The Effect of Honey on Nocturnal Cough and Sleep Quality: a Double-blind, Randomized,Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- The principal outcome measure of interest was the change in the frequency of cough between the 2 nights (before treatment and tthe night with treatment).
研究概览
简要总结
Cough is a common symptom in pediatric practice. It can be particularly troubling to children and their parents.It often results in discomfort to the child and loss of sleep to both the child and the parent. The objective of this trial was to compare the effects on nocturnal cough and the sleep difficulty associated with URIs of a single nocturnal dose of three different honey products compared to placebo
详细描述
Cough is a common symptom in pediatric practice.As a result, children miss daycare or school and parents miss a day of work. In an attempt to threat cough, caregivers frequently administer OTC medication to their children,with their attendant risks, kack of proven efficacy and the disapproval of professional organizations such as the AAP and the FDA. The WHO has noted honey as a potential treatment for cough and cold symptoms. Honey has antioxidant properties and increases cytokine release. The objective of this trial was to compare the effects on nocturnal cough and the sleep difficulty associated with URIs of a single nocturnal dose of three different honey products compared to placebo
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Year 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1-5 years of age complying of nocturnal cough that was attributed to a URI.
排除标准
- •pneumonia,
- •laryngotracheobronchitis,
- •sinusitis,
- •allergic rhinitis,
- •use of cough or cold medication on the night before entering the study.
结局指标
主要结局
The principal outcome measure of interest was the change in the frequency of cough between the 2 nights (before treatment and tthe night with treatment).
时间窗: changes between two nights ( the night before treatment and the night with treatment)
Pre intervention study questionnaire: The parents were asked to complete a five item questionnaire regarding parental subjective assessments of the child's cough and sleep difficulty on the previous night.Survey responses were graded on a seven point scale ranging from extremely (6 points) to not at all (0 points). On the day following the treatment,the parent completed the same questionnaire that had been answered before the intervention, this time regarding the previous evening when the child had received the treatment.
次要结局
- changes in the cough severity, the bothersome nature of the cough, the effect of the cough on sleep for both the child and parents between the two nights(changes between two nights ( the night before treatment and the night with treatment))