Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2026-01-02 @ 8:55 AM
Study NCT ID:
NCT05670457
Status:
UNKNOWN
Last Update Posted:
2023-01-04
First Post:
2023-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diosmin as Adjuvant Therapy in Treatment of Non-bleeding Peptic Ulcer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004145', 'term': 'Diosmin'}], 'ancestors': [{'id': 'D047309', 'term': 'Flavones'}, {'id': 'D005419', 'term': 'Flavonoids'}, {'id': 'D002867', 'term': 'Chromones'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-03', 'studyFirstSubmitDate': '2023-01-02', 'studyFirstSubmitQcDate': '2023-01-03', 'lastUpdatePostDateStruct': {'date': '2023-01-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'assesment of improvement of symptoms as indicated by change in SAGIS scale.', 'timeFrame': '2 months', 'description': 'patients will undergo clinical assessment according to SAGIS scale at baseline and 2 months'}], 'secondaryOutcomes': [{'measure': 'change in Malondialdehyde (MDA) serum levels.', 'timeFrame': '2 months', 'description': 'blood samples will be collected at baseline and 2 months.'}, {'measure': 'change in Prostaglandin E2 (PGE2) serum levels.', 'timeFrame': '2 months.', 'description': 'blood samples will be collected at baseline and 2 months.'}, {'measure': 'change in Endothelin-1 (ET-1) serum levels.', 'timeFrame': '2 months', 'description': 'blood samples will be collected at baseline and 2 months.'}, {'measure': 'change in b-cell lymphoma 2(bcl-2) serum levels.', 'timeFrame': '2 months', 'description': 'blood samples will be collected at baseline and 2 months.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-bleeding Peptic Ulcer']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate the safety and efficacy of diosmin as adjuvant therapy in treatment of non-bleeding peptic ulcer patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-. Age 25-65 years old.\n\n* Patients of both gender (male and female).\n* Non-bleeding Peptic ulcer Patients (duodenal \\&gastric) diagnosed by endoscopy.\n\nExclusion Criteria:\n\n* The presence of other factors that can lead to gastric bleeding other than peptic ulcer.\n\n * Patients with cancerous disease\n * Breast-feeding.\n * Surgically altered stomach ( bariatric surgery),\n * Patient with liver disease.\n* Bleeding \\& perforated peptic ulcer.'}, 'identificationModule': {'nctId': 'NCT05670457', 'briefTitle': 'Diosmin as Adjuvant Therapy in Treatment of Non-bleeding Peptic Ulcer', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Diosmin as Adjuvant Therapy in Treatment of Non-bleeding Peptic Ulcer', 'orgStudyIdInfo': {'id': 'diosmin peptic ulcer'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'this group will include 22 patients who will receive anti peptic ulcer only for 2 months.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Diosmin group', 'description': 'this group will include 22 patients who will receive anti peptic ulcer and diosmin 500 mg twice daily for 2 months.', 'interventionNames': ['Drug: Diosmin']}], 'interventions': [{'name': 'Diosmin', 'type': 'DRUG', 'description': 'diosmin 500 mg twice daily', 'armGroupLabels': ['Diosmin group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tanta', 'state': 'El Gharbia', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed G Abdelfatah', 'role': 'CONTACT', 'email': 'ahmed131692@pharm.tanta.edu.eg', 'phone': '201017458534'}], 'facility': 'Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'centralContacts': [{'name': 'Ahmed G Abdelfatah', 'role': 'CONTACT', 'email': 'ahmed131692@pharm.tanta.edu.eg', 'phone': '201017458534'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Ahmed Gamal Salah Abdelfatah', 'investigatorAffiliation': 'Tanta University'}}}}