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

Sponsor

Charite University, Berlin, Germany (Other)

Overall Status

Completed

CT.gov ID

NCT03019861

Collaborator

(none)

Enrollment

Locations

Arms

Actual Duration (Months)

34.5

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
IBS - Irritable Bowel Syndrome	Behavioral: Ayurvedic nutritional counseling Behavioral: Conventional nutritional counseling	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

69 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

Oct 1, 2018

Actual Study Completion Date :

Feb 1, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) - Change [Change from IBS-SSS Baseline at 12 weeks]

Secondary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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