Integrative Therapy in Gastroenterology - a Prospective Observational Trial in a Department of Internal and Integrative Medicine
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Symptoms Severity CAI
研究概览
简要总结
This study aims to test, if a two-week integrative therapy in an internal medicine ward will improve symptoms, disability and quality of life in patients with inflammatory bowel disease or irritable bowel syndrome.a It shall further be tested, if those changes are associated with attitudes and experiences towards complementary and alternative medicine, anxiety, depression and stress perception as well as body awareness and responsiveness.
详细描述
see above
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •18 years or older
- •diagnosed with Irritable Bowel Syndrome (IBS) or Inflammatory Bowel Disease (IBD)
- •written informed consent
排除标准
- •participation in other clinical studies
结局指标
主要结局
Symptoms Severity CAI
时间窗: 2 weeks
Symptoms Severity assessed by Clinical Activity Index (CAI) (Rachmilewitz 1989)
Symptoms Severity CDAI
时间窗: 2 weeks
Symptoms Severity assessed by Crohn Disease Activity Index (CDAI)
Symptoms Severity IBS-SSS
时间窗: 2 weeks
Symptoms Severity assessed by Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) (Francis, 1997)
次要结局
- Disability MYMOP(24 weeks)
- Symptoms Severity CDAI(24 weeks)
- Quality of Life IBS-QOL(24 weeks)
- Body awareness BAQ(24 weeks)
- Body awareness BRS(24 weeks)
- Symptoms Severity IBS-SSS(24 weeks)
- Adverse effects(2 weeks)
- Symptoms Severity CAI(24 weeks)
- Quality of Life IBDQ(24 weeks)
- Self efficacy questionnaire SWE(24 weeks)
研究者
Romy Lauche
Principal Investigator
Universität Duisburg-Essen