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A research study of a compound containing vitamin E, silymarin and carnitine, three over the counter supplements. The investigators hope to learn if the new supplement can safely and successfully treat fatty liver disease or Non Alcoholic Fatty Liver Disease (NAFLD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RGMA001 | Active Comparator | Proprietary blend of Vitamin E, Silymarin, and Carnitine. |
|
| Sugar Pill | Placebo Comparator | No treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RGMA001 | Dietary Supplement | 3 capsules administered BID once a day. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | Normalization of hepatic AST, ALT, y-GT, albumin, alkaline phosphatase and total bilirubin. | 30 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Vital signs, BMI, symptom directed physical exam, pregnancy tests, laboratory tests (hematology, and chemistry), clinical adverse events, dose modifications and treatment discontinuations related to adverse events or laboratory abnormalities. | 30 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Poulos, MD | Cumberland Research Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cumberland Research Associates, LLC | Fayetteville | North Carolina | 28304 | United States |
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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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| ID | Term |
|---|---|
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D002241 | Carbohydrates |
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| Sugar Pill |
| Dietary Supplement |
Placebo |
|