NCT01418066已完成不适用
Feasibility and Safety of Ayurvedic Herbs in Diarrhoea-predominant 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
- 32
- 试验地点
- 1
- 主要终点
- irritable bowel syndrome- symptom severity score
研究概览
简要总结
In the present study the investigators are trying to evaluate the effect of Murraya koenigii leaves, Punica granatum and Curcuma which is administered to the patients in a combined form as tea. This study will help to evaluate the effect of these preparations scientifically in improving the IBS symptoms.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
Placebo
Placebo Comparator
Tea decoction made of Graminis Flores abd Maidis stigmata.
干预措施: Placebo tea (Drug)
Ayurvedic herbs
Experimental
Tea decoction made of Murraya koenigii leaves, Punica granatum and Curcuma
干预措施: Ayurvedic Herbs (Drug)
结局指标
主要结局
irritable bowel syndrome- symptom severity score
时间窗: T2 (Day 28)
IBS-SSS(Francis, 1997)
次要结局
- Frequency of abdominal discomfort/Pain(last week of treatment (days 21-28))
- Intensity of Abdominal Pain/Discomfort(Last week of treatment (days 21-28))
- Stool and diarrhea Frequency(last week of treatment (days 21-28))
- Quality of life(T2 (Day 28))
- IBS Specific Quality of life(T2 (Day 28))
- Depression and Anxiety(T2 (day 28))
- Adequate Relief Score(at day 7, 14, 21 and 28)
- Global improvement(at days 7, 14, 21 and 28)
- adverse events(up to week 15)
研究者
Jost Langhorst
Prof. Dr.
Universität Duisburg-Essen
研究点 (1)
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