Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:27 PM
Study NCT ID:
NCT07229469
Status:
COMPLETED
Last Update Posted:
2025-11-17
First Post:
2025-11-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study on Sumac Mouth Rinse for Treating Recurrent Aphthous Stomatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013281', 'term': 'Stomatitis, Aphthous'}, {'id': 'D019226', 'term': 'Oral Ulcer'}], 'ancestors': [{'id': 'D013280', 'term': 'Stomatitis'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Both participants and the outcomes assessor were blinded to the treatment allocation. The Sumac mouth rinse and placebo were identical in appearance, color, and packaging to maintain blinding throughout the study.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A parallel, randomized controlled clinical trial with two groups: one group received Sumac mouth rinse and the control group received Tantum Verde mouth rinse . Participants were randomly assigned to each group. Both participants and the outcomes assessor were blinded to group allocation.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-08-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-13', 'studyFirstSubmitDate': '2025-11-13', 'studyFirstSubmitQcDate': '2025-11-13', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain (VAS)', 'timeFrame': 'At the baseline / Day 2 / Day 6', 'description': 'Visual Analog Scale (VAS) to assess the intensity of oral ulcer pain reported by the patient, where 0 indicates no pain and 10 indicates the worst imaginable pain.'}, {'measure': 'Ulcer size', 'timeFrame': 'At the baseline / Day 2 / Day 6', 'description': 'Measurement of the oral ulcer diameter in millimeters using a ruler or photographic analysis to evaluate ulcer size reduction over time.'}], 'secondaryOutcomes': [{'measure': 'Healing index', 'timeFrame': 'At the baseline / Day 2/ Day 6', 'description': 'Healing index included four categories:\n\n1. Complete reepithelialization\n2. Incomplete reepithelialization\n3. Ulcer\n4. Tissue defect or necrosis'}, {'measure': 'TNF- alpha', 'timeFrame': 'At the baseline/ Day 6', 'description': 'Quantification of the inflammatory cytokine TNF-α in blood or saliva using ELISA to evaluate the inflammatory response associated with oral ulcers.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sumac, Rhus coriaria, mouth rinse, recurrent aphthous stomatitis, oral ulcers, TNF-alpha, anti-inflammatory, herbal therapy, clinical trial'], 'conditions': ['Recurrent Aphthous Stomatitis']}, 'descriptionModule': {'briefSummary': 'This randomized controlled clinical study aims to evaluate the effectiveness of a Sumac mouth rinse in the management of recurrent aphthous stomatitis (RAS). In addition to assessing clinical improvement in ulcer healing and pain reduction, biochemical analysis will be performed by measuring serum TNF-α levels to evaluate the anti-inflammatory effect of Sumac.', 'detailedDescription': 'Recurrent aphthous stomatitis (RAS) is one of the most common oral mucosal disorders, characterized by recurrent, painful ulcers that interfere with eating and speaking. The etiology of RAS is multifactorial and involves immune dysregulation and increased levels of inflammatory cytokines, particularly tumor necrosis factor-alpha (TNF-α).\n\nSumac (Rhus coriaria) is a natural herbal extract known for its anti-inflammatory, antioxidant, and antimicrobial properties. This randomized controlled clinical study aims to evaluate the clinical effectiveness of a Sumac mouth rinse in promoting ulcer healing and reducing pain among patients with recurrent aphthous stomatitis.\n\nIn addition to clinical assessment, biochemical evaluation of serum TNF-α levels will be performed before and after treatment to investigate the possible anti-inflammatory mechanism of Sumac. The study findings are expected to provide new insights into the potential therapeutic role of Sumac in managing RAS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 years or older\n* Systemically healthy\n* Patients with recurrent aphthous stomatitis minor type\n* Duration of ulcer does not exceed 2 days\n* Oral pain score of 4 or higher on the Visual Analog Scale (VAS)\n\nExclusion Criteria:\n\n* Patients with poor oral hygiene\n* Smokers and alcohol users\n* Pregnant or lactating females\n* Patients with a history of any topical or systemic medication or steroid therapy within 1 month prior to the study\n* Vulnerable populations such as prisoners or individuals with mental or physical disabilities'}, 'identificationModule': {'nctId': 'NCT07229469', 'acronym': 'SUMAC-RAS', 'briefTitle': 'A Study on Sumac Mouth Rinse for Treating Recurrent Aphthous Stomatitis', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Sumac Mouth Rinse in the Management of Recurrent Aphthous Stomatitis (A Randomized Controlled Clinical Study With Biochemical Assessment)', 'orgStudyIdInfo': {'id': 'FDASU-ReclM012315'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study group', 'description': 'Study group receiving sumac mouth rinse', 'interventionNames': ['Other: Sumac mouth rinse']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Control group receiving tantum Verde mouth rinse', 'interventionNames': ['Drug: Tantum Verde mouth rinse']}], 'interventions': [{'name': 'Sumac mouth rinse', 'type': 'OTHER', 'description': 'Herbal mouth rinse containing Sumac extract', 'armGroupLabels': ['Study group']}, {'name': 'Tantum Verde mouth rinse', 'type': 'DRUG', 'description': 'Standard mouth rinse according to manufacturer instructions', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11517', 'city': 'Cairo', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': 'Department of oral medicine, Faculty of dentistry, Ain Shams university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}