Randomized Controlled Trial of a Homeopathic Cold Remedy for Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 263
- 试验地点
- 1
- 主要终点
- Change in Severity of Cold Symptoms
研究概览
简要总结
A randomized controlled trial of a commercially available homeopathic cold remedy will be conducted. A total of 400 children, 2-5 years old, diagnosed with an upper respiratory tract infection will be randomized to receive either the homeopathic remedy or placebo. Parents of study children will administer 5 ml of the study medication up to 6 times per day as needed to treat cold symptoms. One hour after giving a dose the parent will rate change in symptoms (for up to the first 10 doses). In addition, parents will rate their child's overall symptom severity and functional status over the first 3 days of the cold. It is postulated that children receiving the active homeopathic remedy will have better symptom relief and that their symptom severity and functional status will improve more rapidly than those receiving placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of upper respiratory tract infection
- •duration of symptoms < 7 days
- •Parent who speaks English
排除标准
- •history of asthma
- •on any prescribed medication
- •prescribed any medication other than acetaminophen or ibuprofen at index visit
- •use of homeopathic remedy within 48 hours of index visit
研究组 & 干预措施
Homeopathic cold remedy
5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms
干预措施: Hyland's Cold 'n Cough 4 kids (Drug)
placebo
5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms
干预措施: placebo (Drug)
结局指标
主要结局
Change in Severity of Cold Symptoms
时间窗: Parents assessed change in symptom 1 hour after a dose of study medication
Parents measured change in runny nose, cough, nasal congestion and sneezing severity one hour after administering a dose of study medication up to the first 10 doses of study medication. Change in symptom rated from 0 to 6, with 0 indicative of the symptom being much worse and 6 indicative of the symptom being much improved. The unit of analysis for each outcome was doses of medication. Each participant could contribute data on 0 - 10 doses.
次要结局
- Change in Non-specific Symptoms(Parents assessed change in symptom 1 hour after dose of study medication)
- Functional Status(10 days)
- Health Status(10 days)
- Overall Symptom Severity(10 days)
研究者
James Taylor
Professor
University of Washington