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The purpose of the study is to assess the safety and effect of Viusid (bags of 4 grams) administration in the treatment of acute fever of viral etiology as diagnosed by clinical, hematologic and serologic parameters. The duration of this open and randomized phase 2 clinical trial will be 6 days. The estimated number of persons with acute fever of viral etiology to be recruited and randomized for the study is 200. The primary outcome measure: platelet, leukocyte and granulocyte count will be assessed at the beginning and the end of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Viusid in combination with the conventional treatment for acute fever of viral etiology |
|
| B | Active Comparator | Conventional treatment for acute fever of viral etiology |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Viusid | Dietary Supplement | One Viusid bag (4 grams, orally administered) every 8 hours, for 6 days in combination with the conventional treatment consisting in: intramuscular injection of one bulb of Dipyrone (600 mg) every 8 hours if fever is greater or equal to 38 ºC; intramuscular injection of one bulb of dimenhydrinate (50 mg) every 8 hours if vomiting; oral rehydration solution (8 ounce) after each diarrhea. |
| Measure | Description | Time Frame |
|---|---|---|
| The platelet count improvement at 6 days (end of the treatment) | 6 days | |
| The leukocyte count improvement at 6 days (end of the treatment) | 6 days | |
| The granulocyte count improvement at 6 days (end of the treatment) | 6 days |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical symptoms disappear during the Viusid administration (6 days). | 6 days | |
| Adverse effects during treatment | 6 days | |
| Hemoglobin level improvement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mayra R Carrasco García, MD | "Salvador Allende" Clinical-Surgical Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| "Salvador Allende" Clinical-Surgical Hospital | Havana | La Habana | Cuba |
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| ID | Term |
|---|---|
| C551853 | Viusid |
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| Conventional treatment | Drug | Conventional treatment consisting in: intramuscular injection of one bulb of Dipyrone (600 mg) every 8 hours if fever is greater or equal to 38 ºC; intramuscular injection of one bulb of dimenhydrinate (50 mg) every 8 hours if vomiting; oral rehydration solution (8 ounce) after each diarrhea. |
|
| 6 days |
| Hematocrit level improvement at 6 days (end of the treatment) | 6 days |