Bioavailability of an Echinacea Product (Echinaforce® Junior) in Children With a Common Cold, Aged 4-12 Years After Intake of a Daily Dosage
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- A. Vogel AG
- 试验地点
- 1
- 主要终点
- Peak Plasma Concentration (Cmax)
研究概览
简要总结
In this bioavailability trial should be shown that the one of the main active constituent in alcoholic echinacea extracts, the alkylamide dodeca-2E,4E,8Z,10E/Z-tetraenoic acid isobutylamide (short: tetraen) is bioavailable in children of different age groups after intake of 5 Echinaforce junior tablets.
详细描述
In this bioavailability trial should be shown that the one of the main active constituent in alcoholic echinacea extracts, the alkylamide dodeca-2E,4E,8Z,10E/Z-tetraenoic acid isobutylamide (short: tetraen) is bioavailable in children of different age groups after intake of 5 Echinaforce junior tablets.
Six capillary blood draws are taken at the following time points: Start (0), after 15, 30, 60, 90, 270 minutes and thereafter the bioavailability is measured and calculated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children in the age group 4-12 years with an uncomplicated common cold (upper respiratory tract infection)
- •First symptoms appeared within the last 72 hours
- •Written consent given by the parents and verbal consent of children who are capable of judgement
排除标准
- •Not able to fast 2 hours prior to the treatment
- •intake of another preparation containing echinacea within the last 24 hours
- •Participation in a clinical trial within the last 30 days
- •any progressive systemic illness, including tuberculosis, leukemia, connective tissue diseases, multiple sclerosis, or other autoimmune diseases; or
- •history of relevant allergy, including allergy to Compositae plants
研究组 & 干预措施
Echinaforce junior
Echinaforce is an ethanolic extract from Echinacea purpurea fresh plant and root. The product is registered in Switzerland for children from age 4 years on for Treatment and prevention of respiratory tract infections.
干预措施: Echinaforce junior (Drug)
结局指标
主要结局
Peak Plasma Concentration (Cmax)
时间窗: 270 minutes measurement
Peak concentration of tetraen
次要结局
- Area under the plasma concentration versus time curve (AUC)(270 minutes measurement)
- Timepoint when Cmax is reached (tmax)(270 minutes measurement)