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Viusid in Adults With Acute Fever of Viral Etiology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01008007
Recruitment Status : Completed
First Posted : November 5, 2009
Last Update Posted : May 18, 2010
Sponsor:
Information provided by:
Catalysis SL

Tracking Information
First Submitted Date  ICMJE November 3, 2009
First Posted Date  ICMJE November 5, 2009
Last Update Posted Date May 18, 2010
Study Start Date  ICMJE September 2009
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 3, 2009)
  • The platelet count improvement at 6 days (end of the treatment) [ Time Frame: 6 days ]
  • The leukocyte count improvement at 6 days (end of the treatment) [ Time Frame: 6 days ]
  • The granulocyte count improvement at 6 days (end of the treatment) [ Time Frame: 6 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01008007 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2009)
  • Clinical symptoms disappear during the Viusid administration (6 days). [ Time Frame: 6 days ]
  • Adverse effects during treatment [ Time Frame: 6 days ]
  • Hemoglobin level improvement [ Time Frame: 6 days ]
  • Hematocrit level improvement at 6 days (end of the treatment) [ Time Frame: 6 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Viusid in Adults With Acute Fever of Viral Etiology
Official Title  ICMJE Effect of VIUSID Administration on Adults With Acute Fever of Viral Etiology
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Fever of Viral Etiology
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: A
    Viusid in combination with the conventional treatment for acute fever of viral etiology
    Intervention: Dietary Supplement: Viusid
  • Active Comparator: B
    Conventional treatment for acute fever of viral etiology
    Intervention: Drug: Conventional treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: November 3, 2009)
200
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Cuba
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01008007
Other Study ID Numbers  ICMJE CAT-0911-CU
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mayra R. Carrasco García, "Salvador Allende" Clinical-Surgical Hospital
Study Sponsor  ICMJE Catalysis SL
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mayra R Carrasco García, MD "Salvador Allende" Clinical-Surgical Hospital
PRS Account Catalysis SL
Verification Date May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP