Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-27 @ 6:30 AM
Study NCT ID:
NCT05675293
Status:
UNKNOWN
Last Update Posted:
2023-01-11
First Post:
2022-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cervicitis by Iontophoresis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002575', 'term': 'Uterine Cervicitis'}], 'ancestors': [{'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007478', 'term': 'Iontophoresis'}, {'id': 'D000900', 'term': 'Anti-Bacterial Agents'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004586', 'term': 'Electrophoresis'}, {'id': 'D055664', 'term': 'Electrochemical Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D000890', 'term': 'Anti-Infective Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-01-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-09', 'studyFirstSubmitDate': '2022-12-29', 'studyFirstSubmitQcDate': '2022-12-29', 'lastUpdatePostDateStruct': {'date': '2023-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in change in Urine Analysis and Cervical swab results in both groups', 'timeFrame': '7 Days difference between pre and post tests', 'description': 'Presence of Pus Cells in Urine Analysis and a Positive Cervical swab results'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['CERVICITIS']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to:\n\nInvestigate effect of iontophoresis on managing uterine cervicitis.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. All patients have vaginal discharge.\n2. All patients have irregular vaginal bleeding, especially after sexual intercourse.\n3. All patients have dyspareunia.\n4. All patients have Lower abdominal pain.\n5. Group A: 20 women will receive oral medication (antibiotic zesrosin) and hot water with antiseptic.\n6. Group B: 20 women will receive medication by iontophoresis (antibiotic ceftriaxone) and hot water with antiseptic.\n\nExclusion Criteria:\n\n1. Patients with a history of hypersensitivity or adverse reactions associated with the delivered drug in (ceftriaxone).\n2. Patients with prior medical histories of cardiac arrhythmias or hypercoagulability should not receive the procedure near cardiac pacemakers and superficial blood vessels.\n3. In the vicinity of embedded wires, stapes, orthopedic implants, and areas of skin with lesions and impaired sensation.\n4. It either should not be used or used with extreme caution during pregnancy.'}, 'identificationModule': {'nctId': 'NCT05675293', 'briefTitle': 'Cervicitis by Iontophoresis', 'organization': {'class': 'OTHER', 'fullName': 'October 6 University'}, 'officialTitle': 'Effectiveness of Iontophoresis in Managing Uterine Cervicitis', 'orgStudyIdInfo': {'id': 'IONTOPHORESIS FOR CERVICITIS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EXPERIMENTAL ARM', 'interventionNames': ['Device: IONTOPHORESIS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CONTROL ARM', 'interventionNames': ['Drug: ORAL ANTIBIOTIC']}], 'interventions': [{'name': 'IONTOPHORESIS', 'type': 'DEVICE', 'description': 'The process of increasing the penetration of drugs into the skin by application of an electric current', 'armGroupLabels': ['EXPERIMENTAL ARM']}, {'name': 'ORAL ANTIBIOTIC', 'type': 'DRUG', 'description': 'Oral Antibiotic', 'armGroupLabels': ['CONTROL ARM']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'MARIAM HELMY, DEMONSTRATOR', 'role': 'CONTACT', 'email': 'MARIAMHELMYMHR@GMAIL.COM', 'phone': '01129985772'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'October 6 University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Practitioner', 'investigatorFullName': 'MARIAM HELMY', 'investigatorAffiliation': 'October 6 University'}}}}