Efficacy and Safety of a New Medical Device Based on Resveratrol and Carbossimetyl Beta Glucan in Treatment of Upper Airways Disease in Infancy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Canadian Acute Respiratory Illness and Flu Scale (CARIFS)
研究概览
简要总结
outpatient infants (0-6 months of life), affected by symptoms of upper airways disease will be randomly assigned to two type of intervention:
A: treatment group, receiving resveratrol and carbossimetyl beta glucan; B: control group, receiving saline solution.
Each subject underwent clinical history, objective examination and detection of rinovirus in the nasal secretions at enrollment, after 48 hours and after 7 and 30 days.
详细描述
Consecutive outpatient infants (0 - 6 months) with common cold symptoms were enrolled and randomly divided into two groups: resveratrol plus carboxymethyl-β-glucan solution or saline isotonic solution randomized treatment (3 drops in each nasal fossa, 4 time daily for seven days).
Each patient underwent clinical evaluation at enrollment, after 48 hours and after 7 and 30 days.
Common cold symptoms were specifically evaluated according to CARIFS Scale. Nasal swabs for HRV research will performed at enrollment, after 48 hours and after 7 and 30 days.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •common cold syndrome
排除标准
- •main comorbidities
研究组 & 干预措施
Resveratrol and Carbossimetyl Beta Glucan
干预措施: Resveratrol and Carbossimetyl Beta Glucan (Drug)
Saline solution
干预措施: Saline Solution (Other)
结局指标
主要结局
Canadian Acute Respiratory Illness and Flu Scale (CARIFS)
时间窗: enrollment, after 48 hours and after 7 and 30 days
The CARIFS score consisted of 18 items each answered on a 4-point scale (no problem = 0, minor problem = 1, moderate problem = 2, major problem = 3). Some CARIFS items such as "headache", "sore-throat", "muscle aches or pains" were not applicable to infants. The mean of the point of all applicable items was considered as a measure of child's overall illness level.
次要结局
- Detection of Rinovirus in the nasal secretions(after 48 hours and 7 days)
- 30-day relapses(30-day after treatment)
研究者
Prof. Maria Elisabetta Baldassarre
Researcher
Policlinico Hospital