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Efficacy of Sambucol in the Treatment of Influenza

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by Hadassah Medical Organization.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Razei Bar industries Ltd.
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00375115
First received: September 10, 2006
Last updated: November 5, 2007
Last verified: October 2007
History of Changes
  Purpose

The trial will examine the efficacy of sambucol in the treatment of influenza. The primary efficacy endpoint will be the length of time to resolution of influenza illness.The double blind trial will be conducted at the Personnel Clinic, and at the Clinical virology Unit, Hadassah University Hospital, and will include 100 patients with laboratory-confirmed influenza infection, 50 in the sambucol and 50 in the placebo study arm.


Condition Intervention Phase
Influenza
 Drug: Sambucol
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Efficacy of Sambucol on the Length of Time to Resolution of Influenza Illness

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • The length of time to resolution of influenza illness

Estimated Enrollment: 100
Study Start Date: September 2006
Estimated Study Completion Date: September 2009
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Fever ≥ 380C.
  • The presence of at least one of the following respiratory symptoms: cough, sore throat, nasal congestion/ runny nose.
  • The presence of at least one of the following systemic symptoms: headache, fatigue, myalgia, chills/sweats, malaise.

Exclusion Criteria:

  • Pregnant women or women who cannot exclude pregnancy.

    • Patients with diabetes.
    • Immune-suppressed patients, including patients taking immunosuppressive drugs.
    • Patients with renal failure.
    • Patients who received the recent influenza vaccine.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00375115

Locations
Israel
Hadassah Medical Organization, Jerusalem, Israel
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Razei Bar industries Ltd.
Investigators
Principal Investigator: Dana G Wolf, MD Hadassah Medical Organization
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00375115     History of Changes
Other Study ID Numbers: 360HMO-CTIL
Study First Received: September 10, 2006
Last Updated: November 5, 2007
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 21, 2013