NCT00906438已完成1 期
Effects of 2006-RD-05 on Salivary and Serum IgA Levels in Healthy Subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Occurrence of adverse events
研究概览
简要总结
It is already known from animal studies that the study drug can improve mucosal immunity as shown by increased serum and mucosal IgA secretion. This study will evaluate the safety of an oral intake of the natural product 2006-RD-05 at the recommended daily dose of 300 mg. In addition, this trial will aim to determine if this intake is able ot improve serum and salivary IgA synthesis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or women aged 18 - 60
- •In good health
- •BMI between 20 and 30 kg/m2
- •Non-smoking
排除标准
- •Allergic to study drug
- •Use of immune-modulating drugs
- •Uncontrolled hypertension (Systolic > 140 or diastolic > 90)
- •Women of childbearing age not using proper contraception, that is pregnant or breastfeeding
结局指标
主要结局
Occurrence of adverse events
时间窗: Baseline, 14 days, 28 days
次要结局
- Serum IgA titers(Baseline, 14 days, 28 days)
- Salivary IgA titers(Baseline, 14 days, 28 days)
研究者
研究点 (2)
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