Effects of Echinacea in Children
关键词
抽象
描述
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.
日期
| 最后验证: | 11/30/2008 |
| 首次提交: | 10/13/2008 |
| 提交的预估入学人数: | 10/13/2008 |
| 首次发布: | 10/15/2008 |
| 上次提交的更新: | 11/29/2015 |
| 最近更新发布: | 12/01/2015 |
| 实际学习开始日期: | 10/31/2008 |
| 预计主要完成日期: | 04/30/2009 |
| 预计完成日期: | 07/31/2009 |
状况或疾病
干预/治疗
Biological: 1. Echinacea purpurea
Other: 2. placebo
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| 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 |
资格标准
| 有资格学习的年龄 | 6 Years 至 6 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | 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 |
结果
主要结果指标
1. TNF levels [During first course of study medication]
次要成果指标
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]
