Ignite Creation Date:
2025-12-24 @ 12:42 PM
Ignite Modification Date:
2025-12-31 @ 2:33 AM
Study NCT ID:
NCT03019861
Status:
COMPLETED
Last Update Posted:
2021-08-06
First Post:
2017-01-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ayurvedic Nutritional Counseling for Patients With IBS in Comparison to Conventional Nutritional Counseling
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}], 'ancestors': [{'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2019-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-02', 'studyFirstSubmitDate': '2017-01-02', 'studyFirstSubmitQcDate': '2017-01-11', 'lastUpdatePostDateStruct': {'date': '2021-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Stool analysis: Intestinal microbiome by sequencing 16S rRNA', 'timeFrame': 'Baseline, 4 weeks'}, {'measure': 'Qualitative interviews in focus groups', 'timeFrame': 'Baseline, 6 months'}], 'primaryOutcomes': [{'measure': 'Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) - Change', 'timeFrame': 'Change from IBS-SSS Baseline at 12 weeks'}], 'secondaryOutcomes': [{'measure': 'Cohen Perceived Stress Scale (CPSS) - Change', 'timeFrame': 'Change from CPSS Baseline at 4 weeks, 12 weeks and 6 months'}, {'measure': 'Hospital Anxiety and Depression Scale (HADS-D) - Change', 'timeFrame': 'Change from HADS-D Baseline at 4 weeks, 12 weeks and 6 months'}, {'measure': 'Irritable bowel Syndrome - Quality of life (IBS-QOL) - Change', 'timeFrame': 'Change from IBS-QOL Baseline at 4 weeks, 12 weeks and 6 months'}, {'measure': 'VAS: Pain, Sleep, General bothersomeness, Expectation - Change', 'timeFrame': 'Change from VAS Baseline at 4 weeks, 12 weeks and 6 months'}, {'measure': 'Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) - Change', 'timeFrame': 'Change from IBS-SSS Baseline at 4 weeks and 6 months'}]}, 'conditionsModule': {'keywords': ['Ayurveda', 'IBS', 'Complementary medicine', 'nutritional counseling'], 'conditions': ['IBS - Irritable Bowel Syndrome']}, 'referencesModule': {'references': [{'pmid': '34552937', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis "irritable bowel syndrome" according to the ROM-III criteria and the German S3 guideline (Layer 2011)\n* Female and male patients between 18 and 70 years of age\n* Declaration of consent\n\nExclusion Criteria:\n\n* Bad general condition\n* Serious acute or chronic comorbidity\n* Pregnancy and breast feeding period\n* Eating disorder\n* In recognition procedures for early retirement or disability\n* Simultaneous participation in another clinical trial\n* Participation in a clinical trial within the last 3 months before enrollment'}, 'identificationModule': {'nctId': 'NCT03019861', 'acronym': 'AYURDA', 'briefTitle': 'Ayurvedic Nutritional Counseling for Patients With IBS in Comparison to Conventional Nutritional Counseling', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Randomized Controlled Study on Ayurvedic Nutritional Counseling for Patients With Irritable Bowel Syndrome in Comparison to Conventional Nutritional Counseling', 'orgStudyIdInfo': {'id': 'AYURDA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ayurvedic nutritional counseling', 'description': 'Patients will receive three Ayurvedic nutritional counselings (according to tradition) after 1, 3 and 8 weeks after Baseline.', 'interventionNames': ['Behavioral: Ayurvedic nutritional counseling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional nutritional counseling', 'description': 'Patients will receive three conventional nutritional counselings (according to German Nutrition Society - DGE) after 1, 3 and 8 weeks after Baseline.', 'interventionNames': ['Behavioral: Conventional nutritional counseling']}], 'interventions': [{'name': 'Ayurvedic nutritional counseling', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Ayurvedic nutritional counseling']}, {'name': 'Conventional nutritional counseling', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Conventional nutritional counseling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45276', 'city': 'Essen', 'state': 'Am Deimelsberg 34 A', 'country': 'Germany', 'facility': 'Kliniken Essen-Mitte', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '14109', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Andreas Michalsen, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charité University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Andreas Michalsen', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}