Evaluation of the Efficiency of Nasal Spray Hypertonic Puressentiel on Symptoms of Patients With Allergic Rhinitis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Rhinitis auto questionnaire symptoms
研究概览
简要总结
Prospective multicentric study.
60 subjects with allergic rhinitis will be enrolled to test the efficacy of nasal hypertonic spray Puressentiel on symptoms of allergic rhinitis and nasal peak flow.
Subjects with allergic rhinitis and nasal obstruction will use during 30 days the nasal spray (2 nebulisations /day in each nostril) during 30 days.
Rhinitis symptoms questionnaire and nasal inspiratory peak flow will be evaluated before and after 30 days of exposure.
详细描述
Objective
evaluate the efficiency of a nasal hypertonic spray Puressentiel in subjects with allergic rhinitis and nasal obstruction.
Inclusion criteria: subjects with allergic obstructive rhinitis without treatment or remaining symptomatic despite treatment.
Duration of exposure: 2 nasal sprays per day (morning and evening) during 30 months.
Primary criteria of efficacy: Rhinitis questionnaire.
Secondary criteria: Inspiratory nasal peak flow
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •allergic rhinitis with nasal obstruction
排除标准
- •pregnant patients
- •patients with severe asthma
研究组 & 干预措施
allergic rhinitis
administration of a nasal hypertonic spray twice a day for one month
干预措施: nasal hypertonic spray: combination of hypertonic sea water and organic rosemary floral water with essential oils (ravintsara, geranium, eucalyptus radiata, niaouli) (Other)
结局指标
主要结局
Rhinitis auto questionnaire symptoms
时间窗: Measurement at Day 30
5 questions quoted from 1 (worse) to 5 (best).
次要结局
- Nasal inspiratory peak flow(Measurement at Day 30)