Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-01-04 @ 2:21 AM
Study NCT ID:
NCT00990951
Status:
SUSPENDED
Last Update Posted:
2014-07-08
First Post:
2009-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Efficacy of Association of Senna Alexandrina Mill and Associations on Functional Intestinal Constipation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003248', 'term': 'Constipation'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000081226', 'term': 'Sennosides'}, {'id': 'D001244', 'term': 'Association'}], 'ancestors': [{'id': 'D012676', 'term': 'Senna Extract'}, {'id': 'D000880', 'term': 'Anthraquinones'}, {'id': 'D000095322', 'term': 'Anthrones'}, {'id': 'D000873', 'term': 'Anthracenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011809', 'term': 'Quinones'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010936', 'term': 'Plant Extracts'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D013811', 'term': 'Psychotherapeutic Processes'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'whyStopped': 'The study was interrupted by recruitment failure.', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2014-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-07-07', 'studyFirstSubmitDate': '2009-10-05', 'studyFirstSubmitQcDate': '2009-10-05', 'lastUpdatePostDateStruct': {'date': '2014-07-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'average frequency of bowel movements measured at baseline and at 2 weeks of treatment', 'timeFrame': '2 weeks'}], 'secondaryOutcomes': [{'measure': 'number of consecutive days that patients do not evacuate', 'timeFrame': '2 weeks'}, {'measure': 'Proportion of stools with pain and difficulty', 'timeFrame': '2 weeks'}, {'measure': 'degree of improvement of constipation according to the subjective evaluation of the volunteer, measured by the scores of the Global Assessment of the patient', 'timeFrame': '2 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Constipation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of association of Senna alexandrina Mill (sena), Cassia fistula L., Tamarindus indica L., Coriandrum sativum L., Periandra mediterranea Taub. in patients with functional constipation.', 'detailedDescription': 'This is a phase III trial, placebo-controlled with a parallel-group design.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients between 18-65 years with functional constipation by ROME IIII criteria\n* In the opinion of the investigator the patient will adhere to the protocol\n* Voluntary able to understand the nature and purpose of the study, including the risks and adverse effects and with intent to cooperate with the researcher and act in accordance with the requirements of the entire protocol, which was confirmed by signing the Consent Informed\n\nExclusion Criteria:\n\n* hypersensitivity to any component\n* pregnant or lactating\n* abdominal pain of unknown etiology\n* suspected intestinal occlusion and sub-occlusion\n* suspected abdominal inflammatory conditions (as appendicitis, peritonitis, cystitis, endometritis)\n* Crohn disease and colitis\n* Suspected intestinal constipation due abdominal surgery, neurological disorders (as aganglionoses, Parkinson disease, medullar tumor, stroke, multiple sclerosis), systemic sclerosis, multiple myeloma, scleroderma\n* Subjects with congenital mega colon, anorectal congenital malformation, inflammatory bowel disease or intestinal carcinoma\n* history of mal-absorption diseases\n* history of anemia, weight loss or anal bleeding\n* history of hypothyroidism, hyperthyroidism and insulin-dependent diabetes mellitus\n* known of positive result for human immunodeficiency virus test\n* heart, liver, lung or kidney important condition\n* drug or alcohol dependence\n* knowledge or suspicion of malignancy\n* body mass index \\< 18\n* body mass index \\> 30\n* participation on any experimental study 12 months prior this study\n* familiar history of colon carcinoma or inflammatory disease\n* Lack of adherence to the procedures of the protocol'}, 'identificationModule': {'nctId': 'NCT00990951', 'briefTitle': 'Study of Efficacy of Association of Senna Alexandrina Mill and Associations on Functional Intestinal Constipation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Marjan Industria e Comercio ltda'}, 'officialTitle': 'Double-blind, Randomized, Placebo-controlled Study of Efficacy of Association of Senna Alexandrina, Cassia Fistula, Tamarindus Indica, Coriandrum Sativum, Periandra Mediterranea in Patients With Functional Intestinal Constipation', 'orgStudyIdInfo': {'id': 'MJ 3001-09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Senna alexandrina and associations', 'description': 'Association of Senna alexandrina Mill (sena), Cassia fistula L., Tamarindus indica L., Coriandrum sativum L., Periandra mediterranea Taub', 'interventionNames': ['Drug: Senna alexandrina and associations']}], 'interventions': [{'name': 'Senna alexandrina and associations', 'type': 'DRUG', 'otherNames': ['Brand name: Tamaril'], 'description': 'Drugs: Senna alexandrina Mill (sena), Cassia fistula L., Tamarindus indica L., Coriandrum sativum L., Periandra mediterranea Taub\n\n1 tablet PO twice a day', 'armGroupLabels': ['Senna alexandrina and associations']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ceará', 'state': 'Fortaleza', 'country': 'Brazil', 'facility': 'Departamento de Fisiologia e Farmacologia', 'geoPoint': {'lat': -1.75, 'lon': -44.83333}}], 'overallOfficials': [{'name': 'Maria EA Moraes, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of Ceara - UNIFAC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marjan Industria e Comercio ltda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}