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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03019861

Acronym

AYURDA

Enrollment

Registered

2017-01-13

Start date

2017-01-31

Completion date

2019-02-28

Last updated

2021-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IBS - Irritable Bowel Syndrome

Keywords

Ayurveda, IBS, Complementary medicine, nutritional counseling

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.

Interventions

BEHAVIORALAyurvedic nutritional counseling

BEHAVIORALConventional nutritional counseling

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Cohen Perceived Stress Scale (CPSS) - Change	Change from CPSS Baseline at 4 weeks, 12 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
Irritable bowel Syndrome - Quality of life (IBS-QOL) - Change	Change from IBS-QOL 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-Severity Scoring System (IBS-SSS) - Change	Change from IBS-SSS Baseline at 4 weeks and 6 months

Other

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026