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

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ClinicalTrials.gov Identifier: NCT03019861
Recruitment Status : Recruiting
First Posted : January 13, 2017
Last Update Posted : January 5, 2018
Sponsor:
Information provided by (Responsible Party):
Andreas Michalsen, Charite University, Berlin, Germany

Brief Summary:
The main goal of this randomized, controlled clinical pilot 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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, Controlled Pilot Study on Ayurvedic Nutritional Counseling for Patients With Irritable Bowel Syndrome in Comparison to Conventional Nutritional Counseling
Study Start Date : January 2017
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2019

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



Primary Outcome Measures :
  1. Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) - Change [ Time Frame: Change from IBS-SSS Baseline at 12 weeks ]

Secondary Outcome Measures :
  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 Outcome Measures:
  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 ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03019861


Contacts
Contact: Miriam Rösner 00493080505682 m.roesner@immanuel.de

Locations
Germany
Kliniken Essen-Mitte Recruiting
Essen, Am Deimelsberg 34 A, Germany, 45276
Contact: Dania Schumann, M. Sc.    +49 (0) 201 174-25508    d.schumann@kliniken-essen-mitte.de   
Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus Recruiting
Berlin, Germany, 14109
Contact: Miriam Rösner, Study nurse    00493080505682    m.roesner@immanuel.de   
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Andreas Michalsen, Prof. Dr. Charité University Medical Center

Responsible Party: Andreas Michalsen, Principal Investigator, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT03019861     History of Changes
Other Study ID Numbers: AYURDA
First Posted: January 13, 2017    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: January 2018

Keywords provided by Andreas Michalsen, Charite University, Berlin, Germany:
Ayurveda
IBS
Complementary medicine
nutritional counseling

Additional relevant MeSH terms:
Syndrome
Irritable Bowel Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases