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| Sponsors and Collaborators: |
University of Washington National Center for Complementary and Alternative Medicine (NCCAM) |
|---|---|
| Information provided by: | University of Washington |
| ClinicalTrials.gov Identifier: | NCT00773435 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Upper Respiratory Infections |
Biological: Echinacea purpurea 100 mg/ml in liquid formulation Other: placebo |
| Study Type: | Interventional |
| Study Design: | Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment |
| Official Title: | Assessing the in Vivo Effect of Echinacea Purpurea on Markers of Immune Activities in Children |
| Estimated Enrollment: | 40 |
| Study Start Date: | November 2008 |
| Estimated Study Completion Date: | August 2009 |
| Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1. Echinacea purpurea: Active Comparator |
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
|
| 2. placebo: Placebo Comparator |
Other: placebo
10 ml PO BID for 10 consecutive days at the beginning of 3 consecutive 30 day periods
|
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.
Eligibility| Ages Eligible for Study: | 6 Years to 11 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | University of Washington ( James A. Taylor, MD ) |
| Study ID Numbers: | A41256, 5U01AT002400 |
| Study First Received: | October 14, 2008 |
| Last Updated: | December 10, 2008 |
| ClinicalTrials.gov Identifier: | NCT00773435 |
| Health Authority: | United States: Food and Drug Administration |
|
Upper respiratory tract infections Children Echinacea Prevention Immune modulation |
|
Respiratory Tract Diseases Respiratory Tract Infections |
|
Infection |
