Non Interventional Clinical Investigation of Ectoin® Lozenges in the Treatment of Acute Viral Pharyngitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bitop AG
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- Change in Pharyngitis symptom score evaluated by the physician
研究概览
简要总结
This a comparative, open label, parallel group, non interventional study which compares the tolerability and influence of Ectoin containing Lozenges to saline solution and lozenges containing hyaluronic acid for the treatment of acute viral Pharyngitis. The observation takes place over a period of 7 days. Response to treatment is recorded at day 1 and day 7 by the physician and by the patient in a dairy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with acute Pharyngitis according to instruction for use
- •Female or male individuals ≥ 18 years
- •Agreement to abide by the routinely provided doctor's appointment for follow- up (reflected in the planned visits of observation plan resist)
排除标准
- •Contraindications according to instructions for use
- •Male or female person under 18 years
- •Sore throat for more than 5 days
- •Any disease that can, in the opinion of the treating physician to affect the outcome of the study.
- •Patients with known intolerance to one of the substances used
- •Surgical procedures to the mouth and throat in the last 6 weeks before inclusion in the NIS
- •Bacterial Pharyngitis
- •Pregnancy
结局指标
主要结局
Change in Pharyngitis symptom score evaluated by the physician
时间窗: day 1 and day 7
The intensity of the symptoms and signs will be graded on a continuous numeric scale, i.e. absent-0, severe-10. The following signs and symptoms will be documented: * pain on swallowing * tickle in the throat * hoarseness * dry mouth and throat * burning of throat * patient´s General condition * reddening of the oropharynx * reddening of the larynx
次要结局
- Patient´s Evaluation of tolerability(7 days)
- Change in number and type of adverse Events(7 days)
- Change in Pharyngitis symptoms evaluated on patient´s diaries(7 days)
- physician´s Evaluation of tolerability(day 7)
- Change in patient´s General condition evaluated by the physician(day 1 and day 7)