3-arm Randomized Controlled Trial Assessing the in Vivo Effect of an Echinacea Purpurea on Immune Markers in Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- Peak Level of TNF Alpha
研究概览
简要总结
The goal of this study is to determine if either of two, commercially available, Echinacea purpurea products stimulate the immune system. For the study, 60 healthy adults will be randomized to receive one of the two Echinacea purpurea products 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 either of the Echinacea products 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
- Triple (Participant, Care Provider, Investigator)
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 adult (based on a screening health questionnaire)
- •Speaks and reads English.
- •If female of child-bearing potential, willing to use contraception to prevent pregnancy during the study.
- •No use of any medication (other than multivitamins, essential fatty acids, oral contraceptives and probiotics) for 2 weeks prior to first dose of study.
- •Willing to abstain from ingesting edible mushrooms for 2 weeks prior and throughout study.
- •Willing to eat less than 2 garlic cloves per day for 2 weeks prior and during the study period
排除标准
- •Pregnancy or currently breastfeeding.
- •History of autoimmune disease or immune disorders.
- •History of asthma.
- •History of allergic rhinitis.
- •History of physician diagnosed eczema, psoriasis or other skin condition that could mask an Echinacea-induced rash.
- •Known allergic reaction to Echinacea or related species, specifically ragweed (Ambrosia), chamomile (Matricaria), goldenrod (Solidago), and sunflower (Helianthus).
- •Known allergic reaction to xylitol sweetener, glycerine, citric acid, or citrus fruits
结局指标
主要结局
Peak Level of TNF Alpha
时间窗: 1-10 days after starting study medication
Highest level of TNF alpha while taking study medication
次要结局
- Peak Level IL-6(1-10 days after starting study medication)
- Peak Level Interferon Gamma(1-10 days after starting study medication)
- Peak Level IL-2(1-10 days after starting study medication)
- Number of Participants With Adverse Events as a Measure of Safety and Tolerability(1- 30 days after starting study medication)
研究者
James Taylor
Professor
University of Washington