NCT01106703已完成2 期
The Effects of PG102 on Allergy-related Risk Factors: A Randomized, Double Blind, Placebo Controlled Study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- serum total IgE level
研究概览
简要总结
The aim of this study was to evaluate the efficacy of PG102 at lowering levels of total IgE in asymptomatic subjects with atopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •subjects who have atopy but no allergy-related symptoms
- •subjects with total IgE levels of 300IU/ml or more
- •acquisition of written informed consent prior to commencement of study
- •no serious clinical symptoms and normal laboratory test results; in case of abnormal finding, subjects whose conditions are not deemed severe from the judgement of investigators
排除标准
- •individuals with normal levels of total serum IgE
- •ue of one or more allergic drugs
- •serious clinical conditions (such as malignancies, severe cardiovascular disease etc.)
- •serious mental disorder
- •pregnant woman or woman of childbearing potential within 3 months
- •subjects who participated in other clinical trials in the past 6months
- •individuals who have a plan to participate in another clinical trials during this trial
- •subjects with a history of kiwi allergy
- •subjects whose conditions are inappropriate by investigators
结局指标
主要结局
serum total IgE level
时间窗: 8weeks
次要结局
- serum level of allergy-related factors, such as eosinophilic cation protein(ECP), eotaxin, thymus, and activation-regulated chemokine (TARC), IL-4, IL-5, and IL-13, skin test(atopy score), and adverse reactions(8weeks)
研究者
研究点 (2)
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