Effects of Echinacea in Children

Not Applicable

Withdrawn

• Conditions: Upper Respiratory Infections
• Interventions: Biological: Echinacea purpurea 100 mg/ml in liquid formulation; Other: placebo

• Registration Number: NCT00773435
• Lead Sponsor: University of Washington

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2008-10-14
• Study First Submitted QC: 2008-10-14
• Study First Posted: 2008-10-16
• Study Start: 2008-11
• Status Verified: 2008-12
• Primary Completion: 2009-05
• Study Completion: 2009-08
• Last Update Submitted: 2015-11-30
• Last Update Posted: 2015-12-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1. Echinacea purpurea	Echinacea purpurea 100 mg/ml in liquid formulation	-
2. placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
TNF levels	During first course of study medication

Secondary Outcome Measures

Name	Time	Method
CD25/CD69 activation	120 days
specific and general adverse events	120 days
IL-2, IL-6, IL-12, interferon alpha, interferon gamma, TNF levels	120 days