Ayurvedic Nutritional Counseling for Patients With IBS in Comparison to Conventional Nutritional Counseling
Not Applicable
Completed
- Conditions
- IBS - Irritable Bowel Syndrome
- Registration Number
- NCT03019861
- Lead Sponsor
- Charite University, Berlin, Germany
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 69
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) - Change Change from IBS-SSS Baseline at 12 weeks
- Secondary Outcome Measures
Name Time Method 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 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 Irritable bowel Syndrome - Quality of life (IBS-QOL) - Change Change from IBS-QOL Baseline at 4 weeks, 12 weeks and 6 months
Trial Locations
- Locations (2)
Kliniken Essen-Mitte
🇩🇪Essen, Am Deimelsberg 34 A, Germany
Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus
🇩🇪Berlin, Germany
Kliniken Essen-Mitte🇩🇪Essen, Am Deimelsberg 34 A, Germany