NCT01684137Unknown不适用
Monitoring of Allergic and Asthmatic Symptoms in Patients Taking Dietary Supplements Joalis Bambi Bronchi and Joalis Bambi Analerg
DSC Services, s.r.o.2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2012年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Reduction of the total IgE (IU/ml) antibody.
研究概览
简要总结
Reduction of the total IgE antibody, improved vital capacity and lung volume measured by spirometry.
Improving quality of life observed in the visual analogue scale (VAS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 9 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subjects with confirmed Asthma bronchiale I-III. degrees in possible combination with other allergic symptoms treating with classic pharmacological treatment
- •9-18 years
- •signed Infromed Conset
排除标准
- •subjects who have previously used a food suplemts Joalis
- •subjects with known intolerance or hypersensitivity to the components of food supplements
- •subjects with alcohol abuse or drugs at the time of recruitment into the study
- •subjects enrolled in another clinical trial in the last 1 month before enrollment in this study
- •subjects in a situation which in the opinion of a doctor may interfere with optimal participation in the study or can pose a risk to the subjects
- •pregnant girls, lactating girls and girls of childbearing age without adequate contraception
结局指标
主要结局
Reduction of the total IgE (IU/ml) antibody.
时间窗: 1 year
Improving of vital capacity measured by spirometry (litre).
时间窗: 1 year
Improving of lung volume measured by spirometry (litre).
时间窗: 1 year
次要结局
- Improving of quality of life observed in the visual analogue scale (VAS).(1 year)
研究者
研究点 (2)
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