An interventional study of Echinacea purpurea 100 mg/ml in liquid formulation and placebo in Upper Respiratory Infections, sponsored by University of Washington. Withdrawn. Open to participants aged 6 Years to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-12-02.
Sponsored by University of Washington · Not applicable, Interventional, and Basic science
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.
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.
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Exclusion Criteria:
Biological: Echinacea purpurea 100 mg/ml in liquid formulation
Other: placebo
10 ml BID for 10 consecutive days at the start of 3 consecutive 30 day periods
10 ml PO BID for 10 consecutive days at the beginning of 3 consecutive 30 day periods
TNF levels
Time frame: During first course of study medication
CD25/CD69 activation
Time frame: 120 days
IL-2, IL-6, IL-12, interferon alpha, interferon gamma, TNF levels
Time frame: 120 days
specific and general adverse events
Time frame: 120 days
No study locations are listed for this record.
This study is withdrawn, as verified in Dec 2008. You cannot join it, but the record below documents what was studied.
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University of Washington