Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-04 @ 3:45 AM
Study NCT ID:
NCT02645656
Status:
UNKNOWN
Last Update Posted:
2016-01-05
First Post:
2015-12-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Topical Application of Curcumin Orabase in Oral Submucous Fibrosis (OSMF)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009914', 'term': 'Oral Submucous Fibrosis'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2016-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-01-04', 'studyFirstSubmitDate': '2015-12-29', 'studyFirstSubmitQcDate': '2016-01-04', 'lastUpdatePostDateStruct': {'date': '2016-01-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in OSMF lesion', 'timeFrame': 'up to 6 months', 'description': 'The number of bands and the consistency of the lesion will be evaluated at designated time intervals using appropriate indices.'}], 'secondaryOutcomes': [{'measure': 'Jaw Opening', 'timeFrame': 'up to 6 months', 'description': 'Jaw opening in mm will be measured at designated time intervals using an appropriate instrument.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Oral Submucous Fibrosis', 'Curcumin'], 'conditions': ['Oral Submucous Fibrosis']}, 'descriptionModule': {'briefSummary': 'Curcumin (diferuloylmethane) is the chief component of the spice turmeric and is derived from the rhizome of the East Indian plant Curcuma longa. Curcuma longais a member of the Zingiberacae (ginger) family of botanicals and is a perennial plant that is native to Southeast Asia. Turmeric contains a class of compounds known as the curcuminoids, comprised of curcumin, demethoxy curcumin and bisdemethoxycurcumin.', 'detailedDescription': "Anti-inflammatory mechanisms implicated in the anticarcinogenic potential of curcumin include: (1) inhibition of NF-κB and COX-2 (increased levels of COX-2 are associated with many cancer types); (2)inhibition of arachidonic acid metabolism via lipoxygenase and scavenging of free radicals generated in this pathway; (3) decreased expression of inflammatory cytokines IL-1b, IL-6, and TNF-a, resulting in growth inhibition of cancer cell lines; and (4) down-regulation of enzymes, such as protein kinase C, that mediate inflammation and tumor-cell proliferation.\n\nCurcumin's potent anti-oxidant and free-radical quenching properties play an important role in the inhibitory effects of the compound on the initial stages of carcinogenesis. Antioxidants are implicated in the pathogenesis of OSMF and hence this preparation may be helpful in resolution of this lesion."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '22 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects showing classic clinical signs of OSMF and not under any intervention for the same will be included.\n\nExclusion Criteria:\n\n* Subjects who are receiving or have received any form of therapy in the six month period leading to the study will be excluded.'}, 'identificationModule': {'nctId': 'NCT02645656', 'briefTitle': 'Topical Application of Curcumin Orabase in Oral Submucous Fibrosis (OSMF)', 'organization': {'class': 'OTHER', 'fullName': 'SVS Institute of Dental Sciences'}, 'officialTitle': 'Topical Application of Curcumin Incorporated in Orabase in OSMF Patients', 'orgStudyIdInfo': {'id': 'SVSIDS/OMR/EX1/2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Curcumin Arm', 'description': 'Curcumin gel will be applied in sites with Oral Submucous Fibrosis at designated time intervals.', 'interventionNames': ['Drug: Curcumin Arm']}], 'interventions': [{'name': 'Curcumin Arm', 'type': 'DRUG', 'description': 'Curcumin gel will be applied in sites with Oral Submucous Fibrosis at designated time intervals', 'armGroupLabels': ['Curcumin Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '509002', 'city': 'Hyderabad', 'state': 'Andhra Pradesh', 'country': 'India', 'facility': 'SVS Institute of Dental Sciences, Mahabubnagar'}], 'overallOfficials': [{'name': 'Ramaraju Devaraju, MDS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Academic Commitee'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will be released after publishing the findings.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SVS Institute of Dental Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ethics Committee Investigator', 'investigatorFullName': 'Dr R Viswa Chandra', 'investigatorAffiliation': 'SVS Institute of Dental Sciences'}}}}