DRKS00020243已完成不适用
Effectiveness, safety and tolerability of junior-angin N SIRUP (syrup) and junior-angin N Lutschtabletten (lozenges) in children and adolescents with sore throat/hoarseness – a PMCF-study - KAST (Klosterfrau Sore Throat)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 135
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
- 2 Years 至 17 Years（—）
- 性别
- All
入选标准
- •1. Children from 2 years and adolescents up to 17 years old (junior-angin N SIRUP) or
- •2. Children from 4 years and adolescents up to 17 years old (junior-angin N Lutschtabletten), respectively;
- •3. Presence of sore throat/hoarseness as a symptom of an acute infection of the upper respiratory tract or other irritation causing conditions since = 48 hours;
- •4. Satisfactory general health status except for the upper respiratory tract infection according to the assessment of the investigator;
- •5. Written informed consent (for minors also from one/both parent(s));
- •6. Willingness to comply with intake specifications of the medical device, the study procedures and completion of the patient diary;
- •7. Confirmed diagnosis justifying the application of the medical device for the treatment of the complaints.
排除标准
- •1. Children younger than 2 years and adults older than 18 years (junior-angin N SIRUP) or
- •2. Children younger than 4 years and adults older than 18 years (junior-angin N Lutschtabletten), respectively;
- •3. Pregnant or breastfeeding women;
- •4. Known allergy/hypersensitivity against one of the ingredients;
- •5. Presence of a contraindication as listed in the instructions for use;
- •6. Presence of any sign for a bacterial infection requiring treatment with systemic antibiotics;
- •7. Any painful disorder that can distract attention from sore throat (e.g. mouth ulcers) or that requires application of analgesics;
- •8. Surgical interventions in the mouth and throat before inclusion in the study;
- •9. Parallel participation or planned parallel participation in clinical investigation or observational studies;
- •10. Earlier participation in this PMCF-study.
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