NCT03019861已完成不适用
Randomized Controlled Study on Ayurvedic Nutritional Counseling for Patients With Irritable Bowel Syndrome in Comparison to Conventional Nutritional Counseling
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 4
- 主要终点
- Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) - Change
研究概览
简要总结
The main goal of this randomized controlled clinical study is to evaluate the efficacy of an individual Ayurvedic nutritional counseling (according to tradition) compared to an individual conventional dietary advice (according to the German Nutrition Society - DGE) in patients with irritable bowel syndrome. It is to be investigated whether nutritional therapy elements, which patients can self-implement independently in the home environment, can achieve sustainable therapy effects.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis "irritable bowel syndrome" according to the ROM-III criteria and the German S3 guideline (Layer 2011)
- •Female and male patients between 18 and 70 years of age
- •Declaration of consent
排除标准
- •Bad general condition
- •Serious acute or chronic comorbidity
- •Pregnancy and breast feeding period
- •Eating disorder
- •In recognition procedures for early retirement or disability
- •Simultaneous participation in another clinical trial
- •Participation in a clinical trial within the last 3 months before enrollment
结局指标
主要结局
Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) - Change
时间窗: Change from IBS-SSS Baseline at 12 weeks
次要结局
- Cohen Perceived Stress Scale (CPSS) - Change(Change from CPSS Baseline at 4 weeks, 12 weeks and 6 months)
- Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) - Change(Change from IBS-SSS Baseline at 4 weeks and 6 months)
- Irritable bowel Syndrome - Quality of life (IBS-QOL) - Change(Change from IBS-QOL Baseline at 4 weeks, 12 weeks and 6 months)
- Hospital Anxiety and Depression Scale (HADS-D) - Change(Change from HADS-D Baseline at 4 weeks, 12 weeks and 6 months)
- VAS: Pain, Sleep, General bothersomeness, Expectation - Change(Change from VAS Baseline at 4 weeks, 12 weeks and 6 months)
研究者
Andreas Michalsen
Principal Investigator
Charite University, Berlin, Germany
研究点 (4)
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