- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03019861
Ayurvedic Nutritional Counseling for Patients With IBS in Comparison to Conventional Nutritional Counseling (AYURDA)
August 2, 2021 updated by: Andreas Michalsen, Charite University, Berlin, Germany
Randomized Controlled Study on Ayurvedic Nutritional Counseling for Patients With Irritable Bowel Syndrome in Comparison to Conventional Nutritional Counseling
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
69
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Berlin, Germany, 14109
- Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus
-
-
Am Deimelsberg 34 A
-
Essen, Am Deimelsberg 34 A, Germany, 45276
- Kliniken Essen-Mitte
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / 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.
|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) - Change
Time Frame: Change from IBS-SSS Baseline at 12 weeks
|
Change from IBS-SSS Baseline at 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cohen Perceived Stress Scale (CPSS) - Change
Time Frame: Change from CPSS Baseline at 4 weeks, 12 weeks and 6 months
|
Change from CPSS Baseline at 4 weeks, 12 weeks and 6 months
|
Hospital Anxiety and Depression Scale (HADS-D) - Change
Time Frame: Change from HADS-D Baseline at 4 weeks, 12 weeks and 6 months
|
Change from HADS-D Baseline at 4 weeks, 12 weeks and 6 months
|
Irritable bowel Syndrome - Quality of life (IBS-QOL) - Change
Time Frame: Change from IBS-QOL Baseline at 4 weeks, 12 weeks and 6 months
|
Change from IBS-QOL Baseline at 4 weeks, 12 weeks and 6 months
|
VAS: Pain, Sleep, General bothersomeness, Expectation - Change
Time Frame: Change from VAS Baseline at 4 weeks, 12 weeks and 6 months
|
Change from VAS Baseline at 4 weeks, 12 weeks and 6 months
|
Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) - Change
Time Frame: Change from IBS-SSS Baseline at 4 weeks and 6 months
|
Change from IBS-SSS Baseline at 4 weeks and 6 months
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Stool analysis: Intestinal microbiome by sequencing 16S rRNA
Time Frame: Baseline, 4 weeks
|
Baseline, 4 weeks
|
Qualitative interviews in focus groups
Time Frame: Baseline, 6 months
|
Baseline, 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Andreas Michalsen, Prof. Dr., Charité University Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2017
Primary Completion (ACTUAL)
October 1, 2018
Study Completion (ACTUAL)
February 1, 2019
Study Registration Dates
First Submitted
January 2, 2017
First Submitted That Met QC Criteria
January 11, 2017
First Posted (ESTIMATE)
January 13, 2017
Study Record Updates
Last Update Posted (ACTUAL)
August 6, 2021
Last Update Submitted That Met QC Criteria
August 2, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AYURDA
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on IBS - Irritable Bowel Syndrome
-
Guy BoeckxstaensFund for Scientific Research, Flanders, BelgiumRecruiting
-
Kyle Staller, MD, MPHArdelyxRecruitingIBS - Irritable Bowel Syndrome | IBSUnited States
-
University of California, Los AngelesRecruitingIBS - Irritable Bowel SyndromeUnited States
-
AstraZenecaCompletedIrritable Bowel Syndrome-IBSChina
-
Arizona State UniversityCompletedIBS - Irritable Bowel SyndromeUnited States
-
Xiyuan Hospital of China Academy of Chinese Medical...UnknownIBS (Irritable Bowel Syndrome)China
-
Seton Healthcare FamilyWithdrawnIrritable Bowel Syndrome (IBS)United States
-
Glycom, Inc.University of North CarolinaCompletedIrritable Bowel Syndrome (IBS)United States
-
GlaxoSmithKlineCompletedIrritable Bowel Syndrome (IBS)United States
-
The Royal Wolverhampton Hospitals NHS TrustRecruiting
Clinical Trials on Ayurvedic nutritional counseling
-
Hospital de Clinicas de Porto AlegreActive, not recruitingBinge-Eating Disorder | Cognitive Behavioral Therapy | Transcranial Direct Current StimulationBrazil
-
University of PadovaFondazione Guido Berlucchi; Veneto Institute of Oncology I.O.V.-I.R.C.C.S.Terminated
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedCancer SurvivorUnited States
-
William Carey UniversityUniversity of Mississippi Medical Center; University of Southern MississippiCompletedSpinal Cord InjuriesUnited States
-
Société des Produits Nestlé (SPN)CompletedPicky Eating BehaviorsChina
-
IRCCS Policlinico S. MatteoRecruitingNutritional SupportItaly
-
Medical University of GrazRecruitingDepressive Disorder | Sleep | Psychological Stress | Nutritional Quality | Burn-out SyndromeAustria
-
Federico II UniversityUnknown
-
Hanoi Medical UniversityMinistry of Health of Vietnam; Hanoi Medical University HospitalCompletedGastric Cancer | Colon Cancer