Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT06836102
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-20
First Post:
2025-02-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Usage of Orange Peel Extract in Management of Epistaxis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004844', 'term': 'Epistaxis'}], 'ancestors': [{'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-15', 'studyFirstSubmitDate': '2025-02-15', 'studyFirstSubmitQcDate': '2025-02-15', 'lastUpdatePostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The potential of nano-based gel of Orange peel extract in management of epistaxis', 'timeFrame': 'From enrollment to the end of treatment at 4 weeks', 'description': 'assessment of epistaxis ( amount, severity and frequency ) according to ESS ( Epistaxis Severity Score ) between patients in study groups'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Epistaxis']}, 'referencesModule': {'availIpds': [{'id': 'drmostafanasr1988@gmail.com', 'url': 'https://doi.org/10.1016/j.hermed.2021.100468', 'type': 'Study Protocol'}], 'references': [{'pmid': '36670900', 'type': 'BACKGROUND', 'citation': 'Andrade MA, Barbosa CH, Shah MA, Ahmad N, Vilarinho F, Khwaldia K, Silva AS, Ramos F. Citrus By-Products: Valuable Source of Bioactive Compounds for Food Applications. Antioxidants (Basel). 2022 Dec 25;12(1):38. doi: 10.3390/antiox12010038.'}], 'seeAlsoLinks': [{'url': 'https://www.aafp.org/pubs/afp/issues/2018/0815/p240.html', 'label': 'Epistaxis: Outpatient Management'}]}, 'descriptionModule': {'briefSummary': 'Efficacy of orange peel extract in treatment of epistaxis in children', 'detailedDescription': 'Formulation of orange peel extract into gel substance and usage of it in local treatment of epistaxis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* children with anterior epistaxis from little's area\n\nExclusion Criteria:\n\n* patient with nasal polyp.\n* patients with hematological abnormalities.\n* patients with general diseases affecting coagulation system."}, 'identificationModule': {'nctId': 'NCT06836102', 'briefTitle': 'Usage of Orange Peel Extract in Management of Epistaxis', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'The Potential of Nano-based Gel of Orange Peel Extract in Management of Epistaxis : a Randomized Double Blind Clinical Study', 'orgStudyIdInfo': {'id': 'orange peel in epistaxis'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'gel of Orange peel extract', 'description': 'usage of gel of Orange peel extract as a local treatment of epistaxis', 'interventionNames': ['Dietary Supplement: Orange']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'nano-based gel of Orange peel extract', 'description': 'usage of nano-based gel of Orange peel extract as a local treatment of epistaxis', 'interventionNames': ['Dietary Supplement: Orange']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'usage of placebo in control cases', 'interventionNames': ['Dietary Supplement: Orange']}], 'interventions': [{'name': 'Orange', 'type': 'DIETARY_SUPPLEMENT', 'description': 'usage of orange peel extract in gel layer in treatment of epistaxis', 'armGroupLabels': ['gel of Orange peel extract', 'nano-based gel of Orange peel extract', 'placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mostafa Nasr Ahmed, consultant', 'role': 'CONTACT', 'email': 'drmostafanasr1988@gmail.com', 'phone': '+201007905656'}, {'name': 'Hanaa Bahaa El-khouly, consultant of pharmacognosy', 'role': 'CONTACT', 'email': 'hanaa.bahaaelkhouly@yahoo.com', 'phone': '+201001616758'}]}, 'ipdSharingStatementModule': {'url': 'http://drmostafanasr1988@gmail.com', 'infoTypes': ['ICF', 'CSR'], 'timeFrame': '3 months', 'ipdSharing': 'YES', 'description': 'result', 'accessCriteria': 'contact by emailing'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of otorhinolaryngology Minia university', 'investigatorFullName': 'Mostafa Nasr Zayed', 'investigatorAffiliation': 'Minia University'}}}}