Ignite Creation Date:
2025-12-24 @ 12:19 PM
Ignite Modification Date:
2025-12-28 @ 5:23 AM
Study NCT ID:
NCT05822661
Status:
UNKNOWN
Last Update Posted:
2023-04-21
First Post:
2023-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Black Seed Oil on Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000723271', 'term': 'Nigella sativa oil'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Drug vs placebo'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-04-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-08', 'studyFirstSubmitDate': '2023-02-28', 'studyFirstSubmitQcDate': '2023-04-08', 'lastUpdatePostDateStruct': {'date': '2023-04-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'serum Endothelin-1 (ET-1) level', 'timeFrame': '8 weeks', 'description': 'marker of endothelial dysfunction'}], 'secondaryOutcomes': [{'measure': 'Serum malondialdehyde (MDA) and total antioxidant capacity (TAC)', 'timeFrame': '8 weeks', 'description': 'markers of oxidative stress'}, {'measure': 'Quality of life questionnaire', 'timeFrame': '4 weeks and 8 weeks', 'description': 'using validated Arabic version SF-36 questionnaire'}, {'measure': 'Fatigue severity', 'timeFrame': '4 weeks and 8 weeks', 'description': 'using the Multidimensional Fatigue Inventory (MFI)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['black seed oil', 'nigella sativa', 'hemodialysis'], 'conditions': ['End Stage Renal Disease']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate the effect of black seed oil on endothelial dysfunction, oxidative stress and quality of life in hemodialysis patients.', 'detailedDescription': 'Evaluation of the effect of black seed oil in hemodialysis patients via:\n\n* Evaluation of serum Endothelin-1 levels\n* Evaluation of serum Malondialdehyde (MDA) levels\n* Evaluation of serum Total Antioxidant Capacity (TAC) levels\n* Evaluation of Quality of Life (QOL)\n* Evaluation of fatigue scale'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 20 years old\n* Three to four times per week hemodialysis\n* Being on hemodialysis for at least 6 months\n* Ability and willingness to cooperate in the study\n\nExclusion Criteria:\n\n* Pregnancy or lactation\n* Cigarette smoking or substance/alcohol abuse\n* Having active infectious diseases\n* Receiving steroidal or nonsteroidal anti-inflammatory drugs\n* Using Nigella sativa oil regularly\n* Changes in treatment methods (dialysis) or medications during the supplementation'}, 'identificationModule': {'nctId': 'NCT05822661', 'briefTitle': 'Impact of Black Seed Oil on Hemodialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Evaluation of the Impact of Black Seed Oil on Hemodialysis Patients', 'orgStudyIdInfo': {'id': '119'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Black Seed Oil', 'description': '900 mg (as two separate soft gels) twice daily for 8 weeks', 'interventionNames': ['Dietary Supplement: Black Seed Oil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'matched placebo capsules', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Black Seed Oil', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Nigella sativa'], 'description': 'Dietary supplement', 'armGroupLabels': ['Black Seed Oil']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'placebo capsules same odor, color and size as the drug but without the active ingredient', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain Shams University Hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'May A Shawki, PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculty of pharmacy - Ain Shams University'}, {'name': 'Areej M Ateya, PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculty of pharmacy - Ain Shams University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}