Echinacea Purpurea and Cranial Osteopathic Manipulative Treatment in Children With Recurrent Otitis Media: a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 3
- 主要终点
- The occurrence of a first episode of acute otitis media during the study period.
研究概览
简要总结
This study was designed to evaluate the efficacy of the herb Echinacea purpurea and of cranial osteopathic manipulative treatment to prevent otitis media (middle ear infections) in young children.
详细描述
The use of complementary and alternative therapies by parents of young children remains common despite the lack of clinical trials demonstrating either the efficacy or safety of these treatments. Two of the more common complementary therapies used in young children with a history of recurrent otitis media are preparations of the herb Echinacea purpurea and cranial osteopathic manipulative treatment. This study represents one of the first double-blinded, placebo controlled trials of each approach in a population of young children who presented with three or more recent episodes of acute otitis media.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Months 至 60 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •3 or more separate episodes of acute otitis media within a 6 month period, or
- •4 episodes of acute otitis media in one year,
排除标准
- •Congenital malformations of the ears, nose, or throat
- •Known or suspected allergy to echinacea
- •Immune deficiency including HIV infection
- •Tuberculosis
- •Current use of prophylactic antibiotics
- •Tympanostomy tubes in place
- •Unwillingness of child to participate
研究组 & 干预措施
1
Osteopathic sham treatment plus placebo "Echinacea" drops
干预措施: Sham osteopathic manipulative treatment (Procedure)
1
Osteopathic sham treatment plus placebo "Echinacea" drops
干预措施: "Echinacea purpurea" placebo (Dietary Supplement)
2
Active Echinacea drops plus sham osteopathic treatment
干预措施: Sham osteopathic manipulative treatment (Procedure)
3
Active osteopathic manipulation plus placebo "Echinacea" drops
干预措施: Cranial osteopathic manipulative treatment. (Procedure)
3
Active osteopathic manipulation plus placebo "Echinacea" drops
干预措施: "Echinacea purpurea" placebo (Dietary Supplement)
4
Active osteopathic manipulation plus active Echinacea drops.
干预措施: Cranial osteopathic manipulative treatment. (Procedure)
2
Active Echinacea drops plus sham osteopathic treatment
干预措施: Echinacea purpurea (Dietary Supplement)
4
Active osteopathic manipulation plus active Echinacea drops.
干预措施: Echinacea purpurea (Dietary Supplement)
结局指标
主要结局
The occurrence of a first episode of acute otitis media during the study period.
时间窗: Six months
次要结局
- The total number of episodes of diagnosed acute otitis media during the study period.(Six months)