Study to Investigate if Sucking a Coldamaris Lozenge Elutes Sufficient Iota-carrageenan to Inactivate Usual Common Cold Viruses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- The primary outcome measure is the iota-carrageenan concentration in saliva.
研究概览
简要总结
Coldamaris lozenges are a medical device containing 10 mg carrageenan/lozenge. The goal of the study is to determine whether the iota-carrageenan content in the saliva of subjects who sucked Coldamaris® lozenges is sufficient to inhibit the replication of 4 of the most common respiratory viruses causing common cold. At least 29 subjects will be screened, in order to get 24 subjects included.
详细描述
Coldamaris lozenges are a medical device containing 10 mg carrageenan/lozenge. The goal of the study is to determine whether the iota-carrageenan content in the saliva of subjects who sucked Coldamaris® lozenges is sufficient to inhibit the replication of 4 of the most common respiratory viruses causing common cold. At least 29 subjects will be screened, in order to get 24 subjects included.
The primary objective is whether the mean iota-carrageenan concentration in saliva during sucking an iota-carrageenan containing lozenge reaches published IC90 values for HRV1a and HRV8.
The secondary objectives are whether the mean iota-carrageenan concentration in saliva (µg/ml; base line corrected) during sucking an iota-carrageenan containing lozenge reaches the respective IC90/MIC values (paired t-tests) of the clinical saliva samples for HRV1a, HRV8, hCoV OC43, influenza virus H1N1n and Coxsackie virus A10.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •personally signed and dated informed consent
- •healthy respiratory tract, no acute infection
- •age > 18 years
排除标准
- •subjects with signs of an acute respiratory infection
- •subjects with a known hypersensitivity to one of the ingredients
- •presence of pregnancy confirmed
结局指标
主要结局
The primary outcome measure is the iota-carrageenan concentration in saliva.
时间窗: 3 months
The mean iota-carrageenan concentration in saliva during sucking an iota-carrageenan containing lozenge should reach published IC90 values for 2 human rhinoviruses.
次要结局
- The secondary outcome measure is the iota-carrageenan concetration in salvia.(3 months)