Evaluation of the Beneficial Effects of a Nasal Spray of Resveratrol in Children With Seasonal Allergic Rhinitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Nasal symptom severity
研究概览
简要总结
The aim of this study is to evaluate whether treatment with a nasal spray based on resveratrol has some benefit in patients with seasonal allergic rhinitis, mild, moderate, or severe.
详细描述
The aim of this study is to evaluate whether treatment with a nasal spray based on resveratrol has some benefit in patients with seasonal allergic rhinitis, mild, moderate, or severe. The primary objective is to assess whether the treatment with nasal spray based resveratrol is able to improve the allergic rhinitis symptoms during the two months of treatment. The secondary aim is to evaluate if the resveratrol nasal spray is able to reduce respiratory infections and wheezing episodes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 4 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children of both sexes, ranging in age from 4 to 17 years
- •History of seasonal allergic rhinitis, mild, moderate or severe, defined according to the ARIA guidelines in 2010, documented by recurrent episodes in the previous year and confirmed by a positive skin test results
- •Written informed consent from at least one parent or a legal representative
排除标准
- •Lack of informed consent in writing by at least one parent or a legal representative
- •Concomitant disorders, such as infection of the upper (sinusitis, etc..) or lower respiratory tract, nasal surgery in the last year, abnormalities of the respiratory tract, immune diseases
- •Use of antihistamines, nasal or systemic corticosteroids, leukotriene modifiers, cromolyn sodium, in the last six weeks
研究组 & 干预措施
Resveratrol nasal spray
2 sprays per nostril 3 times a day for a period of two months
干预措施: Resveratrol nasal spray (Drug)
Placebo
2 sprays per nostril 3 times a day for a period of two months
干预措施: Resveratrol nasal spray (Drug)
结局指标
主要结局
Nasal symptom severity
时间窗: two years
Nasal symptoms (itching, sneezing, rhinorrhea, and obstruction) will be scored by a four-point scale (0=no symptom; 1=mild; 2= moderate; 3= severe) and record by parents on a daily diary card.
次要结局
- Cough(two years)
- Wheezing(two year)
- Albuterol use(two years)
- Fever(two years)
- School absences(two years)
- Antihistamines use(two years)
- Emergency visits(two years)
研究者
Prof. Michele Miraglia del Giudice
Prof. Michele Miraglia del Giudice
University of Campania "Luigi Vanvitelli"