Ignite Creation Date:
2025-12-24 @ 2:41 PM
Ignite Modification Date:
2026-02-02 @ 7:42 AM
Study NCT ID:
NCT04410159
Status:
COMPLETED
Last Update Posted:
2020-07-21
First Post:
2020-05-27
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Povidone-Iodine Vs Essential Oil Vs Tap Water Gargling For COVID-19 Patients
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': 'D011206', 'term': 'Povidone-Iodine'}, {'id': 'D009822', 'term': 'Oils, Volatile'}, {'id': 'C057473', 'term': 'Listerine'}], 'ancestors': [{'id': 'D007466', 'term': 'Iodophors'}, {'id': 'D017613', 'term': 'Iodine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D011145', 'term': 'Polyvinyls'}, {'id': 'D014753', 'term': 'Vinyl Compounds'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011205', 'term': 'Povidone'}, {'id': 'D011760', 'term': 'Pyrrolidinones'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010969', 'term': 'Plastics'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'drnurul@usim.edu.my', 'phone': '+603 42892400', 'title': 'NURUL AZMAWATI MOHAMED', 'phoneExt': '2417', 'organization': 'UNIVERSITI SAINS ISLAM MALAYSIA'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Inadequate budget for laboratory test lead to small numbers of subjects analyzed'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected from day 1 of intervention until day 14', 'description': 'Similar to clinicaltrial.gov', 'eventGroups': [{'id': 'EG000', 'title': 'Povidone-iodine', 'description': 'gargle with povidone-iodine 10mL, 30 seconds, 3 times per day, 7 days\n\nPovidone-Iodine: Gargle', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Essential Oils', 'description': 'gargle with essential oils 20mL, 30 seconds, 3 times per day, 7 days\n\nEssential oils: Gargle', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Tap Water', 'description': 'gargle with tap water 100 mL, 30 seconds, 3 times per day, 7 days\n\nTap water: Gargle', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Control', 'description': 'This group will receive the standard treatment protocol without any additional intervention', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Early Viral Clearance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Povidone-iodine', 'description': 'gargle with povidone-iodine 10mL, 30 seconds, 3 times per day, 7 days\n\nPovidone-Iodine: Gargle'}, {'id': 'OG001', 'title': 'Essential Oils', 'description': 'gargle with essential oils 20mL, 30 seconds, 3 times per day, 7 days\n\nEssential oils: Gargle'}, {'id': 'OG002', 'title': 'Tap Water', 'description': 'gargle with tap water 100 mL, 30 seconds, 3 times per day, 7 days\n\nTap water: Gargle'}, {'id': 'OG003', 'title': 'Control', 'description': 'This group will receive the standard treatment protocol without any additional intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 6', 'description': 'Viral clearance is defined as two negative RT-PCR (of swabs from oropharynx and nasopharynx) results at least 24 hours apart', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Negative RT-PCR Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Povidone-iodine', 'description': 'gargle with povidone-iodine 10mL, 30 seconds, 3 times per day, 7 days\n\nPovidone-Iodine: Gargle'}, {'id': 'OG001', 'title': 'Essential Oils', 'description': 'gargle with essential oils 20mL, 30 seconds, 3 times per day, 7 days\n\nEssential oils: Gargle'}, {'id': 'OG002', 'title': 'Tap Water', 'description': 'gargle with tap water 100 mL, 30 seconds, 3 times per day, 7 days\n\nTap water: Gargle'}, {'id': 'OG003', 'title': 'Control', 'description': 'This group will receive the standard treatment protocol without any additional intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 12', 'description': 'RT-PCR (swabs from oropharynx and nasopharynx) taken at day 12', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients That Progress to More Severe Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Povidone-iodine', 'description': 'gargle with povidone-iodine 10mL, 30 seconds, 3 times per day, 7 days\n\nPovidone-Iodine: Gargle'}, {'id': 'OG001', 