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NCT Number: NCT03019861

Ayurvedic Nutritional Counseling for Patients With IBS 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.

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Key information

Conditions

IBS - Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kliniken Essen-Mitte, Essen, Am Deimelsberg 34 A, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ayurvedic nutritional counseling

Behavioral

Conventional nutritional counseling

Behavioral

Primary outcomes

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

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

Secondary outcomes

  1. Cohen Perceived Stress Scale (CPSS) - Change

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

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

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

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

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

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

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

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

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

Other outcomes

  1. Stool analysis: Intestinal microbiome by sequencing 16S rRNA

    Time frame: Baseline, 4 weeks

  2. Qualitative interviews in focus groups

    Time frame: Baseline, 6 months

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

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

Acronym: AYURDA

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jan 13, 2017
Registry last updated
Aug 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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