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

Charité University Medicine Berlin

Status: Completed

Conditions: IBS - Irritable Bowel Syndrome

Treatments: Behavioral: Ayurvedic nutritional counseling; Behavioral: Conventional nutritional counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT03019861

AYURDA

Details and patient eligibility

About

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.

Enrollment: 69 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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69 participants in 2 patient groups

Ayurvedic nutritional counseling

Active Comparator group

Description:

Patients will receive three Ayurvedic nutritional counselings (according to tradition) after 1, 3 and 8 weeks after Baseline.

Treatment:

Behavioral: Ayurvedic nutritional counseling

Conventional nutritional counseling

Active Comparator group

Description:

Patients will receive three conventional nutritional counselings (according to German Nutrition Society - DGE) after 1, 3 and 8 weeks after Baseline.

Treatment:

Behavioral: Conventional nutritional counseling