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

N/ACompletedNCT03019861

Charite University, Berlin, Germany69 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

IBS - Irritable Bowel Syndrome

Interventions

Ayurvedic nutritional counselingBEHAVIORAL

Conventional nutritional counselingBEHAVIORAL

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (2)

Kliniken Essen-Mitte

Essen, Am Deimelsberg 34 A, Germany

Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus

Berlin, Germany

Outcomes

Primary Outcomes

Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) - Change

Time frame: Change from IBS-SSS Baseline at 12 weeks

Secondary Outcomes

Cohen Perceived Stress Scale (CPSS) - Change

Time frame: Change from CPSS Baseline at 4 weeks, 12 weeks and 6 months

Hospital Anxiety and Depression Scale (HADS-D) - Change

Time frame: Change from HADS-D Baseline at 4 weeks, 12 weeks and 6 months

Irritable bowel Syndrome - Quality of life (IBS-QOL) - Change

Time frame: Change from IBS-QOL Baseline at 4 weeks, 12 weeks and 6 months

VAS: Pain, Sleep, General bothersomeness, Expectation - Change

Time frame: Change from VAS Baseline at 4 weeks, 12 weeks and 6 months

Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) - Change

Time frame: Change from IBS-SSS Baseline at 4 weeks and 6 months

Data from ClinicalTrials.gov

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