'title': 'Essential Oils', 'description': 'gargle with essential oils 20mL, 30 seconds, 3 times per day, 7 days\n\nEssential oils: Gargle'}, {'id': 'OG002', 'title': 'Tap Water', 'description': 'gargle with tap water 100 mL, 30 seconds, 3 times per day, 7 days\n\nTap water: Gargle'}, {'id': 'OG003', 'title': 'Control', 'description': 'This group will receive the standard treatment protocol without any additional intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 12', 'description': 'Presence of signs and symptoms of more severe COVID19 Based symptoms diary and clinical evaluation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Abnormal Radiological Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Povidone-iodine', 'description': 'gargle with povidone-iodine 10mL, 30 seconds, 3 times per day, 7 days\n\nPovidone-Iodine: Gargle'}, {'id': 'OG001', 'title': 'Essential Oils', 'description': 'gargle with essential oils 20mL, 30 seconds, 3 times per day, 7 days\n\nEssential oils: Gargle'}, {'id': 'OG002', 'title': 'Tap Water', 'description': 'gargle with tap water 100 mL, 30 seconds, 3 times per day, 7 days\n\nTap water: Gargle'}, {'id': 'OG003', 'title': 'Control', 'description': 'This group will receive the standard treatment protocol without any additional intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0-14', 'description': 'abnormal chest x-ray or CT scan', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Abnormal Laboratory Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Povidone-iodine', 'description': 'gargle with povidone-iodine 10mL, 30 seconds, 3 times per day, 7 days\n\nPovidone-Iodine: Gargle'}, {'id': 'OG001', 'title': 'Essential Oils', 'description': 'gargle with essential oils 20mL, 30 seconds, 3 times per day, 7 days\n\nEssential oils: Gargle'}, {'id': 'OG002', 'title': 'Tap Water', 'description': 'gargle with tap water 100 mL, 30 seconds, 3 times per day, 7 days\n\nTap water: Gargle'}, {'id': 'OG003', 'title': 'Control', 'description': 'This group will receive the standard treatment protocol without any additional intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0-14', 'description': 'Abnormal absolute lymphocytic count Abnormal C-reactive protein', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Povidone-iodine', 'description': 'gargle with povidone-iodine 10mL, 30 seconds, 3 times per day, 7 days\n\nPovidone-Iodine: Gargle'}, {'id': 'FG001', 'title': 'Essential Oils', 'description': 'gargle with essential oils 20mL, 30 seconds, 3 times per day, 7 days\n\nEssential oils: Gargle'}, {'id': 'FG002', 'title': 'Tap Water', 'description': 'gargle with tap water 100 mL, 30 seconds, 3 times per day, 7 days\n\nTap water: Gargle'}, {'id': 'FG003', 'title': 'Control', 'description': 'This group will receive the standard treatment protocol without any additional intervention'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'All patients were recruited 2 to 3 days after date of diagnosis (nasophryngeal swab postive for SARS-C0V-2. All patients were asymptomatic and admitted to the hospital for observation', 'preAssignmentDetails': 'No significant event occurred after enrollment'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Povidone-iodine', 'description': 'gargle with povidone-iodine 10mL, 30 seconds, 3 times per day, 7 days\n\nPovidone-Iodine: Gargle'}, {'id': 'BG001', 'title': 'Essential Oils', 'description': 'gargle with essential oils 20mL, 30 seconds, 3 times per day, 7 days\n\nEssential oils: Gargle'}, {'id': 'BG002', 'title': 'Tap Water', 'description': 'gargle with tap water 100 mL, 30 seconds, 3 times per day, 7 days\n\nTap water: Gargle'}, {'id': 'BG003', 'title': 'Control', 'description': 'This group received the standard treatment protocol without any additional intervention'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.4', 'spread': '7.44', 'groupId': 'BG000'}, {'value': '34.4', 'spread': '12.50', 'groupId': 'BG001'}, {'value': '30.8', 'spread': '3.77', 'groupId': 'BG002'}, {'value': '24.8', 'spread': '2.68', 'groupId': 'BG003'}, {'value': '30.6', 