Viusid in Adults With Acute Fever of Viral Etiology - Full Text View

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:

MedlinePlus related topics: Dietary Supplements Fever

U.S. FDA Resources

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.

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 May 22, 2013