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The purpose of the study is to evaluate whether Viusid, a nutritional supplement, in combination with diet and exercise improve the histological results (steatosis, necro-inflammatory activity and fibrosis) in comparison with diet and exercise, during 24 weeks of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Viusid, a nutritional supplement, in combination with controlled diet and exercise |
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| B | Active Comparator | Controlled diet and exercise |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Viusid | Dietary Supplement | Viusid, a nutritional supplement. Three oral sachets Daily 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| The histological improvement (steatosis, necro-inflammatory activity and fibrosis) at 24 weeks (end of the treatment). | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Alanine aminotransferase levels (end of the treatment), δ-glutamyltransferase levels (end of the treatment), Body weight, Body Mass Index, Waist circumference (end of the treatment) Insulin resistance (HOMA) (end of the treatment) | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adelaida RodrÃguez de Miranda, MD | National Institute of Gastroenterology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute of Gastroenterology | Vedado | La Habana | 10400 | Cuba |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17311621 | Background | Vilar Gomez E, Gra Oramas B, Soler E, Llanio Navarro R, Ruenes Domech C. Viusid, a nutritional supplement, in combination with interferon alpha-2b and ribavirin in patients with chronic hepatitis C. Liver Int. 2007 Mar;27(2):247-59. doi: 10.1111/j.1478-3231.2006.01411.x. |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C551853 | Viusid |
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Hypocaloric Diet with controlled exercise | Other | Modified ADA diet in combination with controlled exercise daily 24 weeks |
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