Viusid in Adults With Acute Fever of Viral Etiology

Phase 2

Completed

• Conditions: Acute Fever of Viral Etiology
• Interventions: Dietary Supplement: Viusid; Drug: Conventional treatment

• Registration Number: NCT01008007
• Lead Sponsor: Catalysis SL

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-11-03
• Study First Submitted QC: 2009-11-03
• Study First Posted: 2009-11-05
• Status Verified: 2010-05
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Last Update Submitted: 2010-05-17
• Last Update Posted: 2010-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Viusid	Viusid in combination with the conventional treatment for acute fever of viral etiology
B	Conventional treatment	Conventional treatment for acute fever of viral etiology

Primary Outcome Measures

Name	Time	Method
The platelet count improvement at 6 days (end of the treatment)	6 days
The leukocyte count improvement at 6 days (end of the treatment)	6 days
The granulocyte count improvement at 6 days (end of the treatment)	6 days

Secondary Outcome Measures

Name	Time	Method
Clinical symptoms disappear during the Viusid administration (6 days).	6 days
Adverse effects during treatment	6 days
Hemoglobin level improvement	6 days
Hematocrit level improvement at 6 days (end of the treatment)	6 days

Trial Locations

Locations (1)

"Salvador Allende" Clinical-Surgical Hospital; 🇨🇺 Havana City, Havana, Cuba