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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 28, 2014