NCT00773435

Brief Summary

The goal of the this study is to determine if Echinacea purpurea stimulates the immune system in children. For the study, 40 healthy children, 6-11 years old will be randomized to receive Echinacea purpurea or placebo for 10 days in 3 consecutive months. Blood samples will be obtained in the children just before starting study medication, during the first course of medication and either just prior to starting the second course of medication or 50 days following the last of the three courses of medication. Markers of immune activity in children receiving Echinacea or placebo will be compared.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2008

Shorter than P25 for not_applicable

Status
withdrawn

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

First Submitted

Initial submission to the registry

October 14, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 16, 2008

Completed
16 days until next milestone

Study Start

First participant enrolled

November 1, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

December 2, 2015

Status Verified

December 1, 2008

Enrollment Period

6 months

First QC Date

October 14, 2008

Last Update Submit

November 30, 2015

Conditions

Upper Respiratory Infections

Keywords

Upper respiratory tract infectionsChildrenEchinaceaPreventionImmune modulation

Outcome Measures

Primary Outcomes (1)

  • TNF levels

    During first course of study medication

Secondary Outcomes (3)

  • CD25/CD69 activation

    120 days

  • IL-2, IL-6, IL-12, interferon alpha, interferon gamma, TNF levels

    120 days

  • specific and general adverse events

    120 days

Study Arms (2)

1. Echinacea purpurea

ACTIVE COMPARATOR
Biological: Echinacea purpurea 100 mg/ml in liquid formulation

2. placebo

PLACEBO COMPARATOR
Other: placebo

Interventions

Echinacea purpurea 100 mg/ml in liquid formulationBIOLOGICAL

10 ml BID for 10 consecutive days at the start of 3 consecutive 30 day periods

1. Echinacea purpurea
placeboOTHER

10 ml PO BID for 10 consecutive days at the beginning of 3 consecutive 30 day periods

2. placebo

Eligibility Criteria

Age6 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy children 6-11 years old
  • Parent/Caregiver who can read and speak English
  • One child per family

You may not qualify if:

  • History of allergic reaction to Echinacea or related species
  • History of asthma
  • History of allergic rhinitis
  • History of autoimmune disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Respiratory Tract Infections

Interventions

Echinacea extract

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract Diseases

Study Officials

  • James A Taylor

    University of Washington

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Pediatrics

Study Record Dates

First Submitted

October 14, 2008

First Posted

October 16, 2008

Study Start

November 1, 2008

Primary Completion

May 1, 2009

Study Completion

August 1, 2009

Last Updated

December 2, 2015

Record last verified: 2008-12