NCT01418053已完成不适用
Randomised Controlled Study on the Effect of a Kneipp Hot Cataplasm With Caraway Oil in the Treatment of Irritable Bowel Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Irritable Bowel Syndrome - Symptom Severity Score
研究概览
简要总结
The purpose of this study is to determine whether a daily use of a Kneipp hot cataplasm with caraway oil is effective in the treatment of abdominal pain and complaints caused by Irritable bowel syndrome.
详细描述
see above.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Irritable Bowel Syndrome according to Rom-III
- •Subtype Diarrhea or Alternating
- •discomfort or pain > 1 times a week
- •discomfort or pain > 4 on a Visual Analog Scale
排除标准
- •Inflammatory bowel diseases (test results necessary)
- •Lactose, Fructose Malabsorption (test results necessary)
- •Celiac Disease
- •Pregnancy or Breastfeeding
- •Colectomy or Hemicolectomy >50cm
- •Severe metabolic disorders, hormonal disorders, cardiac or respiratory failure, liver or renal diseases
- •severe depression, psychotic or psychiatric disorders, substance abuse
- •cancer within the last 5 years
- •allergy to caraway
- •acute inflammatory diseases
研究组 & 干预措施
Hot Cataplasm with Caraway Oil
Experimental
干预措施: caraway oil (Drug)
Hot Cataplasm with Olive oil
Active Comparator
干预措施: Olive oil (Drug)
Cold cataplasm with Olive oil
Active Comparator
干预措施: Olive oil (Drug)
结局指标
主要结局
Irritable Bowel Syndrome - Symptom Severity Score
时间窗: at T2 (Day 21)
IBS-SSS (Francis 1997)
次要结局
- Frequency of abdominal discomfort/Pain(last week of treatment (days 14-21))
- Intensity of abdominal discomfort/Pain(last week of treatment (days 14-21))
- Quality of life(T2 (Day 21))
- Quality of life - ibs specific(T2 (day 21))
- Depression and Anxiety(T2 (day 21))
- Global improvement(At day 7, 14 and 21)
- h-BD2(T2 (day 21))
- Adequate Relief Score(at day 7, 14, 21)
研究者
Jost Langhorst
Prof. Dr. med.
Universität Duisburg-Essen
研究点 (1)
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