Efficacy of Sambucol in the Treatment of Influenza

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. Identifier: NCT00375115
Recruitment Status : Completed
First Posted : September 12, 2006
Last Update Posted : June 12, 2018
Razei Bar industries Ltd.
Information provided by:
Hadassah Medical Organization

Brief Summary:
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 or disease Intervention/treatment Phase
Influenza Drug: Sambucol Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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
Study Start Date : September 2006
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT00375115

Hadassah Medical Organization, Jerusalem, Israel
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Razei Bar industries Ltd.
Principal Investigator: Dana G Wolf, MD Hadassah Medical Organization Identifier: NCT00375115     History of Changes
Other Study ID Numbers: 360HMO-CTIL
First Posted: September 12, 2006    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: October 2007

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