Effects of Echinacea in Children

• CD25/CD69 activation [ Time Frame: 120 days ] [ Designated as safety issue: No ]
• IL-2, IL-6, IL-12, interferon alpha, interferon gamma, TNF levels [ Time Frame: 120 days ] [ Designated as safety issue: No ]
• specific and general adverse events [ Time Frame: 120 days ] [ Designated as safety issue: Yes ]

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.

• Biological: Echinacea purpurea 100 mg/ml in liquid formulation
  10 ml BID for 10 consecutive days at the start of 3 consecutive 30 day periods
• Other: placebo
  10 ml PO BID for 10 consecutive days at the beginning of 3 consecutive 30 day periods

• Active Comparator: 1. Echinacea purpurea
  Intervention: Biological: Echinacea purpurea 100 mg/ml in liquid formulation
• Placebo Comparator: 2. placebo
  Intervention: Other: placebo

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