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

NCT ID: NCT03019861

Last Updated: 2021-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2019-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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IBS - Irritable Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ayurvedic nutritional counseling

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

Group Type ACTIVE_COMPARATOR

Ayurvedic nutritional counseling

Intervention Type BEHAVIORAL

Conventional nutritional counseling

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

Group Type ACTIVE_COMPARATOR

Conventional nutritional counseling

Intervention Type BEHAVIORAL

Interventions

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Ayurvedic nutritional counseling

Intervention Type BEHAVIORAL

Conventional nutritional counseling

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Andreas Michalsen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andreas Michalsen, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Charité University Medical Center

Locations

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Kliniken Essen-Mitte

Essen, Am Deimelsberg 34 A, Germany

Site Status

Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus

Berlin, , Germany

Site Status

Countries

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Germany

References

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Jeitler M, Wottke T, Schumann D, Puerto Valencia LM, Michalsen A, Steckhan N, Mittwede M, Stapelfeldt E, Koppold-Liebscher D, Cramer H, Wischnewsky M, Murthy V, Kessler CS. Ayurvedic vs. Conventional Nutritional Therapy Including Low-FODMAP Diet for Patients With Irritable Bowel Syndrome-A Randomized Controlled Trial. Front Med (Lausanne). 2021 Sep 6;8:622029. doi: 10.3389/fmed.2021.622029. eCollection 2021.

Reference Type DERIVED
PMID: 34552937 (View on PubMed)

Other Identifiers

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AYURDA

Identifier Type: -

Identifier Source: org_study_id

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