Homeopathic Ear Drops for Children With Otitis Media Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 3
- 主要终点
- Administration of Antibiotics
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 in whom the health care provider has recommended that antibiotics not be immediately administered. A total of 150 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
- •Age 6 months - 11 years old
- •Diagnosed with otitis media by clinician at participating clinic
- •Clinician determines that a "watch and wait" antibiotic prescription treatment plan is optimal management
排除标准
- •Antibiotic treatment during past 7 days
- •Homeopathic treatment within past 30 days
- •History of serious chronic illness (e.g. diabetes, autoimmune disease, cystic fibrosis
- •Perforated tympanic membrane
- •Immediate antibiotic treatment plan decided by examining clinician
研究组 & 干预措施
Homeopathic ear drops
Commercially available homeopathic ear drops
干预措施: Hyland's earache drops (Drug)
结局指标
主要结局
Administration of Antibiotics
时间窗: 15 days
Number of participants who filled antibiotic prescription (or called back for promised antibiotic prescription) after being diagnosed with acute otitis media at index visit.
Severity of Symptoms of Otitis Media
时间窗: 15 days
Ear Treatment Group - 5 scores. Parent rated severity of otitis media symptoms including fever, earache, irritability, feeding and sleeping. Each symptom rated 0, 4 or 7. Total scores range 0 (least symptoms) to 35 most symptom. ETG-5 scores collected 12-15 days after enrollment
次要结局
- Side Effects From Study Remedy(15 days)
研究者
James Taylor
Professor
University of Washington