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

Not Applicable

Completed

• Conditions: IBS - Irritable Bowel Syndrome
• Interventions: Behavioral: Ayurvedic nutritional counseling; Behavioral: Conventional nutritional counseling

• 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

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-01-02
• Study First Submitted QC: 2017-01-11
• Study First Posted: 2017-01-13
• Primary Completion: 2018-10
• Study Completion: 2019-02
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-02
• Last Update Posted: 2021-08-06

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

Arm && Interventions

Group	Intervention	Description
Ayurvedic nutritional counseling	Ayurvedic nutritional counseling	Patients will receive three Ayurvedic nutritional counselings (according to tradition) after 1, 3 and 8 weeks after Baseline.
Conventional nutritional counseling	Conventional nutritional counseling	Patients will receive three conventional nutritional counselings (according to German Nutrition Society - DGE) after 1, 3 and 8 weeks after Baseline.

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)

Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus; 🇩🇪 Berlin, Germany

Kliniken Essen-Mitte; 🇩🇪 Essen, Am Deimelsberg 34 A, Germany