Ignite Creation Date:
2025-12-26 @ 5:17 PM
Ignite Modification Date:
2025-12-31 @ 11:36 AM
Study NCT ID:
NCT03959306
Status:
UNKNOWN
Last Update Posted:
2019-05-22
First Post:
2019-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Black Seed Oil in Patients With Type 2 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000723271', 'term': 'Nigella sativa oil'}, {'id': 'D007004', 'term': 'Hypoglycemic Agents'}], 'ancestors': [{'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-04-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-05-20', 'studyFirstSubmitDate': '2019-05-18', 'studyFirstSubmitQcDate': '2019-05-20', 'lastUpdatePostDateStruct': {'date': '2019-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect on Markers of Endothelial Dysfunction(The change in the level of soluble intercellular adhesion molecule ( ICAM) in serum using ELISA kit)', 'timeFrame': 'three months', 'description': 'it will be assessed at baseline and after three months of treatment ( to determine the change from baseline at three months ) to determine whether it is effective in reducing marker of endothelial dysfunction (ICAM) in patients with type 2 diabetes mellitus'}], 'secondaryOutcomes': [{'measure': 'Effect on Glycemic Control (Measurement of fasting blood glucose )', 'timeFrame': 'three months', 'description': 'it will be assessed at baseline and after three months of treatment to determine the anti-diabetic effect of black seed oil ( if it is effective in reducing fasting blood glucose from baseline)'}, {'measure': 'Effect on Glycemic Control (Measurement of glycated hemoglobin)', 'timeFrame': 'three months', 'description': 'it will be assessed at baseline and after three months of treatment to determine the anti-diabetic effect of black seed oil ( if it is effective in reducing glycated hemoglobin from baseline)'}, {'measure': 'Effect on Lipid Profile ( Measurement of TC,TG, HDL-C,LDL-C)', 'timeFrame': 'three months', 'description': 'it will be assessed at baseline and after three months of treatment'}, {'measure': 'Effect on Inflammatory Status ( Measurement of High sensitive C-Reactive Protein using ELISA kit)', 'timeFrame': 'three months', 'description': 'it will be assessed at baseline and after three months of treatment'}, {'measure': 'Effect on Quality of Life ( Using Diabetes-39 questionnaire )', 'timeFrame': 'three months', 'description': 'it will be assessed at baseline and after three months of treatment'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Type 2 Diabetes Mellitus', 'Black Seed Oil', 'Endothelial Dysfunction'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effect of black seed oil on markers of endothelial dysfunction in patients with type 2 diabetes mellitus .Also, to investigate its effect on glycemic control ,lipid profile and quality of life of those patients .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age: adult patients with more than or equal 18 years old.\n2. Previous diagnosis of Diabetes mellitus type 2 according to American Diabetes Association Criteria (ADA).\n3. Approval to participate and give informed consent.\n\nExclusion Criteria:\n\n1. Unstable coronary artery disease, cardiac arrhythmia or congestive heart failure.\n2. Uncontrolled hypertension or recent stroke.\n3. Chronic kidney disease or chronic liver disease.\n4. Intake of black seed oil during the previous two months or any other antioxidant.'}, 'identificationModule': {'nctId': 'NCT03959306', 'briefTitle': 'Efficacy of Black Seed Oil in Patients With Type 2 Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Effect of Black Seed Oil on Markers of Endothelial Dysfunction in Patients With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'PHCL14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I', 'description': 'this group of patients will receive their standard anti-diabetic treatment in addition to 1800 mg of black seed oil soft gelatin capsule (900 mg twice daily) for three months', 'interventionNames': ['Dietary Supplement: Black Seed Oil', 'Drug: Anti-Diabetics']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group II', 'description': 'this group of patients will receive their standard anti-diabetic treatment only', 'interventionNames': ['Drug: Anti-Diabetics']}], 'interventions': [{'name': 'Black Seed Oil', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Nigella sativa oil'], 'description': 'Black seed oil soft gelatin capsule', 'armGroupLabels': ['Group I']}, {'name': 'Anti-Diabetics', 'type': 'DRUG', 'description': 'standard anti-diabetic treatment prescribed for the patient', 'armGroupLabels': ['Group I', 'Group II']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain Shams University Hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer of Clinical Pharmacy, Faculty of Pharmacy', 'investigatorFullName': 'Amany Talaat Abdellatif El-Garf', 'investigatorAffiliation': 'Ain Shams University'}}}}