Ignite Creation Date:
2025-12-24 @ 11:59 AM
Ignite Modification Date:
2025-12-29 @ 6:54 PM
Study NCT ID:
NCT03511261
Status:
UNKNOWN
Last Update Posted:
2018-04-27
First Post:
2017-01-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Curcumin in Oral Submucous Fibrosis
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D036381', 'term': 'Diarylheptanoids'}, {'id': 'D003474', 'term': 'Curcumin'}], 'ancestors': [{'id': 'D006536', 'term': 'Heptanes'}, {'id': 'D000473', 'term': 'Alkanes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'single blinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'four groups, each group with different formulations.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-17', 'studyFirstSubmitDate': '2017-01-27', 'studyFirstSubmitQcDate': '2018-04-17', 'lastUpdatePostDateStruct': {'date': '2018-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Burning sensation and pain', 'timeFrame': '6 months for each patient', 'description': 'Visual Analogue Scale'}], 'secondaryOutcomes': [{'measure': 'Interincisal distance, tongue protrusion and cheek flexibility', 'timeFrame': '6 months for each patient', 'description': 'All these will be measured in mm at designated time intervals using digital vernier calliper.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Oral submucous fibrosis', 'curcumin', 'potentially malignant disease'], 'conditions': ['Oral Submucous Fibrosis']}, 'referencesModule': {'references': [{'pmid': '26604488', 'type': 'BACKGROUND', 'citation': 'Hazarey VK, Sakrikar AR, Ganvir SM. Efficacy of curcumin in the treatment for oral submucous fibrosis - A randomized clinical trial. J Oral Maxillofac Pathol. 2015 May-Aug;19(2):145-52. doi: 10.4103/0973-029X.164524.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine whether the formulations of curcumin will effect the clinical signs and symptoms and histopathological features in patients with clinical stage 2 oral submucous fibrosis (OSMF).', 'detailedDescription': "200 clinical stage 2 OSMF patients selected randomly by simple random technique with clinically \\& histopathologically confirmed diagnosis are divided into 4 groups with 50 patients each.\n\nIn Group 1 patients are given 10% of curcumin mucoadhesive gel and are instructed to use it topically twice daily making it a daily dose of 1gm.\n\nIn Group 2 patients are given 500mg of curcumin capsules and are instructed to take 2 capsules twice daily making a daily dose of 1gm.\n\nIn Group 3 patients will be given 5% of curcumin mucoadhesive gel and will be instructed to use it topically twice daily \\& 250mg of curcumin capsules to be taken twice daily making it a daily dose of 1gm.\n\nGroup 4 is considered as control group and provided with formulations without the active drug.\n\nThe mean scores of 4 groups will be statistically tested using Anova technique.\n\nThe differences in clinical parameters at 15 days, 1 month, 3 months \\& clinical \\& histopathological paramerters at 6 months will be compared between groups 1, 2, 3 \\& 4 by using students 't' test \\& correlation is also used for knowing the association of variables.\n\nFor all tests, a 'p' value of 0.05 or less will be utilized for statistical significance.\n\nOther non parametric tests can also be applied where ever necessary for data analysis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 200 clinical stage 2 OSMF patients\n\nExclusion Criteria:\n\n* Clinical stage 1 \\& 3 OSMF patients, oromucosal disorders with clinical features same as OSMF, patients who are under treatment, clinically diagnosed cases not ready for incisional biopsy, patients suffering from medically compromised conditions.'}, 'identificationModule': {'nctId': 'NCT03511261', 'acronym': 'ECOSMF', 'briefTitle': 'Efficacy of Curcumin in Oral Submucous Fibrosis', 'organization': {'class': 'OTHER', 'fullName': "H.K.E.S's S.Nijalingappa Institute of Dental Science and Research"}, 'officialTitle': 'Innovative Formulations of Curcumin & Its Comparative Efficacy in Management of Oral Submucous Fibrosis.', 'orgStudyIdInfo': {'id': 'HKESSNDCG/OMR/2014/CT1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '10%Curcumin mucoadhesive gel', 'description': 'Drug: Curcumin arm Curcumin10% mucoadhesive gel\n\nGroup 1 patients:\n\nDrug : 10% curcumin mucoadhesive gel usage : Topical application Frequency : Twice daily Duration : 6 months', 'interventionNames': ['Drug: 10% Curcumin mucoadhesive gel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Curcumin capsules 500mg', 'description': 'Group 2 patients:\n\nDrug : curcumin 500 mg capsules usage : oral intake Frequency : Twice daily Duration : 6 months', 'interventionNames': ['Drug: Curcumin capsules 500mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': '5% Curcumin gel+Curcumin capsules 250mg', 'description': 'Group 3 patients:\n\nDrug: 5% Curcumin mucoadhesive gel \\& Curcumin capsules 250mg usage : Topical application and oral intake Frequency : Twice daily Duration : 6 months', 'interventionNames': ['Drug: 5% curcumin mucoadhesive gel + Curcumin capsules 250 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo capsules', 'description': 'Group 4 patients Drug: Placebo capsules usage : oral intake Frequency : Twice daily Duration : 6 months', 'interventionNames': ['Drug: Placebo capsule']}], 'interventions': [{'name': '10% Curcumin mucoadhesive gel', 'type': 'DRUG', 'otherNames': ['curcuminoid'], 'description': 'Group 1 10%of mucoadhesive gel for topical application two times per day.', 'armGroupLabels': ['10%Curcumin mucoadhesive gel']}, {'name': 'Curcumin capsules 500mg', 'type': 'DRUG', 'otherNames': ['curcuminoid'], 'description': 'Group 2 curcumin 500 mg capsules for oral intake two times per day', 'armGroupLabels': ['Curcumin capsules 500mg']}, {'name': '5% curcumin mucoadhesive gel + Curcumin capsules 250 mg', 'type': 'DRUG', 'otherNames': ['curcuminoid'], 'description': 'Group 3 5% curcumin mucoadhesive gel topical application two times per day + curcumin 250 mg capsules for oral intake two times per day', 'armGroupLabels': ['5% Curcumin gel+Curcumin capsules 250mg']}, {'name': 'Placebo capsule', 'type': 'DRUG', 'otherNames': ['non curcuminoid'], 'description': 'Group 4 placebo capsules for oral intake two times per day', 'armGroupLabels': ['Placebo capsules']}]}, 'contactsLocationsModule': {'locations': [{'zip': '585102', 'city': 'Kalaburagi', 'state': 'Karnataka', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Jayashree Mudda, MDS', 'role': 'CONTACT', 'email': 'jayashreemudda@gmail.com', 'phone': '+919741804012'}], 'facility': "HKE'S S.N Institute of dental sciences & research center", 'geoPoint': {'lat': 17.33583, 'lon': 76.83757}}], 'centralContacts': [{'name': 'Jayashree Mudda, MDS', 'role': 'CONTACT', 'email': 'jayashreemudda@gmail.com', 'phone': '+919741804012'}], 'overallOfficials': [{'name': 'Syeda Arshiya Ara, MDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "HKE'S S.N Institute of dental sciences & research center"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "H.K.E.S's S.Nijalingappa Institute of Dental Science and Research", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor & Research scholar', 'investigatorFullName': 'Syeda Arshiya Ara', 'investigatorAffiliation': "H.K.E.S's S.Nijalingappa Institute of Dental Science and Research"}}}}