Acupuncture in Infantile Colic - a Randomised Controlled Double Blind Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- If the rate of infants who still fulfil the colic criterion in each of the intervention weeks differ between groups.
研究概览
简要总结
The purpose of this study is to investigate whether acupuncture influences:
- the rate of infants who still fulfil the colic criterion after three intervention weeks
- the time when the infants are crying, fussing or have intense bouts of colicky symptoms
详细描述
Infantile colic is a common problem. Both the baby and the parents are suffering and there is a risk that the early relationship is disturbed. There is no known treatment that is both effective and harmless. Acupuncture releases different neurotransmitters and hormones, gives pain reduction and affects digestion. Acupuncture in infantile colic has not been studied in a scientific way even though the method is used in many countries. In this randomised study we will investigate if acupuncture affects symptoms in infantile colic.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 2 Weeks 至 8 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •2-8 weeks old otherwise healthy infants who are fussing/crying more than three hours/day, more than three days during one week
排除标准
- •infants born before week 36
- •infants who dont gain weight properly
- •infants taking other medicine than dimethicone or lactobacillus reuteri
结局指标
主要结局
If the rate of infants who still fulfil the colic criterion in each of the intervention weeks differ between groups.
时间窗: First, second and third intervention weeks
次要结局
- If the time when infants are crying, fussing or have intense bouts of colicky symptoms in each of the intervention weeks differ between groups.(First, second and third intervention weeks)