Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2025-12-26 @ 7:52 AM
Study NCT ID:
NCT01418066
Status:
COMPLETED
Last Update Posted:
2012-12-06
First Post:
2011-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ayurvedic Herbs in Diarrhea Predominant Irritable Bowel Syndrome
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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-05', 'studyFirstSubmitDate': '2011-08-15', 'studyFirstSubmitQcDate': '2011-08-15', 'lastUpdatePostDateStruct': {'date': '2012-12-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'irritable bowel syndrome- symptom severity score', 'timeFrame': 'T2 (Day 28)', 'description': 'IBS-SSS(Francis, 1997)'}], 'secondaryOutcomes': [{'measure': 'Frequency of abdominal discomfort/Pain', 'timeFrame': 'last week of treatment (days 21-28)', 'description': 'Diary, daily rating of pain'}, {'measure': 'Intensity of Abdominal Pain/Discomfort', 'timeFrame': 'Last week of treatment (days 21-28)', 'description': 'Diary, daily rating of pain on a 100mm Visual Analog Scale'}, {'measure': 'Stool and diarrhea Frequency', 'timeFrame': 'last week of treatment (days 21-28)', 'description': 'Diary, daily counts'}, {'measure': 'Quality of life', 'timeFrame': 'T2 (Day 28)', 'description': 'measured with the EQ-5D'}, {'measure': 'IBS Specific Quality of life', 'timeFrame': 'T2 (Day 28)', 'description': 'measured with the IBS-QOL (Patrick, 1998)'}, {'measure': 'Depression and Anxiety', 'timeFrame': 'T2 (day 28)', 'description': 'HADS questionnaire (Hermann, 1995)'}, {'measure': 'Adequate Relief Score', 'timeFrame': 'at day 7, 14, 21 and 28', 'description': 'Adequate Relief Score (Mangel, 1998)'}, {'measure': 'Global improvement', 'timeFrame': 'at days 7, 14, 21 and 28', 'description': 'Question on global improvement: How have your symptomes changed compared to the last week: from much worse to much better on a 7-point scale'}, {'measure': 'adverse events', 'timeFrame': 'up to week 15', 'description': 'all adverse events'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Irritable Bowel Syndrome']}, 'descriptionModule': {'briefSummary': 'In the present study the investigators are trying to evaluate the effect of Murraya koenigii leaves, Punica granatum and Curcuma which is administered to the patients in a combined form as tea. This study will help to evaluate the effect of these preparations scientifically in improving the IBS symptoms.', 'detailedDescription': 'see above'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Irritable Bowel Syndrome according to Rom-III\n* Subtype Diarrhea or Alternating\n* discomfort or pain \\> 1 times a week\n* discomfort or pain \\> 4 on a Visual Analog Scale\n\nExclusion Criteria:\n\n* Inflammatory bowel diseases (test results necessary)\n* Lactose, Fructose Malabsorption (test results necessary)\n* Celiac Disease\n* Pregnancy or Breastfeeding\n* Colectomy or Hemicolectomy \\>50cm\n* Severe metabolic disorders, hormonal disorders, cardiac or respiratory failure, liver or renal diseases\n* severe depression, psychotic or psychiatric disorders, substance abuse\n* cancer within the last 5 years\n* allergy to caraway\n* acute inflammatory diseases'}, 'identificationModule': {'nctId': 'NCT01418066', 'acronym': 'AHIB', 'briefTitle': 'Ayurvedic Herbs in Diarrhea Predominant Irritable Bowel Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Universität Duisburg-Essen'}, 'officialTitle': 'Feasibility and Safety of Ayurvedic Herbs in Diarrhoea-predominant Irritable Bowel Syndrome', 'orgStudyIdInfo': {'id': '11-4673 AHIB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Tea decoction made of Graminis Flores abd Maidis stigmata.', 'interventionNames': ['Drug: Placebo tea']}, {'type': 'EXPERIMENTAL', 'label': 'Ayurvedic herbs', 'description': 'Tea decoction made of Murraya koenigii leaves, Punica granatum and Curcuma', 'interventionNames': ['Drug: Ayurvedic Herbs']}], 'interventions': [{'name': 'Ayurvedic Herbs', 'type': 'DRUG', 'description': 'A tea made of Murraya koenigii leaves, Punica granatum and Curcuma as powder. Decoction of 12ml powder in 100ml hot water is taken twice daily at least 30 minutes before a meal.', 'armGroupLabels': ['Ayurvedic herbs']}, {'name': 'Placebo tea', 'type': 'DRUG', 'description': 'Graminis Flores and Maidis stigmata as a powder. Decoction made of 12ml in 100ml hot water. To drink twice daily at least 30 Minutes before a meal.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45276', 'city': 'Essen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Klinik für Naturheilkunde und Integrative Medizin', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}], 'overallOfficials': [{'name': 'Jost Langhorst, Prof., MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Duisburg-Essen, Chair of Integrative Gastroenterology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universität Duisburg-Essen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Jost Langhorst', 'investigatorAffiliation': 'Universität Duisburg-Essen'}}}}