Efficacy of Homeopathy Intervention in Managing Upper Respiratory Infections in Infants and Children - A Double-blind RCT
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Response rate: percentage of patients with complete recovery or major improvement after 14 days
研究概览
简要总结
The aim of this study was to assess the effectiveness of homeopathy compared to conventional treatment in acute respiratory infections/complaints in a primary care setting in infants and children. We aim to recruit 300 children, 150 in each arm, and follow a randomized controlled double blind active controlled design, with one arm receiving homeopathy treatment and other arm receiving conventional treatment. The primary outcome variable is response rate and recovery at 14 days. We also aim at assessing time to onset of first improvement, sleep quality, adverse events, patient satisfaction and number of hospital consultations and hospitalization on follow-up at 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 2.00 Day(s) 至 13.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients older than one day, presenting themselves with at least one of five chief complaints (runny nose, sore throat, fever, ear pain, sinus pain or cough), and onset of symptoms not more than 7 days before, were eligible to participate.
排除标准
- •Exclusion criteria were among others severe mental impairment, severe chronic diseases such as severe cardiac or respiratory disorders, malignancy, spinal cord injuries or drug abuse.
结局指标
主要结局
Response rate: percentage of patients with complete recovery or major improvement after 14 days
时间窗: day 0, day 7, day 14, day 28 and follow-up at 6 months
次要结局
- time to onset of first improvement, patient satisfaction, sleep quality, adverse events, number of hospital consultations required in next 6 months.(day 0, day 7, day 14, day 28 and follow-up at 6 months)