Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-25 @ 8:58 PM
Study NCT ID:
NCT06098456
Status:
COMPLETED
Last Update Posted:
2024-07-15
First Post:
2023-10-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Epigallocatechin Gallate and Other Antural Compounds in HPV Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C045651', 'term': 'epigallocatechin gallate'}, {'id': 'D014805', 'term': 'Vitamin B 12'}], 'ancestors': [{'id': 'D045728', 'term': 'Corrinoids'}, {'id': 'D045725', 'term': 'Tetrapyrroles'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients decide wheter to receive the experimental treatment or to undergo routine clinical practice.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 178}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-12', 'studyFirstSubmitDate': '2023-10-19', 'studyFirstSubmitQcDate': '2023-10-19', 'lastUpdatePostDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Positivity to HPV infection', 'timeFrame': '3 and 6 months', 'description': 'The outcome consists of the number of negative DNA-test obtained in patients previously positive.'}], 'secondaryOutcomes': [{'measure': 'Occurrence of lesions', 'timeFrame': '3 and 6 months', 'description': 'The outcome consists of the number of negative PAP-tests obtained in patients previously positive.'}, {'measure': 'Lesions-related symptmos', 'timeFrame': '3 and 6 months', 'description': 'The ouctome includes the occurrence of bleeding, flogosis, or sexual pain.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['EGCG', 'HPV', 'Folic acid', 'Hyaluronic acid', 'Vitamin B12', 'LSIL'], 'conditions': ['Papilloma-induced Cervical Lesions']}, 'descriptionModule': {'briefSummary': 'The investigators enroll patients with a PAP-test cytology reporting LSIL or ASCUS.\n\nPateitns undergo HPV-DNA test for screening. Patients are treated with Epigallocatechin galalte, hyaluronic acid, folic acid and Vitamin B12 by oral route.\n\nAfter three months of treatment PAP-test and HPV-DNA test will be repeated.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Positivity to HPV-DNA test\n* PAP-test reporting LSIL or ASCUS\n\nExclusion Criteria:\n\n* HPV-related pathologies or complicances apart from LSIL or ASCUS\n* Diagnosis of cancer'}, 'identificationModule': {'nctId': 'NCT06098456', 'acronym': 'EGCGHPV', 'briefTitle': 'Epigallocatechin Gallate and Other Antural Compounds in HPV Infections', 'organization': {'class': 'NETWORK', 'fullName': 'Centro di Ricerca Clinica Salentino'}, 'officialTitle': 'Treatment With Epigallcoatechin Gallate, Hyaluronic Acid, Folic Acid and Vitamin B12 in Women HPV Positive With Abnormal Cytology Tests', 'orgStudyIdInfo': {'id': 'HPV-EGCG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'The patients in this group undergo treatment with Epigallocatechin gallate 200mg, Hyaluronic acid 50mg, Vitamin B12 1mg and Folic acid 400mcg by oral route once per day.', 'interventionNames': ['Drug: EGCG, FA, HA, B12']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'The patients in this group follow the routine clinical practice, namely the clinical monitoring.'}], 'interventions': [{'name': 'EGCG, FA, HA, B12', 'type': 'DRUG', 'otherNames': ['Pervistop'], 'description': 'Epigallocatechin gallate 200mg, Hyaluronic acid 50mg, Vitamin B12 1mg, Folic acid 400mcg', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73020', 'city': 'Scorrano', 'state': 'Lecce', 'country': 'Italy', 'facility': 'Ospedale Veris delli Ponti', 'geoPoint': {'lat': 40.09018, 'lon': 18.29993}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centro di Ricerca Clinica Salentino', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'ANDREA TINELLI', 'investigatorAffiliation': 'Centro di Ricerca Clinica Salentino'}}}}