Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 11:48 PM
Study NCT ID:
NCT00858494
Status:
COMPLETED
Last Update Posted:
2018-07-26
First Post:
2009-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Homeopathic Cold Medicine for Children
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'uncjat@uw.edu', 'phone': '206-616-1206', 'title': 'James A Taylor', 'organization': 'University of Washington'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'up to 10 days after the index visit', 'description': 'Parents noted any adverse events after each dose of study medication in study logs that were returned to the research staff. Data on any adverse event were based on information in study logs returned in 37 of 49 participants. Parents were instructed to call research team if a serious adverse event occurred; data on all 49 participants presented.', 'eventGroups': [{'id': 'EG000', 'title': 'Homeopathic Cold Remedy', 'description': "Hyland's Cold 'n Cough for Kids, 5 ml by mouth up to 6 times per day as needed for cold symptoms", 'otherNumAtRisk': 37, 'otherNumAffected': 2, 'seriousNumAtRisk': 49, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'diarrhea', 'notes': 'Parent noted diarrhea after 2 doses of study medication (occurred in 1 child)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'excessive gas', 'notes': 'parent noted excessive gas after 1 dose of study medication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Relief of Upper Respiratory Tract Infection (URI) Symptoms (Cough, Runny Nose, Nasal Congestion, Sneezing)1 Hour After Dose of Homeopathic Remedy.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}, {'units': 'doses', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Homeopathic Cold Remedy', 'description': "Hyland's Cold 'n Cough for Kids, 5 ml by mouth up to 6 times per day as needed for cold symptoms"}], 'classes': [{'title': 'Runny Nose (treated with 135 doses)', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}]}]}, {'title': 'Cough (treated with 154 doses)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Nasal congestion (treated with 152 doses)', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}]}]}, {'title': 'Sneezing (treated with 81 doses)', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 10 days from index visit', 'description': 'For each dose of study medication, parents indicated which of the symptoms were present (runny nose, cough, nasal congestion, sneezing). Parents rated change in each symptom present one hour after a dose of study medication for up to 6 doses in study logs. Responses were dichotomized as at least some improvement or better (improvement) vs. no improvement or worse. The outcome measure is number of times that improvement in a specific symptom was noted after a dose of the homeopathic remedy. Completed study logs were received from 37 of 49 enrolled participants.', 'unitOfMeasure': 'doses', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'doses', 'denomUnitsSelected': 'doses', 'populationDescription': 'Some symptoms were not present at each dose of the homeopathic remedy. Number of doses at which symptom was present: runny nose: 135, nasal congestion: 152, cough: 154, sneezing 81. The outcome is number of times improvement in each symptom was noted.'}, {'type': 'SECONDARY', 'title': 'Parental Report of an Adverse Event After a Dose of Study Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}, {'units': 'doses', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Homeopathic Cold Remedy', 'description': "Hyland's Cold 'n Cough for Kids, 5 ml by mouth up to 6 times per day as needed for cold symptoms"}], 'classes': [{'title': 'any adverse event', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'diarrhea', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'excessive gas', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'data collected after doses occurring up to 10 days after index visit', 'description': 'After each dose of study medication parents reported the presence of any adverse events', 'unitOfMeasure': 'doses', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'doses', 'denomUnitsSelected': 'doses', 'populationDescription': "Study logs were returned in 37 of 49 enrolled participants. After each dose of study medication, the participant's parent indicated in the study log whether any adverse events were noted."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Homeopathic Cold Remedy', 'description': "Hyland's Cold 'n Cough for Kids, 5 ml by mouth up to 6 times per day as needed for cold symptoms"}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '2 participants dropped out before giving study medication. Symptoms resolved without a dose in 2.', 'groupId': 'FG000', 'numSubjects': '45'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'Children diagnosed with an upper respiratory tract infection (URI) at a pediatric clinic were recruited for the study from March to September 2009', 'preAssignmentDetails': 'one participant who was enrolled had a positive test for streptococcal pharyngitis at the index visit and was prescribed antibiotics. This participant thus became ineligible.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Homeopathic Cold Remedy', 'description': "Hyland's Cold 'n Cough for Kids, 5 ml by mouth up to 6 times per day as needed for cold symptoms"}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '49', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'spread': '1.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-23', 'studyFirstSubmitDate': '2009-03-05', 'resultsFirstSubmitDate': '2010-12-27', 'studyFirstSubmitQcDate': '2009-03-06', 'lastUpdatePostDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-03-01', 'studyFirstPostDateStruct': {'date': '2009-03-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relief of Upper Respiratory Tract Infection (URI) Symptoms (Cough, Runny Nose, Nasal Congestion, Sneezing)1 Hour After Dose of Homeopathic Remedy.', 'timeFrame': 'up to 10 days from index visit', 'description': 'For each dose of study medication, parents indicated which of the symptoms were present (runny nose, cough, nasal congestion, sneezing). Parents rated change in each symptom present one hour after a dose of study medication for up to 6 doses in study logs. Responses were dichotomized as at least some improvement or better (improvement) vs. no improvement or worse. The outcome measure is number of times that improvement in a specific symptom was noted after a dose of the homeopathic remedy. Completed study logs were received from 37 of 49 enrolled participants.'}], 'secondaryOutcomes': [{'measure': 'Parental Report of an Adverse Event After a Dose of Study Medication', 'timeFrame': 'data collected after doses occurring up to 10 days after index visit', 'description': 'After each dose of study medication parents reported the presence of any adverse events'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['upper respiratory tract infection', 'children', 'homeopathic'], 'conditions': ['Upper Respiratory Tract Infection']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if a commercially available homeopathic cold remedy for children is effective in providing relief from cold symptoms in children 2-5 years old. It is postulated that children will have relief of symptoms after receiving a dose of the cold remedy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '59 Months', 'minimumAge': '24 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children 24-59 months old\n* Cold/cough symptoms of \\<7 days duration\n* Diagnosed with upper respiratory tract infection by physician or nurse practitioner\n* Parent who speaks and reads English\n\nExclusion Criteria:\n\n* Use of chronic medication other than multivitamins\n* History of asthma\n* Medication other than acetaminophen or ibuprofen\n* Use of homeopathic remedy within preceding 30 days\n* Only 1 participant per family'}, 'identificationModule': {'nctId': 'NCT00858494', 'briefTitle': 'Homeopathic Cold Medicine for Children', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Homeopathic Cold Medicine for Children', 'orgStudyIdInfo': {'id': '35537'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'homeopathic cold remedy', 'interventionNames': ["Drug: Hyland's Cold 'n Cough 4 Kids"]}], 'interventions': [{'name': "Hyland's Cold 'n Cough 4 Kids", 'type': 'DRUG', 'description': 'Liquid homeopathic cold remedy, 5 ml by mouth every 4 hours as needed for relief of cold symptoms for up to 10 days', 'armGroupLabels': ['homeopathic cold remedy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington Medical Center-Roosevelt Pediatric Care Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'James A Taylor, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'Standard Homeopathic Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'James Taylor', 'investigatorAffiliation': 'University of Washington'}}}}