Viusid in Adults With Acute Fever of Viral Etiology

This study has been completed.
Sponsor:
Information provided by:
Catalysis SL
ClinicalTrials.gov Identifier:
NCT01008007
First received: November 3, 2009
Last updated: May 17, 2010
Last verified: May 2010
  Purpose

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 Intervention Phase
Acute Fever of Viral Etiology
Dietary Supplement: Viusid
Drug: Conventional treatment
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of VIUSID Administration on Adults With Acute Fever of Viral Etiology

Resource links provided by NLM:


Further study details as provided by Catalysis SL:

Primary Outcome Measures:
  • The platelet count improvement at 6 days (end of the treatment) [ Time Frame: 6 days ] [ Designated as safety issue: No ]
  • The leukocyte count improvement at 6 days (end of the treatment) [ Time Frame: 6 days ] [ Designated as safety issue: No ]
  • The granulocyte count improvement at 6 days (end of the treatment) [ Time Frame: 6 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical symptoms disappear during the Viusid administration (6 days). [ Time Frame: 6 days ] [ Designated as safety issue: No ]
  • Adverse effects during treatment [ Time Frame: 6 days ] [ Designated as safety issue: Yes ]
  • Hemoglobin level improvement [ Time Frame: 6 days ] [ Designated as safety issue: No ]
  • Hematocrit level improvement at 6 days (end of the treatment) [ Time Frame: 6 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: September 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: November 3, 2009
Last Updated: May 17, 2010
Health Authority: Cuba: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on April 21, 2014