Back to resultsViusid in Adults With Acute Fever of Viral Etiology
Primary Purpose
Acute Fever of Viral Etiology
Status
Completed
Phase
Phase 2
Locations
Cuba
Study Type
Interventional
Intervention
Viusid
Conventional treatment
Sponsored by
About this trial
This is an interventional treatment trial for Acute Fever of Viral Etiology focused on measuring Viusid, Dietary supplements, Acute fever, Viral etiology
Eligibility 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
Sites / Locations
- "Salvador Allende" Clinical-Surgical Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A
B
Arm Description
Viusid in combination with the conventional treatment for acute fever of viral etiology
Conventional treatment for acute fever of viral etiology
Outcomes
Primary Outcome Measures
The platelet count improvement at 6 days (end of the treatment)
The leukocyte count improvement at 6 days (end of the treatment)
The granulocyte count improvement at 6 days (end of the treatment)
Secondary Outcome Measures
Clinical symptoms disappear during the Viusid administration (6 days).
Adverse effects during treatment
Hemoglobin level improvement
Hematocrit level improvement at 6 days (end of the treatment)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01008007
Brief Title
Viusid in Adults With Acute Fever of Viral Etiology
Official Title
Effect of VIUSID Administration on Adults With Acute Fever of Viral Etiology
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Catalysis SL
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Fever of Viral Etiology
Keywords
Viusid, Dietary supplements, Acute fever, Viral etiology
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Viusid in combination with the conventional treatment for acute fever of viral etiology
Arm Title
B
Arm Type
Active Comparator
Arm Description
Conventional treatment for acute fever of viral etiology
Intervention Type
Dietary Supplement
Intervention Name(s)
Viusid
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Conventional treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
The platelet count improvement at 6 days (end of the treatment)
Time Frame
6 days
Title
The leukocyte count improvement at 6 days (end of the treatment)
Time Frame
6 days
Title
The granulocyte count improvement at 6 days (end of the treatment)
Time Frame
6 days
Secondary Outcome Measure Information:
Title
Clinical symptoms disappear during the Viusid administration (6 days).
Time Frame
6 days
Title
Adverse effects during treatment
Time Frame
6 days
Title
Hemoglobin level improvement
Time Frame
6 days
Title
Hematocrit level improvement at 6 days (end of the treatment)
Time Frame
6 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mayra R Carrasco García, MD
Organizational Affiliation
"Salvador Allende" Clinical-Surgical Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
"Salvador Allende" Clinical-Surgical Hospital
City
Havana City
State/Province
Havana
Country
Cuba
12. IPD Sharing Statement
Learn more about this trial
Viusid in Adults With Acute Fever of Viral Etiology
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