Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT05952102
Status:
RECRUITING
Last Update Posted:
2024-02-14
First Post:
2023-07-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nigella Sativa as an Adjuvant Therapy in the Treatment of Pediatric Pneumonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000723271', 'term': 'Nigella sativa oil'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 104}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-11', 'studyFirstSubmitDate': '2023-07-11', 'studyFirstSubmitQcDate': '2023-07-11', 'lastUpdatePostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Respiratory rate', 'timeFrame': '3 days', 'description': 'Time taken for normalization of respiratory rate'}, {'measure': 'Temperature', 'timeFrame': '3 days', 'description': 'Duration of defeverness'}, {'measure': 'Oxygen saturation', 'timeFrame': '3 days', 'description': 'Duration of normal oxygen saturation'}, {'measure': 'Feeding', 'timeFrame': '3 days', 'description': 'Duration of improvement of feeding'}, {'measure': 'Respiratory distress', 'timeFrame': '7 days', 'description': 'Duration of improvement of respiratory distress'}, {'measure': 'Hospital stays', 'timeFrame': '14 days', 'description': 'Duration of hospital stay'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '30 days', 'description': 'Discharge or death of the patient'}, {'measure': 'Pneumonia complications', 'timeFrame': '30 days', 'description': 'Occurrence of pneumonia complications'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nigella Sativa Oil', 'Pneumonia'], 'conditions': ['Nigella Sativa Oil as an Adjuvant Therapy in the Treatment of Pneumonia']}, 'descriptionModule': {'briefSummary': "Nigella sativa is the world's oldest immunomodulator. The main active component in Nigella sativa is thymoquinone. Research shows thymoquinone has antioxidant, anti-inflammatory, and antimicrobial effects. Based on these observations on the pharmacological activities of Nigella sativa, the potential therapeutic efficacy of N. Sativa was proposed in CAP.", 'detailedDescription': 'The aim of this work is to assess the benefit of oral Nigella Sativa oil supplementation, in addition to standard antibiotic and other supportive therapy, in the management of hospitalized children with pneumonia admitted to the Pulmonology Unit, Pediatric Department.\n\nPrimary outcome:\n\n1- The duration of clinical manifestations of pneumonia including time taken for normalization of respiratory rate, temperature, and oxygen.\n\nsaturation, chest in drawing, hypoxia, lethargy, and inability to feed 2- The duration of hospital stay.\n\nSecondary outcome:\n\n1. Discharge or death of the patient.\n2. Occurrence of pneumonia complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signs and symptoms of lower respiratory tract infections (LRTI) (LRTI was defined as ≥ 1 of the following: new or different cough or sputum production, chest pain, dyspnea, tachypnea, or abnormal auscultatory findings).\n* Focal findings on chest x-ray indicating pneumonia.\n\nExclusion Criteria:\n\n* Children with immunodeficiency, chronic lung disease, malignancy, congenital lung anomalies, underlying disorder impacting respiration i.e. genetic, metabolic, neuromuscular disorders….etc, children with CHD affecting the pulmonary blood flow'}, 'identificationModule': {'nctId': 'NCT05952102', 'briefTitle': 'Nigella Sativa as an Adjuvant Therapy in the Treatment of Pediatric Pneumonia', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Role of Nigella Sativa Oil as an Adjuvant Therapy in the Treatment of Pediatric Pneumonia', 'orgStudyIdInfo': {'id': 'Nigella Sativa in Pneumonia'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '52 children with community acquired pneumonia will receive Nigella sativa oil capsules', 'description': '52 children with community-acquired pneumonia will receive Nigella sativa oil in capsules at a dose of 40 mg/kg/day (8), as an adjunct therapy to the usual pneumonia treatment till the recovery of the disease.', 'interventionNames': ['Drug: Nigella Sativa Oil capsule']}, {'type': 'NO_INTERVENTION', 'label': '52 children', 'description': '52 children with community-acquired pneumonia with the usual pneumonia treatment as a control group'}], 'interventions': [{'name': 'Nigella Sativa Oil capsule', 'type': 'DRUG', 'otherNames': ['Black seed oil capsule'], 'description': 'Nigella Sativa Oil as an Adjuvant Therapy in the Treatment of Pediatric Pneumonia', 'armGroupLabels': ['52 children with community acquired pneumonia will receive Nigella sativa oil capsules']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Tanta', 'state': 'Gharbia Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Rehab Zaki Elmeazawy, MD', 'role': 'CONTACT', 'email': 'rehab.elmeazawy@med.tanta.edu.eg', 'phone': '01004815280'}, {'name': 'Ahmed A. Aboelezz, MD', 'role': 'CONTACT', 'email': 'ahmed.abouelaaz1@med.tanta.edu.eg', 'phone': '01005323714'}], 'facility': 'Faculty of Medicine', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'centralContacts': [{'name': 'Rehab Zaki Elmeazawy, MD', 'role': 'CONTACT', 'email': 'rehab.elmeazawy@med.tanta.edu.eg', 'phone': '01004815280'}, {'name': 'Ahmed A. Aboelezz, MD', 'role': 'CONTACT', 'email': 'ahmed.abouelaaz1@med.tanta.edu.eg', 'phone': '01005323714'}], 'overallOfficials': [{'name': 'Asmaa E. Fayed, MBBS', 'role': 'STUDY_CHAIR', 'affiliation': 'Tanta University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rehab Zaki Elmeazawy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Rehab Zaki Elmeazawy', 'investigatorAffiliation': 'Tanta University'}}}}