Viusid in Adults With Acute Fever of Viral Etiology

May 17, 2010 updated by: Catalysis SL

Effect of VIUSID Administration on Adults With Acute Fever of Viral Etiology

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cuba
    • Havana
      • Havana City, Havana, Cuba
        • "Salvador Allende" Clinical-Surgical Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The platelet count improvement at 6 days (end of the treatment)
Time Frame: 6 days
6 days
The leukocyte count improvement at 6 days (end of the treatment)
Time Frame: 6 days
6 days
The granulocyte count improvement at 6 days (end of the treatment)
Time Frame: 6 days
6 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical symptoms disappear during the Viusid administration (6 days).
Time Frame: 6 days
6 days
Adverse effects during treatment
Time Frame: 6 days
6 days
Hemoglobin level improvement
Time Frame: 6 days
6 days
Hematocrit level improvement at 6 days (end of the treatment)
Time Frame: 6 days
6 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catalysis SL

Investigators

  • Principal Investigator: Mayra R Carrasco García, MD, "Salvador Allende" Clinical-Surgical Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

November 3, 2009

First Submitted That Met QC Criteria

November 3, 2009

First Posted (Estimate)

November 5, 2009

Study Record Updates

Last Update Posted (Estimate)

May 18, 2010

Last Update Submitted That Met QC Criteria

May 17, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAT-0911-CU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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