Study of the Immunologic Effects of Echinacea Purpurea in Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Maximal Level of Tumor Necrosis Factor Alpha (pg/ml)
研究概览
简要总结
The goal of this study is to determine if Echinacea purpurea stimulates the immune system. For the study, 20 healthy adults will be randomized to receive Echinacea purpurea or placebo for 10 days. Blood will be drawn to assess immune markers just before beginning the study medication, during the 10 day course of medication and after completing the course of medication. It is postulated that adults receiving the Echinacea will have evidence of immune stimulation and those receiving placebo will not.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults 21-65 years old
- •If female of child-bearing potential, willing to use contraception to prevent pregnancy
- •Speaks and reads English
- •No use of any medication (other than multivitamins, essential fatty acids or probiotics)
- •Willing to abstain from ingesting edible mushrooms throughout study
- •Willing to eat less than 2 garlic cloves per day throughout study
排除标准
- •Positive pregnancy test or currently breastfeeding
- •History of autoimmune disease
- •History of allergic rhinitis
- •History of physician diagnosed eczema
- •Known allergic reaction to Echinacea or related species, specifically ragweed (Ambrosia), chamomile (Matricaria), goldenrod (Solidago) and sunflower (Helianthus)
- •Use of any medication within 30 days prior to first dose of study medication that is a known inhibitor or inducer of CYP34A
研究组 & 干预措施
Echinacea
干预措施: Echinacea purpurea (Biological)
placebo
干预措施: placebo (Drug)
结局指标
主要结局
Maximal Level of Tumor Necrosis Factor Alpha (pg/ml)
时间窗: 10 days
tumor necrosis factor alpha NK cells and evidence of CD25/69 activation
次要结局
- Maximal Levels of Interferon Alpha (pg/ml)(10 days)
- Maximal Levels of Interleukin 6 (pg/ml)(10 days)
- Maximal Levels of Interleukin 12 (pg/ml)(10 days)
- Maximal CD25/69 Activation (% of NK CD25/69+ Cells)(10 days)
- Adverse Effects(30 days)
- Maximal Levels of Interleukin 2 (pg/ml)(10 days)
研究者
James Taylor
School of Medicine: Pediatrics
University of Washington