Ignite Creation Date:
2025-12-25 @ 2:35 AM
Ignite Modification Date:
2026-03-01 @ 1:44 PM
Study NCT ID:
NCT03793634
Status:
UNKNOWN
Last Update Posted:
2019-01-04
First Post:
2019-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Topical Chamomile Versus Topical Triamcinolone Acetonide in Management of Oral Lichen Planus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017676', 'term': 'Lichen Planus, Oral'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D008010', 'term': 'Lichen Planus'}, {'id': 'D017512', 'term': 'Lichenoid Eruptions'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000713170', 'term': 'Chamomile extract'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The supervisor(AA) will be blind. The principle investigator(EN) will supply the patient with the treatment.\n\nThe supervisor (AA) will assess the clinical parameters before treatment , between visits and at the end of the treatment.\n\nStatistician will be blind. Double - blind study.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 37}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-01-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2020-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-03', 'studyFirstSubmitDate': '2019-01-03', 'studyFirstSubmitQcDate': '2019-01-03', 'lastUpdatePostDateStruct': {'date': '2019-01-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain using Numerical rating scale', 'timeFrame': '1 month', 'description': 'Pain measure using Numerical rating scale'}], 'secondaryOutcomes': [{'measure': 'clinical sign score', 'timeFrame': '1 month', 'description': 'Reduction in clinical sign score using Thongprasom et al'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oral Lichen Planus']}, 'descriptionModule': {'briefSummary': 'Using of herbal medications as topical chamomile which has antioxidant, anti-inflammatory and anticarcinogenesis effect with little side effects is the aim for the future treatment of OLP.', 'detailedDescription': 'Oral lichen planus (OLP) is a chronic inflammatory T cell mediated autoimmune disease that affects skin and any mucous membrane particularly oral mucosa.The patient complains of burning sensation, pain; interference with eating, swallowing and speech leading to worsening of quality of life.Oxidative stress plays a role in pathomechanism of OLP disease. Enzymatic and non- enzymatic anti-oxidants act as a physiological guard against reactive oxygen species (ROS) and cytokine-mediated toxicity.Herbal treatment is the aim of the future therapy.Chamomile has anti-oxidant , anti-inflammatory effect and accelerate healing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptomatic OLP.\n* Patients with no history of taking corticosteroids for the last 6 months.\n* Patients who agree to take medication.\n* Medically free\n\nExclusion Criteria:\n\n* Patients with oral lesions other than OLP.\n* Lichenoid reaction .\n* Pregnant females and lactation.\n* Smokers'}, 'identificationModule': {'nctId': 'NCT03793634', 'briefTitle': 'Evaluation of Topical Chamomile Versus Topical Triamcinolone Acetonide in Management of Oral Lichen Planus', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Evaluation of Topical Chamomile Versus Topical Triamcinolone Acetonide in Management of Oral Lichen Planus', 'orgStudyIdInfo': {'id': 'chamomile in OLP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'topical chamomile', 'description': 'herbal medication which has antioxidant, anti-inflammatory and anticarcinogenesis effect.', 'interventionNames': ['Drug: topical chamomile']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Topical Triamcinolone Acetonide', 'description': 'topical triamcinolone acetonide is the gold standard treatment of oral lichen planus.', 'interventionNames': ['Drug: topical chamomile']}], 'interventions': [{'name': 'topical chamomile', 'type': 'DRUG', 'description': 'herbal medication which has antioxidant, anti-inflammatory and anticarcinogenesis effect', 'armGroupLabels': ['Topical Triamcinolone Acetonide', 'topical chamomile']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': '11 saraya st - manial - cairo', 'investigatorFullName': 'Esraa Nashat', 'investigatorAffiliation': 'Cairo University'}}}}