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

IBS - Irritable Bowel Syndrome Clinical Trial

— AYURDA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03019861
• Other study ID #: AYURDA
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: February 2019

Study information

• Verified date: August 2021
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: February 2019
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• IBS - Irritable Bowel Syndrome
• Irritable Bowel Syndrome
• Syndrome

Intervention

Behavioral:
• Ayurvedic nutritional counseling

• Conventional nutritional counseling

Locations

Country	Name	City	State
Germany	Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus	Berlin
Germany	Kliniken Essen-Mitte	Essen	Am Deimelsberg 34 A

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Stool analysis: Intestinal microbiome by sequencing 16S rRNA		Baseline, 4 weeks
Other	Qualitative interviews in focus groups		Baseline, 6 months
Primary	Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) - Change		Change from IBS-SSS Baseline at 12 weeks
Secondary	Cohen Perceived Stress Scale (CPSS) - Change		Change from CPSS Baseline at 4 weeks, 12 weeks and 6 months
Secondary	Hospital Anxiety and Depression Scale (HADS-D) - Change		Change from HADS-D Baseline at 4 weeks, 12 weeks and 6 months
Secondary	Irritable bowel Syndrome - Quality of life (IBS-QOL) - Change		Change from IBS-QOL Baseline at 4 weeks, 12 weeks and 6 months
Secondary	VAS: Pain, Sleep, General bothersomeness, Expectation - Change		Change from VAS Baseline at 4 weeks, 12 weeks and 6 months
Secondary	Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) - Change		Change from IBS-SSS Baseline at 4 weeks and 6 months