Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2025-12-29 @ 7:52 PM
Study NCT ID:
NCT04767269
Status:
COMPLETED
Last Update Posted:
2021-02-24
First Post:
2021-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Cuminum Cyminum Herbal =Preparation in Inhibition of Plaque and Gingivitis.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '1. Group phase A\n2. Group phase B\n3. Group phase C'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-22', 'studyFirstSubmitDate': '2021-02-09', 'studyFirstSubmitQcDate': '2021-02-20', 'lastUpdatePostDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PLAQUE INDEX', 'timeFrame': 'changes from baseline to 8 days', 'description': 'PLAQUE INDEX: Turesky-Gilmore-Glickman Modification of Quigley Hein 1962'}, {'measure': 'Gingival Index', 'timeFrame': 'changes from baseline to 8 days', 'description': 'Gingival Index: Loe H ans Silness 1963'}, {'measure': 'Bleeding on probing', 'timeFrame': 'changes from baseline to 8 days', 'description': 'Bleeding on probing: Muhlemann HR and Son 1971'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mouthwash', 'chlorhexidine', 'stain'], 'conditions': ['Chronic Gingivitis']}, 'referencesModule': {'references': [{'pmid': '16451766', 'type': 'BACKGROUND', 'citation': 'Southern EN, McCombs GB, Tolle SL, Marinak K. The comparative effects of 0.12% chlorhexidine and herbal oral rinse on dental plaque-induced gingivitis. J Dent Hyg. 2006 Winter;80(1):12. Epub 2006 Jan 1.'}, {'pmid': '19089066', 'type': 'BACKGROUND', 'citation': 'Salgado AD, Maia JL, Pereira SL, de Lemos TL, Mota OM. Antiplaque and antigingivitis effects of a gel containing Punica granatum Linn extract: a double-blind clinical study in humans. J Appl Oral Sci. 2006 Jun;14(3):162-6. doi: 10.1590/s1678-77572006000300003.'}, {'pmid': '20809647', 'type': 'BACKGROUND', 'citation': 'Bettaieb I, Bourgou S, Wannes WA, Hamrouni I, Limam F, Marzouk B. Essential oils, phenolics, and antioxidant activities of different parts of cumin (Cuminum cyminum L.). J Agric Food Chem. 2010 Oct 13;58(19):10410-8. doi: 10.1021/jf102248j.'}]}, 'descriptionModule': {'briefSummary': 'Present work was to investigate the possible efficacy of 0.2% cuminum cyminum herbal preparation as an antiplaque and antigingivitis agent when compared with chlorhexidine.', 'detailedDescription': 'To evaluate and compare the efficacy of 0.2% cuminum cyminum herbal preparation against 0.2% chlorhexidine by various clinical parameters i.e. plaque index, gingival index and sulcus bleeding index.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '23 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* volunteers with minimum 20 natural teeth without restoration.\n* cooperative\n* motivated and committed to participate in the trial period.\n\nExclusion Criteria:\n\n* Antibiotic or anti-inflammatory therapy in previous month.\n* Any known allergy/ hypersensitivity to any product used in trial.'}, 'identificationModule': {'nctId': 'NCT04767269', 'briefTitle': 'Efficacy of Cuminum Cyminum Herbal =Preparation in Inhibition of Plaque and Gingivitis.', 'organization': {'class': 'OTHER', 'fullName': 'Maharishi Markendeswar University (Deemed to be University)'}, 'officialTitle': 'Efficacy of Cuminum Cyminum Herbal Preparation in Inhibition of Plaque and Gingivitis', 'orgStudyIdInfo': {'id': 'MaharishiMu2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cuminum cyminum mouthwash', 'description': 'cuminum cyminum mouthwash in chronic gingivitis patients', 'interventionNames': ['Drug: Cuminum Cyminum']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'herbal mouthwash', 'description': 'herbal mouthwash in chronic gingivitis patients', 'interventionNames': ['Drug: herbal Mouthwash']}], 'interventions': [{'name': 'Cuminum Cyminum', 'type': 'DRUG', 'otherNames': ['Cuminum Cyminum mouthwash'], 'description': 'Cuminum Cyminum mouthwash in chronic gingivitis patients', 'armGroupLabels': ['cuminum cyminum mouthwash']}, {'name': 'herbal Mouthwash', 'type': 'DRUG', 'otherNames': ['herbal mouthwash in chronic gingivitis patients'], 'description': 'herbal mouthwash in chronic gingivitis patients', 'armGroupLabels': ['herbal mouthwash']}]}, 'contactsLocationsModule': {'locations': [{'zip': '133207', 'city': 'Ambāla', 'state': 'Haryana', 'country': 'India', 'facility': 'Department of Periodontology, M.M. College of Dental Sciences and Research.', 'geoPoint': {'lat': 30.36099, 'lon': 76.79782}}], 'overallOfficials': [{'name': 'surinder sachdeva, M.D.S.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PROFESSOR'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maharishi Markendeswar University (Deemed to be University)', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'DR SURINDER SACHDEVA', 'investigatorAffiliation': 'Maharishi Markendeswar University (Deemed to be University)'}}}}