Effects of Echinacea in Children
Keywords
Abstract
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.
Dates
| Last Verified: | 11/30/2008 |
| First Submitted: | 10/13/2008 |
| Estimated Enrollment Submitted: | 10/13/2008 |
| First Posted: | 10/15/2008 |
| Last Update Submitted: | 11/29/2015 |
| Last Update Posted: | 12/01/2015 |
| Actual Study Start Date: | 10/31/2008 |
| Estimated Primary Completion Date: | 04/30/2009 |
| Estimated Study Completion Date: | 07/31/2009 |
Condition or disease
Intervention/treatment
Biological: 1. Echinacea purpurea
Other: 2. placebo
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: 1. Echinacea purpurea | Biological: 1. Echinacea purpurea 10 ml BID for 10 consecutive days at the start of 3 consecutive 30 day periods |
| Placebo Comparator: 2. placebo | Other: 2. placebo 10 ml PO BID for 10 consecutive days at the beginning of 3 consecutive 30 day periods |
Eligibility Criteria
| Ages Eligible for Study | 6 Years To 6 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | 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 |
Outcome
Primary Outcome Measures
1. TNF levels [During first course of study medication]
Secondary Outcome Measures
1. CD25/CD69 activation [120 days]
2. IL-2, IL-6, IL-12, interferon alpha, interferon gamma, TNF levels [120 days]
3. specific and general adverse events [120 days]