'spread': '7.91', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Malaysia', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-05-01', 'size': 125630, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2020-07-17T22:26', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '4 arms\n\n1. Gargle with povidone-iodine\n2. Gargle with essential oils\n3. Gargle with tap water\n4. Control'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-07-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-17', 'studyFirstSubmitDate': '2020-05-27', 'resultsFirstSubmitDate': '2020-07-08', 'studyFirstSubmitQcDate': '2020-05-28', 'lastUpdatePostDateStruct': {'date': '2020-07-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-07-17', 'studyFirstPostDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Early Viral Clearance', 'timeFrame': 'Day 6', 'description': 'Viral clearance is defined as two negative RT-PCR (of swabs from oropharynx and nasopharynx) results at least 24 hours apart'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Negative RT-PCR Results', 'timeFrame': 'Day 12', 'description': 'RT-PCR (swabs from oropharynx and nasopharynx) taken at day 12'}, {'measure': 'Number of Patients That Progress to More Severe Disease', 'timeFrame': 'Day 12', 'description': 'Presence of signs and symptoms of more severe COVID19 Based symptoms diary and clinical evaluation'}, {'measure': 'Number of Patients With Abnormal Radiological Findings', 'timeFrame': 'Day 0-14', 'description': 'abnormal chest x-ray or CT scan'}, {'measure': 'Number of Patients With Abnormal Laboratory Findings', 'timeFrame': 'Day 0-14', 'description': 'Abnormal absolute lymphocytic count Abnormal C-reactive protein'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gargle', 'povidone-iodine', 'essential oils', 'tap water'], 'conditions': ['COVID-19']}, 'referencesModule': {'references': [{'pmid': '29633177', 'type': 'BACKGROUND', 'citation': 'Eggers M, Koburger-Janssen T, Eickmann M, Zorn J. In Vitro Bactericidal and Virucidal Efficacy of Povidone-Iodine Gargle/Mouthwash Against Respiratory and Oral Tract Pathogens. Infect Dis Ther. 2018 Jun;7(2):249-259. doi: 10.1007/s40121-018-0200-7. Epub 2018 Apr 9.'}, {'pmid': '31414403', 'type': 'BACKGROUND', 'citation': 'Eggers M. Infectious Disease Management and Control with Povidone Iodine. Infect Dis Ther. 2019 Dec;8(4):581-593. doi: 10.1007/s40121-019-00260-x. Epub 2019 Aug 14.'}, {'pmid': '7614202', 'type': 'BACKGROUND', 'citation': 'Dennison DK, Meredith GM, Shillitoe EJ, Caffesse RG. The antiviral spectrum of Listerine antiseptic. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1995 Apr;79(4):442-8. doi: 10.1016/s1079-2104(05)80124-6.'}, {'pmid': '16242593', 'type': 'BACKGROUND', 'citation': 'Satomura K, Kitamura T, Kawamura T, Shimbo T, Watanabe M, Kamei M, Takano Y, Tamakoshi A; Great Cold Investigators-I. Prevention of upper respiratory tract infections by gargling: a randomized trial. Am J Prev Med. 2005 Nov;29(4):302-7. doi: 10.1016/j.amepre.2005.06.013.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the ability of regular gargling to eliminate severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in the throat and nasopharynx. This 4 arms interventional study compares the effect of gargling using povidone-iodine, essential oils- based, tap water with control (no intervention) among Stage 1 coronavirus disease-2019 (COVID-19) patients.\n\nFindings from this study will provide new insight into the importance of gargling in the treatment and prevention of COVID-19.', 'detailedDescription': 'Experimental plan\n\nAfter consent is taken, all groups will be briefed regarding the study protocol separately.