Non-interventional Study to Investigate the Application of Ectoin Containing Lozenges (EHT02) in Patients With 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
- 102
- 试验地点
- 1
- 主要终点
- Change in Pharyngitis symptom score evaluated by the physician
研究概览
简要总结
The goal of this non-interventional study is to investigate the safety, efficacy and tolerability of Ectoin Lozenges Honey Lemon (EHT02) compared to lozenges containing hyaluronic acid and islandic moss in the treatment of acute viral pharyngitis.
详细描述
The current non-interventional study aims to investigate the efficacy and tolerability of Ectoin Lozenges Honey Lemon in patients suffering from acute viral pharyngitis. Participants receive treatments as part of routine medical care, and participants can choose one of two treatment options: a) Ectoin Lozenges Honey Lemon or b) lozenges containing hyaluronic acid and icelandic moss.
Efficacy will be studied by documentation of the following symptoms:
- pain on swallowing
- hoarseness
- urge to cough
- dry mouth and throat
- redness of oropharynx and larynx
- sore throat
- impairment of free breathing
- general feeling of illness
In parallel, participating patients will document their symptoms over the entire study duration in patient diaries.
The observation takes place over a period of seven days.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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 viral pharyngitis
排除标准
- •patients with known intolerance to one of the substances used
- •Pregnancy
- •Surgical Procedures in the mouth and throat region prior to the study
- •Bacterial Pharyngitis
- •symptoms in the throat since more than 5 days
- •Contraindications according to the instructions for use
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 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 * hoarseness * urge to cough * dry mouth and throat * reddening of oropharynx * reddening of larynx * sore throat * impairment of free breathing * patient's general condition
次要结局
- Evaluation how efficient the treatment is judged by physician(day 7)
- Change of Saliva production evaluated by the physician(day 7)
- Evaluation how treatment is tolerated (judged by patients)(7 days)
- Evaluation of compliance evaluated by physician(day 7)
- Change in Pharyngitis Symptoms evaluated in patient's diaries(7 days)
- Evaluation how treatment is tolerated (judged by physician)(day 7)
- Incidence of adverse events/serious adverse events(7 days)
- Evaluation how efficient the treatment is judged by patient(7 days)