any dysfunction of liver besides non-alcoholic fatty liver disease 4. Alcoholic fatty liver disease patient or heavy drinker 5. Prior treatment with any medicine which affects the treatment of non-alcoholic fatty liver disease within 3 months 6. Patient taking any product which affects the BMI or hyperlipidemia 7. Any dyscrasia that investigator considers not to appropriate for this study 8. Bariatric surgery within 6 months 9. Any disease which is able to change the distribution of cytokines 10. Any treatment that affects liver functions within 1 month 11. Participation in other clinical trials within 3 months 12. Person who can not use MRS 13. Pregnancy or breast-feeding 14. Fertile women who do not use contraception 15. Sensitive to the investigational product 16. Any conditions that the investigator considers not to appropriate for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the change of hepatic fat by Magnetic Resonance spectroscopy (MRS) after administration of HL tablet compared with baseline | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Asparate Transaminase (AST) | 8 and 12 week |
| Changes in cholesterol | 8 and 12 week |
| Changes in triglyceride | 8 and 12 week |
| Changes in Alanine Transaminase (ALT) | 8 and 12 week |
| Changes in insulin resistance | 8 and 12 week |
| Changes in Body Mass Index (BMI) | 8 and 12 week |
| Changes in free fatty acid | 8 and 12 week |
Countries
South Korea
Outcome results
None listed