Acute Fever of Viral Etiology
Conditions
Keywords
Viusid, Dietary supplements, Acute fever, Viral etiology
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTViusid
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.
DRUGConventional treatment
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.
Sponsors
Catalysis SL
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Acute fever of viral etiology with less than 72 hours of progression * Signed informed consent.
Exclusion criteria
* Patients under treatment with other antioxidants. * Inability to swallow the content of Viusid bags
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Clinical symptoms disappear during the Viusid administration (6 days). | 6 days |
| Hematocrit level improvement at 6 days (end of the treatment) | 6 days |
| Adverse effects during treatment | 6 days |
| Hemoglobin level improvement | 6 days |
Countries
Cuba
Outcome results
None listed