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Viusid in Adults With Acute Fever of Viral Etiology

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ClinicalTrials.gov Identifier: NCT01008007
Recruitment Status : Completed
First Posted : November 5, 2009
Last Update Posted : May 18, 2010
Sponsor:
Information provided by:
Catalysis SL

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Fever of Viral Etiology Dietary Supplement: Viusid Drug: Conventional treatment Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of VIUSID Administration on Adults With Acute Fever of Viral Etiology
Study Start Date : September 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: A
Viusid in combination with the conventional treatment for acute fever of viral etiology
 Dietary Supplement: Viusid
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.
Active Comparator: B
Conventional treatment for acute fever of viral etiology
 Drug: Conventional 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.


Outcome Measures
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Primary Outcome Measures :
  1. The platelet count improvement at 6 days (end of the treatment) [ Time Frame: 6 days ]
  2. The leukocyte count improvement at 6 days (end of the treatment) [ Time Frame: 6 days ]
  3. The granulocyte count improvement at 6 days (end of the treatment) [ Time Frame: 6 days ]

Secondary Outcome Measures :
  1. Clinical symptoms disappear during the Viusid administration (6 days). [ Time Frame: 6 days ]
  2. Adverse effects during treatment [ Time Frame: 6 days ]
  3. Hemoglobin level improvement [ Time Frame: 6 days ]
  4. Hematocrit level improvement at 6 days (end of the treatment) [ Time Frame: 6 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01008007


Locations
Cuba
"Salvador Allende" Clinical-Surgical Hospital
Havana City, Havana, Cuba
Sponsors and Collaborators
Catalysis SL
Investigators
Principal Investigator: Mayra R Carrasco García, MD "Salvador Allende" Clinical-Surgical Hospital
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Mayra R. Carrasco García, "Salvador Allende" Clinical-Surgical Hospital
ClinicalTrials.gov Identifier: NCT01008007     History of Changes
Other Study ID Numbers: CAT-0911-CU
First Posted: November 5, 2009    Key Record Dates
Last Update Posted: May 18, 2010
Last Verified: May 2010

Keywords provided by Catalysis SL:
Viusid
Dietary supplements
Acute fever
Viral etiology

Additional relevant MeSH terms:
Fever
Body Temperature Changes
Signs and Symptoms