Clinical Evaluation of the Efficacy of Two Nasal Products for Decongestion and Mucus Fluidification
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- YSLab
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Effect of nasal washing with a hypertonic seawater solution Nose hygiene).
研究概览
简要总结
The main objective is to compare the effect of nasal washing on nasal discharge and nasal congestion during treatment after 3 days of use.
详细描述
The main endpoint is a symptom score derived from the Jackson scale: sum of 2 items relating to runny nose and nasal congestion (stuffy nose), with ratings of 0 to 3 for each (0: absent ; 1: mild; 2: moderate; 3: severe).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Person with an upper respiratory condition (cold, rhinitis, nasopharyngitis ...) with symptoms of nasal congestion and intense runny nose moderate to severe (Jackson derived score ≥ 4)
- •Ability of the patient (for adults) or their legal representative (for children) to follow the guidelines of the medical device
- •have given their written informed consent
排除标准
- •Patient with no cold symptoms, including no nasal congestion (chronic dry rhinitis…)
- •Patient under treatment with cortisone derivative, mucolytic, or medication containing pseudoephedrine or related product acting on nasal congestion or having used such a product in the 3 days before inclusion
- •Patient who used a nasal wash product in the 3 days before inclusion
- •Patient allergic to seafood, or to any of the components of the products under study
- •Vulnerable patient whose inclusion is not justified by the research objectives: woman pregnant, parturient, psychiatric patient, or adult subject to legal protection
- •Patient participating or having participated in any other clinical study in the 30 days before the study.
结局指标
主要结局
Effect of nasal washing with a hypertonic seawater solution Nose hygiene).
时间窗: 3 days
Effect of nasal washing with a hypertonic seawater solution (Ocean Bio Actif-Fluid + or Ocean Bio Actif-Stuffy nose) on runny nose and nasal congestion during treatment after 3 days of use, compared to an isotonic solution (Ocean Bio Actif- Nose hygiene). symptom score (runny nose and nasal congestion) derived from the Jackson scale with a score of 0 to 3 for each (0: absent; 1: mild; 2: moderate; 3: severe) between Day 0 and Day 3.
次要结局
- Likert scale(7 days)
- Symptom score(7 days)
- Number of concomitant treatment(7 days)
- Safety of medical device(7 days)
- Presence or absence of fluid mucus(7 days)
- Global Clinical Impression Scale(between day 3 and day 7)
- Global Patient Impression Scale(between day 3 and day 7)
- Use of medical device(7 days)