NCT00375115

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2006

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

September 10, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 12, 2006

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

June 12, 2018

Status Verified

October 1, 2007

First QC Date

September 10, 2006

Last Update Submit

June 11, 2018

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

  • The length of time to resolution of influenza illness

Interventions

SambucolDRUG

Eligibility Criteria

Age20 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization, Jerusalem, Israel

Jerusalem, 91120, Israel

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

black elderberry extract

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Dana G Wolf, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 10, 2006

First Posted

September 12, 2006

Study Start

September 1, 2006

Study Completion

September 1, 2009

Last Updated

June 12, 2018

Record last verified: 2007-10

Locations

IL(1)