Viusid in Adults With Acute Fever of Viral Etiology

Acute Fever of Viral Etiology Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01008007
• Other study ID #: CAT-0911-CU
• Status: Completed
• Phase: Phase 2
• First received: November 3, 2009
• Last updated: May 17, 2010
• Start date: September 2009
• Est. completion date: May 2010

Study information

• Verified date: May 2010
• Source: Catalysis SL
• Contact: n/a
• Is FDA regulated: No
• Health authority: Cuba: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Fever of Viral Etiology
• Fever

Intervention

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.

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.

Locations

Country	Name	City	State
Cuba	"Salvador Allende" Clinical-Surgical Hospital	Havana City	Havana

Sponsors (1)

Lead Sponsor	Collaborator
Catalysis SL

Country where clinical trial is conducted

Cuba, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The platelet count improvement at 6 days (end of the treatment)		6 days	No
Primary	The leukocyte count improvement at 6 days (end of the treatment)		6 days	No
Primary	The granulocyte count improvement at 6 days (end of the treatment)		6 days	No
Secondary	Clinical symptoms disappear during the Viusid administration (6 days).		6 days	No
Secondary	Adverse effects during treatment		6 days	Yes
Secondary	Hemoglobin level improvement		6 days	No
Secondary	Hematocrit level improvement at 6 days (end of the treatment)		6 days	No