Effects of Echinacea in Children

University of Washington

Status: Withdrawn

Conditions: Upper Respiratory Infections

Treatments: Other: placebo; Biological: Echinacea purpurea 100 mg/ml in liquid formulation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00773435

5U01AT002400 (U.S. NIH Grant/Contract)

A41256

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 6 to 11 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

1. Echinacea purpurea

Active Comparator group

Treatment:

Biological: Echinacea purpurea 100 mg/ml in liquid formulation

2. placebo

Placebo Comparator group

Treatment:

Other: placebo