Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-03-04 @ 8:12 PM
Study NCT ID:
NCT04401202
Status:
COMPLETED
Last Update Posted:
2021-05-26
First Post:
2020-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Nigella Sativa in COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000723271', 'term': 'Nigella sativa oil'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aekoshak@kau.edu.sa', 'phone': '0543292333', 'title': 'Dr. Abdulrahman Koshak', 'organization': 'King Abdulaziz University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '14 days', 'eventGroups': [{'id': 'EG000', 'title': 'Nigella Sativa Oil', 'description': 'Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days', 'otherNumAtRisk': 87, 'deathsNumAtRisk': 87, 'otherNumAffected': 3, 'seriousNumAtRisk': 87, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Standard of care', 'otherNumAtRisk': 86, 'deathsNumAtRisk': 86, 'otherNumAffected': 0, 'seriousNumAtRisk': 86, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Gastrointestinal symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Clinical Recovery Within 14 Days After Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nigella Sativa Oil', 'description': 'Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days'}, {'id': 'OG001', 'title': 'Control', 'description': 'Standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 14', 'description': 'The Percentage of patients who had clinical recovery within 14 days after randomization (clinical recovery was defined as three days of no symptoms)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Number of Days to Recovery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nigella Sativa Oil', 'description': 'Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days'}, {'id': 'OG001', 'title': 'Control', 'description': 'Standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '14'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '11', 'upperLimit': '14'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 14', 'description': 'The number of days to recovery (number of symptomatic days)', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Each Symptom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nigella Sativa Oil', 'description': 'Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days\n\nNigella sativa oil: Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days'}, {'id': 'OG001', 'title': 'Control', 'description': 'Standard of care'}], 'classes': [{'title': 'Anosmia', 'categories': [{'measurements': [{'value': '8.5', 'spread': '3.9', 'groupId': 'OG000'}, {'value': '10.4', 'spread': '3.6', 'groupId': 'OG001'}]}]}, {'title': 'Runny nose', 'categories': [{'measurements': [{'value': '2.5', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '2.5', 'groupId': 'OG001'}]}]}, {'title': 'Loss of appetite', 'categories': [{'measurements': [{'value': '3.5', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '3.1', 'groupId': 'OG001'}]}]}, {'title': 'Chills', 'categories': [{'measurements': [{'value': '2.1', 'spread': '1', 'groupId': 'OG000'}, {'value': '4.9', 'spread': '3.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 14', 'description': 'Duration of each symptom in days', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Side Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nigella Sativa Oil', 'description': 'Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days'}, {'id': 'OG001', 'title': 'Control', 'description': 'Standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 14', 'description': 'Side effects from the investigational treatment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hospital Admission Due to Disease Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nigella Sativa Oil', 'description': 'Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days'}, {'id': 'OG001', 'title': 'Control', 'description': 'Standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 14', 'description': 'High severity of COVID-19 (mild cases does not require hospitalization)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control', 'description': 'Standard of care'}, {'id': 'FG001', 'title': 'Nigella Sativa Oil', 'description': 'Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '92'}, {'groupId': 'FG001', 'numSubjects': '91'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '86'}, {'groupId': 'FG001', 'numSubjects': '87'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Hospitalized', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': '233 cases assessed for eligibility. 50 cases were excluded because; Asymptomatic (31), Pregnant (3), Declined to participate (n= 7), Failed communication (n= 9)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Nigella Sativa Oil', 'description': 'Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days'}, {'id': 'BG001', 'title': 'Control', 'description': 'Standard of care'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '35', 'spread': '10', 'groupId': 'BG000'}, {'value': '35', 'spread': '11', 'groupId': 'BG001'}, {'value': '35', 'spread': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '27.1', 'spread': '6.1', 'groupId': 'BG000'}, {'value': '27.2', 'spread': '5.5', 'groupId': 'BG001'}, {'value': '27.1', 'spread': '5.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Smoker', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Pre-enrollment days', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '2.1', 'groupId': 'BG000'}, {'value': '4', 'spread': '3.1', 'groupId': 'BG001'}, {'value': '3.7', 'spread': '2.