Ear Drops for Children With Otitis Media
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 1
- 主要终点
- Resolution of Otitis Media Symptoms
研究概览
简要总结
The purpose of this study is to determine if a commercially available homeopathic ear drop preparation is effective in reducing symptoms in children 6 months - 11 years old with acute otitis media. A total of 120 study patients with otitis media will be randomized to receive homeopathic ear drops, or no ear drops, in addition to receiving standard care. It is postulated that children using the ear drops will have more rapid resolution of symptoms and need fewer antibiotics than those randomized to not receive the ear drops.
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
- None
入排标准
- 年龄范围
- 6 Months 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presenting to participating clinic with otitis media
- •Diagnosed with acute otitis media
- •Parents rate symptoms as a "moderate problem" or more
排除标准
- •Diagnosis of otitis media within preceding 30 days
- •Receipt of antibiotics within 2 days
- •Perforated ear drum or bullous lesion
- •Receipt of homeopathic treatment within 30 days
研究组 & 干预措施
1
homeopathic ear drops in addition to standard care for otitis media
干预措施: Hyland's earache drops (Drug)
结局指标
主要结局
Resolution of Otitis Media Symptoms
时间窗: 5 days
Mean scores as measured on the Ear Treatment Group-5 scale. This scale quantifies severity of symptoms in children with otitis media. There are 5 components to the scale: fever, earache or tugging, feeding, irritability and sleep. For each component symptoms are rated as 0, 4 or 7 based on severity, with higher scores indicating more sever symptoms. For the primary outcome, the scores for each component were summed to determine an overall Ear Treatment Group -5 Scale score. Total scores range from 0-35. Two assessessments were conducted each day.
次要结局
- Side Effects of Therapy(5 days)