DRKS00016976已完成未知
Comparative study on mucoadhesive changing effects on saliva by sucking a new polysaccharide containing formulation after single dosing in patients with oro-pharyngeal symptoms - P341
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Age: >18 years
- •Male or female
- •Redness and/or swelling of the pharyngeal cavity diag-nosed by the investigator
- •Assessment of the symptom sore throat with the intensity of = 40 mm on a visual analogue scale from 0 to 100 mm
- •Assessment of at least 1 further symptom (difficulty swallowing, hoarseness, tickly throat, dry mouth) with the intensity of = 40 mm on a visual analogue scale from 0 to 100 mm
- •Written informed consent
排除标准
- •Pregnant or nursing women
- •Visit to the doctor due to the oro-pharyngeal symptoms
- •Oro-pharyngeal symptoms for more than 2 days
- •Fever (= 38,5°C) on the day of clinical trial participation
- •Intake of medication and/or medical devices for the treat-ment of oro-pharyngeal symptoms the day before and on the day of clinical trial participation
- •Intake of analgesics 24 hours before and on the day of clinical trial participation
- •Hypersensitivity against one of the ingredients
- •Pathological reduction in Salivation
- •Pre-existing chewing and swallowing disorder
- •Participation in a clinical investigation within the past 4 weeks
- •Patient who are known or suspected
- •o not to comply with the clinical trial directives.
- •o not to be reliable or trustworthy.
- •o not to be capable of understanding and evaluating the information given to them as part of the formal information policy (informed consent), in particular regarding the risks and discomfort to which they would agree to be exposed.
研究者
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