Treatment of Acute Rhino-Sinusitis With Essential Oils of Some Aromatic Medical Plants.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- To demonstrate a relief in the nasal obstruction within the first 20 minutes after first administration of treatment with the spray.
研究概览
简要总结
This randomized, double blind, parallel group study, compared the efficacy of spray containing aromatic essential oils of some herbal plants, against placebo in the treatment of patients with acute Rhino-sinusitis.
Study objectives: Primary to demonstrate a relief in the nasal obstruction within 20 minutes after first administration of treatment with the spray.
Secondary to demonstrate a reduction of a defined symptoms sum score based on symptoms and signs comparing baseline therapy from the beginning to the end of 3 days treatment
详细描述
This study compared the efficacy of spray containing aromatic essential oils of Eucalyptus citriodora, Eucalyptus globulus, Mentha piperita, Origanum syriacum, and Rosmarinus Officinalis, against placebo in the treatment of patients with acute Rhino-sinusitis.
In- vitro and clinical studies suggest therapeutic potential of aromatic herbs and trees oils in the treatment of Rhino-sinusitis. The pharmacological and clinical activity of Eucalyptus citriodora, Eucalyptus globulus, Mentha piperita, Origanum syriacum, and Rosmarinus Officinalis, include anti-inflammatory, anti-bacterial and anti-viral activities. Some of these herbs and trees oils have direct activity on the respiratory tract, the coughing reflex and the airflow in the nasal tract.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of acute Rhino-sinusitis.
- •Active disease less than 96 hours
- •Patients agree to sign informed consent according to GCP and Israel national regulations.
排除标准
- •Acute Sinusitis that need to get an antibiotically treatment .
- •Nasal polyposis.
- •Under any antibiotically treatment.
- •Asthma disease.
- •Under coumadine therapy.
- •Hyper sensitivity to Aromatic essential oils.
- •Any immuno-suppressive disease
结局指标
主要结局
To demonstrate a relief in the nasal obstruction within the first 20 minutes after first administration of treatment with the spray.
时间窗: 20 minutes
次要结局
- To demonstrate a reduction of a defined symptoms sum score based on symptoms and signs comparing baseline therapy from the beginning to the end of 3 days treatment.(3 days)