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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low dose HL tablet | Experimental | HL tablet which contains 66.7mg of active compound by oral administration, twice daily in an hour after meal |
|
| high dose HL tablet | Experimental | HL tablet which contains 200mg of active compound by oral administration, twice daily in an hour after meal |
|
| placebo group | Placebo Comparator | Placebo by oral administration, twice daily in an hour after meal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HL tablet | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the change of hepatic fat by Magnetic Resonance spectroscopy (MRS) after administration of HL tablet compared with baseline | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Alanine Transaminase (ALT) | 8 and 12 week | |
| Changes in Asparate Transaminase (AST) | 8 and 12 week | |
| Changes in cholesterol |
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Inclusion Criteria:
Age between 19 and 75
Non-alcoholic fatty liver disease patient
ALT or AST higher than normal range (not over 4 times normal range)
Voluntary agreement and enrollment
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huons | Ansan | Kyeonggi-do | 426791 | South Korea |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| Drug |
|
| 8 and 12 week |
| Changes in triglyceride | 8 and 12 week |
| Changes in free fatty acid | 8 and 12 week |
| Changes in insulin resistance | 8 and 12 week |
| Changes in Body Mass Index (BMI) | 8 and 12 week |