NCT01964885终止3 期
Clinical Trial to Explore Benefit and Tolerability of IQP-AS-105 (Xaludicin®) in Subjects With Increased Susceptibility to Upper Respiratory Tract Infections
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Difference in severity of common cold symptoms for cold episodes between the two arms
研究概览
简要总结
IQP-AS-105, is a food supplement derived from garlic (Allium sativum). The objective of this study is to evaluate the possibilities of clinical use of IQP-AS-105 as a preventive medicine, based on its ability to enhance the immune system responses
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 18-70 years
- •increased risk for infections - at least 4 cold episodes within 12 months
- •commitment to adhere to their accustomed diet and physical activity
- •women of child-bearing potential have to agree to use appropriate birth control methods
- •written consent of the subject to participate is a prerequisite for study participation
排除标准
- •acute / chronic upper airways disease
- •chronic cough of any origin
- •acute / chronic lower airways disease
- •any allergic reaction that may influence the study outcome (e.g. acute/chronic rhinitis)
- •history of nasal reconstructive surgery
- •presence of nasal ulcers or nasal polyps
- •severe nasal septum deviation or other condition that could cause nasal obstruction
- •congenital or acquired immunodeficiency disease (e.g. HIV infection)
- •severe organ or systemic diseases
- •body temperature above 37.5°C
- •suspected swine flu or influenza
- •vaccination against influenza or swine flu within 3 months prior to study start
- •stomach/gastrointestinal diseases
- •sleep disorder
- •psychiatric disorders
- •known sensitivity to the ingredients of the investigational product
- •intake of products that may influence the study outcome within the last 14 days prior to study start and during the study
- •analgesics , antibiotics or decongestant nose drops/spray, unless they are used as rescue medications
- •pregnancy or nursing
- •alcohol / drug abuse
- •simultaneous participation in another clinical trial or participation in a clinical trial within the last 30 days
- •insufficient compliance
结局指标
主要结局
Difference in severity of common cold symptoms for cold episodes between the two arms
时间窗: 12 weeks
Assessed by WURSS-21
次要结局
- Incidence of viral infection(12 weeks)
- Day and score value of the maximal WURSS-21 daily score(12 weeks)
- Changes in special laboratory parameters in the subgroup(7 days)
- Incidence of cold episodes(12 weeks)
- Severity of cold symptoms at recurring (subsequent) episodes(12 weeks)
- global evaluation of the benefit by the subjects / investigators(12 weeks)
- Duration of cold episodes(12 weeks)
- Severity of cold symptoms over the first 7 days of the episode(12 weeks)
- Severity of cold symptoms over the first 4 days of the episode(12 weeks)
- Use of rescue medication(12 weeks)
- Number of re-infections(12 weeks)
- Severity of cold episodes during the 4 week follow-up period(12 weeks)
- Changes in cytokine production in the subgroup(7 days)
- Severity of cold somptoms from the date of the maximal WURSS-21 daily score, for 4 days following thereafter(12 weeks)
- Number of days on sick leave related to cold episodes(12 weeks)
- Severity of cold symptoms at first episode(12 weeks)
- Global assessment of tolerability by subjects/investigators(12 weeks)
研究者
研究点 (2)
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