\n\n* Group A will be briefed on the correct procedures of gargling with Betadine®. The participants will be instructed to take 10ml of povidone-iodine (PVP-I), tilt their heads backward and gargle for 30 seconds, three times per day for 7 days\n* Group B will be briefed on the correct technique of gargling with Listerine®. The participants will be instructed to take 20ml of essential oils, tilt their heads backward and gargle for 30 seconds, three times per day for 7 days\n* Group C will be briefed on the correct technique of gargling with hydrogen peroxide. The participants will be instructed to take 10ml of hydrogen peroxide, tilt their heads backward and gargle for 30 seconds, three times per day for 7 days\n* Group D will be briefed about the involvement in this study. They will be managed according to the standard protocol of the hospital with no additional intervention.\n\nMonitoring\n\n1. Oropharyngeal and nasopharyngeal swabs will be taken on day 4, 6 of intervention, and day 12 post-intervention. The swabs will be subjected to detection of SARS-CoV-2 by real-time reverse transcriptase-polymerase chain reaction (rt RT-PCR).\n2. Patients will be given a chart for them to record their gargling practice and symptoms (if any) during the intervention period ( 7 days)\n3. Clinical data collection sheet will be provided to attending clinicians. The required information includes demographic data, daily vital signs, serial absolute lymphocytic count, LDH, chest radiograph, and symptoms. Clinical monitoring will be done until day 14 of the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. adult aged 18 years and above\n2. able to understand instructions\n3. Stage 1 COVID-19\n4. \\< 5 days of illness or diagnosis\n\nExclusion Criteria:\n\n1. Less than 18 years old\n2. Unable to understand instructions\n3. Stage 2 \\& 3 COVID-19\n4. Respiratory symptoms or fever on admission\n5. Abnormal chest radiograph or computed tomography (CT) findings on admission'}, 'identificationModule': {'nctId': 'NCT04410159', 'acronym': 'GARGLES', 'briefTitle': 'Povidone-Iodine Vs Essential Oil Vs Tap Water Gargling For COVID-19 Patients', 'organization': {'class': 'OTHER', 'fullName': 'Universiti Sains Islam Malaysia'}, 'officialTitle': 'A Pilot, Open-Labelled, Randomised Controlled Trial Of Povidone-Iodine Vs Essential Oil And Tap Water Gargling For COVID-19 Patients', 'orgStudyIdInfo': {'id': 'USIMalaysia'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Povidone-iodine', 'description': 'gargle with povidone-iodine 10mL, 30 seconds, 3 times per day, 7 days', 'interventionNames': ['Drug: Povidone-Iodine']}, {'type': 'EXPERIMENTAL', 'label': 'Essential Oils', 'description': 'gargle with essential oils 20mL, 30 seconds, 3 times per day, 7 days', 'interventionNames': ['Drug: Essential oils']}, {'type': 'EXPERIMENTAL', 'label': 'Tap water', 'description': 'gargle with tap water 100 mL, 30 seconds, 3 times per day, 7 days', 'interventionNames': ['Other: Tap water']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'This group will receive the standard treatment protocol without any additional intervention'}], 'interventions': [{'name': 'Povidone-Iodine', 'type': 'DRUG', 'otherNames': ['Betadine'], 'description': 'Gargle', 'armGroupLabels': ['Povidone-iodine']}, {'name': 'Essential oils', 'type': 'DRUG', 'otherNames': ['Listerine'], 'description': 'Gargle', 'armGroupLabels': ['Essential Oils']}, {'name': 'Tap water', 'type': 'OTHER', 'description': 'Gargle', 'armGroupLabels': ['Tap water']}]}, 'contactsLocationsModule': {'locations': [{'zip': '56000', 'city': 'Bandar Tun Razak', 'state': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': 'Universiti Kebangsaan Malaysia Medical Centre'}], 'overallOfficials': [{'name': 'NURUL A MOHAMED', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universiti Sains Islam Malaysia'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'September to December 2020', 'ipdSharing': 'YES', 'description': 'The participant data from the final research dataset used in the published manuscript will be shared upon reasonable request. The protocol and data analysis will be shared in clinicaltrial', 'accessCriteria': 'email to drnurul@usim.edu.my'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universiti Sains Islam Malaysia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universiti Kebangsaan Malaysia Medical Centre', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'NURUL AZMAWATI MOHAMED', 'investigatorAffiliation': 'Universiti Sains Islam Malaysia'}}}}