Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2026-02-19 @ 9:10 PM
Study NCT ID:
NCT02816957
Status:
UNKNOWN
Last Update Posted:
2017-04-26
First Post:
2016-06-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Benefits of Nigella Sativa in Children With Beta Thalassemia Major
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-24', 'studyFirstSubmitDate': '2016-06-23', 'studyFirstSubmitQcDate': '2016-06-26', 'lastUpdatePostDateStruct': {'date': '2017-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'malondialdehyde', 'timeFrame': '3 months', 'description': 'nmol serum level of malondialdehyde (nmol per liter)'}, {'measure': 'cluster of differentation4 and 8(CD4 and CD8)', 'timeFrame': '3 months', 'description': 'CD4 and CD8 cell per cmm'}, {'measure': 'total antioxidant', 'timeFrame': '3 months', 'description': 'total antioxidant(mmol per liter)'}], 'secondaryOutcomes': [{'measure': 'Serum iron', 'timeFrame': '3 months', 'description': 'microgram per dl'}, {'measure': 'total iron binding capacity', 'timeFrame': '3 months', 'description': 'microgram per dl'}, {'measure': 'serum ferritin', 'timeFrame': '3 months', 'description': 'ng per ml'}, {'measure': 'complete blood count', 'timeFrame': '3 months', 'description': 'complete blood count'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Nigella Sativa With Beta Thalassemia Major']}, 'descriptionModule': {'briefSummary': 'Evaluate the therapeutic effects health benefits, and immunological effect of Nigella sativa in children with beta thalassemia major.', 'detailedDescription': 'Study will be carried on children patients with β- thalassemia major attending The Hematology Unit of Pediatric Department at Tanta University Hospital. patients are divided into 2 groups: patients in the control group, patients in the treatment group that will receive nigella sativa powder for 3 consecutive months. Then Evaluate the therapeutic effects health benefits, and immunological effect of Nigella sativa in children with beta thalassemia major.\n\nEvaluate the extent of clinical improvement, reductions in serum iron and ferritin, antioxidant status, treatment of the causes of hemolysis and other therapeutic benefits of Nigella sativa in those patient.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Thalassemia with iron overload\n\nExclusion Criteria:\n\n* Thalassemia complicated with diabetes mellitus or hepatitis\n* Patients who discontinue treatment'}, 'identificationModule': {'nctId': 'NCT02816957', 'acronym': 'Nigella', 'briefTitle': 'Benefits of Nigella Sativa in Children With Beta Thalassemia Major', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Study of The Therapeutic Benefits of Nigella Sativa in Children With Beta Thalassemia Major', 'orgStudyIdInfo': {'id': '30794l03l16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'patients receiving Nigella', 'description': '40 patients in the treatment group that will receive nigella sativa powder (2 gm/day) for 3 consecutive months.', 'interventionNames': ['Drug: nigella sativ']}, {'type': 'NO_INTERVENTION', 'label': 'patients not received nigella as controls', 'description': '40 patients in the control group will not receive nigella sativa and continued on the usual chelators'}], 'interventions': [{'name': 'nigella sativ', 'type': 'DRUG', 'description': 'nigella sativa powder (2 gm/day) for 3 consecutive months.', 'armGroupLabels': ['patients receiving Nigella']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0000', 'city': 'Tanta', 'state': 'Gharbia Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohamed R El-Shanshory, MD', 'role': 'CONTACT', 'email': 'elshanshory@gmail.com', 'phone': '+201005680834'}, {'name': 'Nahed M Hablas, MD', 'role': 'CONTACT', 'email': 'nahedhablas79@gmail.com', 'phone': '+201010560350'}, {'name': 'Mohamed M El-Shanshory, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Nahed AR Hablas, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Salah M El Sayed, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Faculty of Medicine- Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'centralContacts': [{'name': 'Nahed Mohamed Habas, MD', 'role': 'CONTACT', 'email': 'nahedhablas79@gmail.com', 'phone': '01010560350'}, {'name': 'Nahed moh Hablas, MD', 'role': 'CONTACT', 'email': 'nahedhabls79@gmail.com', 'phone': '00201010560350'}], 'overallOfficials': [{'name': 'Mohamed Ramadan ELshanshory, prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'professor of pediatrics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}