Aromatherapy for Upper Respiratory Health: A Randomized, Placebo Controlled, Triple-Blind Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- severity of respiratory symptoms
研究概览
简要总结
The purpose of this study is to confirm and quantify the effects of aromatherapy on respiratory health.
详细描述
Participants will inhale the scent from an aroma stick every waking hour for the entire duration of a period of respiratory symptoms or 14 days, whichever is shorter. As it is a randomized, placebo-controlled study, some participants will inhale the scent from an aroma stick containing active essential oils while other participants will inhale from an aroma stick containing no essential oils.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness and demonstrated ability to comply with all study procedures and availability for the duration of the study
- •Gender expression: female
- •Aged 20-65
- •In good general health
- •Exhibiting routine upper respiratory symptoms such as: sneezing, coughing, running nose, headache, general fatigue, or dry or sore throat, etc.
- •Ability to utilize the inhaler and be willing to adhere to the regimen
排除标准
- •Current use of bronchodilators or asthma medications
- •Presence of asthma diagnosis or other severe breathing disorder
- •Pregnant or trying to conceive
- •Known allergic reactions to components of the inhaler, specifically plants in the following families: rutaceae, pinaceae, labiatae, and myrtaceae.
- •Treatment with another investigational drug or other intervention within 30 days
- •Current smoker
- •COVID-19 diagnosis
结局指标
主要结局
severity of respiratory symptoms
时间窗: 14 days
Respiratory symptoms are measured using the Franklin Immune Scale, Respiratory Subdomain, which documents the presence of over 20 symptoms, then rates them by severity. Lower scores mean lesser severity.
duration of respiratory symptoms
时间窗: daily up to 14 days
Respiratory symptoms are measured daily; total number of days with symptoms will be calculated to produce a duration score
次要结局
- sleep scores using the Franklin Health Sleep Scale(14 days)