Safety and Efficacy of HL Tablet in Non-alcoholic Fatty Liver Disease Patients

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Huons Co., Ltd.; Huons Co.,Ltd.

Criteria

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