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Effects of Echinacea in Children

NCT ID: NCT00773435

Last Updated: 2015-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-08-31

Brief Summary

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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.

Detailed Description

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This is an application to study the biologic activity of a specific formulation of Echinacea purpurea in children 6-11 years old. The goal of the study is to determine if Echinacea purpurea is associated with activation of immune markers including cytokines such as tumor necrosis factor alpha (TNF), interferon alpha, interferon gamma, and interleukins 2, 6, and 12 (IL-2, IL-6, and IL-12), as well CD25 and CD69 activation. A total of 40 study children will be randomized to receive either the Echinacea purpurea formulation or placebo for 10 consecutive days at the start of 3 consecutive 30-day periods. Blood samples will be obtained at baseline, at the time of "peak" TNF activity, and either 30 or 120 days after beginning the study medication. Prior to beginning this pediatric study "peak" TNF activity will be determined by administering the Echinacea purpurea to 3 adult volunteers for 10 days and doing frequent blood sampling during this period. If it is demonstrated that this formulation of E purpurea has biologic activity, a large randomized controlled trial is planned to determine if E purpurea can prevent upper respiratory tract infection (URI) in children 2-11 years old.

Conditions

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Upper Respiratory Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1. Echinacea purpurea

Group Type ACTIVE_COMPARATOR

Echinacea purpurea 100 mg/ml in liquid formulation

Intervention Type BIOLOGICAL

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

2. placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

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

Interventions

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Echinacea purpurea 100 mg/ml in liquid formulation

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

Intervention Type BIOLOGICAL

placebo

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* History of allergic reaction to Echinacea or related species
* History of asthma
* History of allergic rhinitis
* History of autoimmune disease
Minimum Eligible Age

6 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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James Taylor

Professor, Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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James A Taylor

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Other Identifiers

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5U01AT002400

Identifier Type: NIH

Identifier Source: secondary_id

View Link

A41256

Identifier Type: -

Identifier Source: org_study_id