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Efficacy of Sambucol in the Treatment of Influenza

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2007 by Hadassah Medical Organization.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00375115
First Posted: September 12, 2006
Last Update Posted: November 6, 2007
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.
Collaborator:
Razei Bar industries Ltd.
Information provided by:
Hadassah Medical Organization
  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
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Efficacy of Sambucol on the Length of Time to Resolution of Influenza Illness

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00375115     History of Changes
Other Study ID Numbers: 360HMO-CTIL
First Submitted: September 10, 2006
First Posted: September 12, 2006
Last Update Posted: November 6, 2007
Last Verified: October 2007

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