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The time from the first day of symptoms until the day of enrollment', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-07-14', 'size': 497370, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-05-23T05:15', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, randomized, open-label, controlled clinical study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 183}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-25', 'studyFirstSubmitDate': '2020-05-21', 'resultsFirstSubmitDate': '2021-05-23', 'studyFirstSubmitQcDate': '2020-05-22', 'lastUpdatePostDateStruct': {'date': '2021-05-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-25', 'studyFirstPostDateStruct': {'date': '2020-05-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Clinical Recovery Within 14 Days After Randomization', 'timeFrame': 'Day 14', 'description': 'The Percentage of patients who had clinical recovery within 14 days after randomization (clinical recovery was defined as three days of no symptoms)'}], 'secondaryOutcomes': [{'measure': 'The Number of Days to Recovery', 'timeFrame': 'Day 14', 'description': 'The number of days to recovery (number of symptomatic days)'}, {'measure': 'Duration of Each Symptom', 'timeFrame': 'Day 14', 'description': 'Duration of each symptom in days'}, {'measure': 'Side Effects', 'timeFrame': 'Day 14', 'description': 'Side effects from the investigational treatment'}, {'measure': 'Hospital Admission Due to Disease Complications', 'timeFrame': 'Day 14', 'description': 'High severity of COVID-19 (mild cases does not require hospitalization)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'SARS-CoV-2', 'Nigella sativa', 'Herbal'], 'conditions': ['COVID-19', 'SARS-CoV-2']}, 'referencesModule': {'references': [{'pmid': '34407441', 'type': 'DERIVED', 'citation': 'Koshak AE, Koshak EA, Mobeireek AF, Badawi MA, Wali SO, Malibary HM, Atwah AF, Alhamdan MM, Almalki RA, Madani TA. Nigella sativa for the treatment of COVID-19: An open-label randomized controlled clinical trial. Complement Ther Med. 2021 Sep;61:102769. doi: 10.1016/j.ctim.2021.102769. Epub 2021 Aug 15.'}, {'pmid': '32771034', 'type': 'DERIVED', 'citation': 'Koshak AE, Koshak EA, Mobeireek AF, Badawi MA, Wali SO, Malibary HM, Atwah AF, Alhamdan MM, Almalki RA, Madani TA. Nigella sativa supplementation to treat symptomatic mild COVID-19: A structured summary of a protocol for a randomised, controlled, clinical trial. Trials. 2020 Aug 8;21(1):703. doi: 10.1186/s13063-020-04647-x.'}]}, 'descriptionModule': {'briefSummary': 'Natural products with immunomodulation and antiviral activity showed a promising improvement in the outcomes of some viral infectious diseases both in preclinical and primitive clinical studies. The aim of this study is to utilize Saudi FDA licensed Nigella sativa (NS) seed oil towards improving disease outcomes in adult patients diagnosed with mild COVID-19. The study will be a prospective, open-label, non-randomized controlled pilot trial. Patients will be supplemented (add-on) with one capsule of black seed oil twice daily for 10 days. The primary outcome will be the proportion of patients who clinically recovered on day 14. The secondary outcomes will be clinical parameters and routine laboratory tests. If encouraging outcomes occurred, NS supplementation may be recommended as an add-on to standard care protocol to enhance the recovery from COVID-19 disease in the current emerging situation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with mild COVID19 upper respiratory tract infection and with no evidence of pneumonia\n* Adult (18 Years and above)\n* Written informed consent prior to initiation of any study procedures by the patient (or legally authorized representative).\n* Understands and agrees to comply with planned study procedures.\n* Has laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined by polymerase chain reaction (PCR) available at KAUH.\n\nExclusion Criteria:\n\n* Patients with pneumonia or severe illness requiring admission to ICU.\n* Severe chronic kidney disease (i.e. estimated glomerular filtration rate (eGFR) \\< 30) or end stage renal disease requiring dialysis\n* Sever chronic liver disease (Alanine transaminase/aspartate transaminase (ALT/AST) \\> 5 times the upper limit of normal).\n* Pregnancy or breast feeding.\n* Anticipated transfer to another hospital which is not a study site within 72 hours.\n* Allergy to any study medication.'}, 'identificationModule': {'nctId': 'NCT04401202', 'briefTitle': 'Nigella Sativa in COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'King Abdulaziz University'}, 'officialTitle': 'Effects of Nigella Sativa as a Treatment of Patients With Upper Respiratory Tract Infection Caused by SARS-coronavirus-2: a Prospective, Randomized, Open-label, Controlled Clinical Study', 'orgStudyIdInfo': {'id': '266-20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NSO', 'description': 'Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days', 'interventionNames': ['Dietary Supplement: Nigella sativa oil']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Standard of care'}], 'interventions': [{'name': 'Nigella sativa oil', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days', 'armGroupLabels': ['NSO']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21589', 'city': 'Jeddah', 'country': 'Saudi Arabia', 'facility': 'King Abdulaziz University Hospital', 'geoPoint': {'lat': 21.49012, 'lon': 39.18624}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Abdulaziz University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Dr Abdulrahman E. Koshak', 'investigatorAffiliation': 'King Abdulaziz University'}}}}