DRKS00033344招募中不适用
Multicentric, uncontrolled, prospective post market clinical follow up (PMCF) study to assess symptom relief by the class I medical device GeloTonsil® Gurgelgel and its tolerability in patients with acute pharyngitis.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Signed informed consent form and data protection form
- •Patient is aged = 18 years
- •Patients is suffering an acute pharyngitis with throat pain
- •Patient is read, write and speak German.
排除标准
- •-Contraindications for GeloTonsil® (Allergy or hypersensitivity to any of the ingredients, current application of other mouth and throat medicines and the lack of ability to gargle safely)
- •-Pregnancy or breastfeeding
- •-Sore throat persisting longer than 5 days
- •-Centor score = 3 (probability to find group A streptococcal infections (GAS) in throat swab – fever >38°, absent from coughing, swollen anterior cervical lymph nodes, Tonsil exudates; one point for each accordance)
- •-Patients requiring antibiotic treatment for any condition at study entry
- •-Parallel participation in another study, participation in a study within less than 6 weeks prior to study entry, or previous participation in this same study
- •-Employee or direct relative of an employee of the investigational site or of the study sponsor
- •-Known to be, or suspected of being unable to comply with the study protocol (e.g. no permanent address, history of drug abuse, known to be non-compliant or presenting an unstable psychiatric history)
- •-Legal incapacity and / or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the study
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