Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-29 @ 5:34 PM
Study NCT ID:
NCT01732393
Status:
COMPLETED
Last Update Posted:
2012-12-05
First Post:
2012-11-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Quercetin in Prevention and Treatment of Oral Mucositis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D052016', 'term': 'Mucositis'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011794', 'term': 'Quercetin'}], 'ancestors': [{'id': 'D044948', 'term': 'Flavonols'}, {'id': 'D005419', 'term': 'Flavonoids'}, {'id': 'D002867', 'term': 'Chromones'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-04', 'studyFirstSubmitDate': '2012-11-19', 'studyFirstSubmitQcDate': '2012-11-21', 'lastUpdatePostDateStruct': {'date': '2012-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'lower grade of mucositis', 'timeFrame': '3 weeks', 'description': 'grade of mucositis due to WHO criteria'}], 'secondaryOutcomes': [{'measure': 'duration of mucositis', 'timeFrame': '3 weeks of study tiem span and after trial', 'description': 'duration of mucositis due to Who criteria'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Quercetin', 'Chemotherapy', 'Mucositis', 'Hematologic Malignancies'], 'conditions': ['Chemotherapy Induced Oral Mucositis']}, 'descriptionModule': {'briefSummary': 'The study aims to evaluate the effect of Quercetin (a natural flavonoid) on prevention of and treatment of chemotherapy-induced oral mucositis in patients with blood malignancies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient under chemotherapy\n* for a hematologic malignancy\n* the hematologist permits the trial on the patient\n* agreement of patient for participating in the trial\n\nExclusion Criteria:\n\n* presence pf ANY oral lesion at the beginning of the trial\n* loss of follow up\n* use of digoxin and cyclosporine\n* patient death'}, 'identificationModule': {'nctId': 'NCT01732393', 'briefTitle': 'Effect of Quercetin in Prevention and Treatment of Oral Mucositis', 'organization': {'class': 'OTHER', 'fullName': 'Mashhad University of Medical Sciences'}, 'officialTitle': 'Effect of Quercetin in Prevention and Treatment of Chemotherapy Induced Oral Mucositis in Blood Dyscrasias', 'orgStudyIdInfo': {'id': '89470'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'oral quercetin capsules', 'description': 'Patients in the intervention group were administered two, 250 mg Quercetin capsules daily for 3 weeks', 'interventionNames': ['Drug: oral quercetin capsules']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'oral placebo capsules', 'description': 'Patients in the placebo group received two placebo capsules containing lactose .', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'oral quercetin capsules', 'type': 'DRUG', 'description': '10 cases in case group and 10 cases in control group. Patients in the intervention group were administered two, 250 mg Quercetin capsules daily for 3 weeks. Patients in the placebo group received two placebo capsules containing lactose .Patients were examined every other day for evaluation of initiation and severity of oral mucositis.', 'armGroupLabels': ['oral quercetin capsules']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['oral placebo capsules']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91735-498', 'city': 'Mashhad', 'state': 'Khorasan Razavi', 'country': 'Iran', 'facility': 'Oral Medicine Department of Mashhad dental School', 'geoPoint': {'lat': 36.29807, 'lon': 59.60567}}], 'overallOfficials': [{'name': 'Pegah Mosannen Mozafari, assistant professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mashhad University of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mashhad University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor of oral medicine', 'investigatorFullName': 'Pegah Mosannen Mozafari', 'investigatorAffiliation': 'Mashhad University of Medical Sciences'}}}}