Integrative Therapy in Gastroenterology - a Prospective Observational Trial in a Department of Internal and Integrative Medicine
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Crohns Disease
- Sponsor
- Universität Duisburg-Essen
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Symptoms Severity CAI
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Detailed Description
see above
Investigators
Romy Lauche
Principal Investigator
Universität Duisburg-Essen
Eligibility Criteria
Inclusion Criteria
- •18 years or older
- •diagnosed with Irritable Bowel Syndrome (IBS) or Inflammatory Bowel Disease (IBD)
- •written informed consent
Exclusion Criteria
- •participation in other clinical studies
Outcomes
Primary Outcomes
Symptoms Severity CAI
Time Frame: 2 weeks
Symptoms Severity assessed by Clinical Activity Index (CAI) (Rachmilewitz 1989)
Symptoms Severity CDAI
Time Frame: 2 weeks
Symptoms Severity assessed by Crohn Disease Activity Index (CDAI)
Symptoms Severity IBS-SSS
Time Frame: 2 weeks
Symptoms Severity assessed by Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) (Francis, 1997)
Secondary Outcomes
- 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)