Safety and Efficacy of HL Tablet in Non-alcoholic Fatty Liver Disease Patients
NCT ID: NCT02491905
Last Updated: 2015-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
69 participants
INTERVENTIONAL
2013-11-30
2015-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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low dose HL tablet
HL tablet which contains 66.7mg of active compound by oral administration, twice daily in an hour after meal
HL tablet
high dose HL tablet
HL tablet which contains 200mg of active compound by oral administration, twice daily in an hour after meal
HL tablet
placebo group
Placebo by oral administration, twice daily in an hour after meal
Placebo
Interventions
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HL tablet
Placebo
Eligibility Criteria
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Inclusion Criteria
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
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
19 Years
75 Years
ALL
No
Sponsors
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Huons Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Huons
Ansan, Kyeonggi-do, South Korea
Countries
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Other Identifiers
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12-HS-HP-09-1
Identifier Type: -
Identifier Source: org_study_id
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