Ayurvedic Nutritional Counseling for Patients With IBS in Comparison to Conventional Nutritional Counseling

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Controlled Study on Ayurvedic Nutritional Counseling for Patients With Irritable Bowel Syndrome in Comparison to Conventional Nutritional Counseling

Conditions
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IBS - Irritable Bowel Syndrome

Intervention / Treatment
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* Behavioral: Ayurvedic nutritional counseling
* Behavioral: Conventional nutritional counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ayurvedic nutritional counseling<br>Patients will receive three Ayurvedic nutritional counselings (according to tradition) after 1, 3 and 8 weeks after Baseline. | Behavioral: Ayurvedic nutritional counseling<br> <br> |
| Active Comparator: Conventional nutritional counseling<br>Patients will receive three conventional nutritional counselings (according to German Nutrition Society - DGE) after 1, 3 and 8 weeks after Baseline. | Behavioral: Conventional nutritional counseling<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) - Change |  | Change from IBS-SSS Baseline at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cohen Perceived Stress Scale (CPSS) - Change |  | Change from CPSS 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 | 
| Irritable bowel Syndrome - Quality of life (IBS-QOL) - Change |  | Change from IBS-QOL 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-Severity Scoring System (IBS-SSS) - Change |  | Change from IBS-SSS Baseline at 4 weeks and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ayurveda, IBS, Complementary medicine, nutritional counseling