Ayurvedic Nutritional Counseling for Patients With IBS in Comparison to Conventional Nutritional Counseling (AYURDA)

August 2, 2021 updated by: Andreas Michalsen, Charite University, Berlin, Germany

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 14109
        • Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus
    • Am Deimelsberg 34 A
      • Essen, Am Deimelsberg 34 A, Germany, 45276
        • Kliniken Essen-Mitte

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Ayurvedic nutritional counseling
Patients will receive three Ayurvedic nutritional counselings (according to tradition) after 1, 3 and 8 weeks after Baseline.
Behavioral: Ayurvedic nutritional counseling
ACTIVE_COMPARATOR: Conventional nutritional counseling
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Cohen Perceived Stress Scale (CPSS) - Change
Time Frame: Change from CPSS Baseline at 4 weeks, 12 weeks and 6 months
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
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
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
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
Change from IBS-SSS Baseline at 4 weeks and 6 months

Other Outcome Measures

Outcome Measure
Time Frame
Stool analysis: Intestinal microbiome by sequencing 16S rRNA
Time Frame: Baseline, 4 weeks
Baseline, 4 weeks
Qualitative interviews in focus groups
Time Frame: Baseline, 6 months
Baseline, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Andreas Michalsen, Prof. Dr., Charité University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2017

Primary Completion (ACTUAL)

October 1, 2018

Study Completion (ACTUAL)

February 1, 2019

Study Registration Dates

First Submitted

January 2, 2017

First Submitted That Met QC Criteria

January 11, 2017

First Posted (ESTIMATE)

January 13, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 6, 2021

Last Update Submitted That Met QC Criteria

August 2, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AYURDA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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