Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2026-02-22 @ 6:43 PM
Study NCT ID:
NCT01257503
Status:
COMPLETED
Last Update Posted:
2015-01-14
First Post:
2010-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Homeopathic Cold Remedy for Children Study
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': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Data were collected during the study period and at the follow-up phone call scheduled 7-10 days after enrollment', 'description': 'Parents were asked to record any side effects after each dose of study medications. Parents also asked about side effects during follow-up phone call.', 'eventGroups': [{'id': 'EG000', 'title': 'Homeopathic Cold Remedy', 'description': "5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms\n\nHyland's Cold 'n Cough 4 kids: 5 ml PO q4h prn cold symptoms", 'otherNumAtRisk': 133, 'otherNumAffected': 0, 'seriousNumAtRisk': 133, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': '5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms\n\nplacebo: liquid made to look like the active homeopathic remedy', 'otherNumAtRisk': 130, 'otherNumAffected': 0, 'seriousNumAtRisk': 130, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Severity of Cold Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}, {'units': 'doses', 'counts': [{'value': '502', 'groupId': 'OG000'}, {'value': '480', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Homeopathic Cold Remedy', 'description': "5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms\n\nHyland's Cold 'n Cough 4 kids: 5 ml PO q4h prn cold symptoms"}, {'id': 'OG001', 'title': 'Placebo', 'description': '5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms\n\nplacebo: liquid made to look like the active homeopathic remedy'}], 'classes': [{'title': 'runny nose (n=433, 386)', 'categories': [{'measurements': [{'value': '3.7', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'sneeze (n=219, 237)', 'categories': [{'measurements': [{'value': '3.9', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'cough (n=399, 373)', 'categories': [{'measurements': [{'value': '3.8', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'congestion (n=409, 436)', 'categories': [{'measurements': [{'value': '3.8', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.86', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'change in runny nose', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'generalized estimating equations used to account for multiple doses in same participant', 'testedNonInferiority': False}, {'pValue': '.89', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'change in sneeze', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'generalized estimating equations used to account for multiple doses in single participant', 'testedNonInferiority': False}, {'pValue': '.45', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'change in cough', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'generalized estimating equations used to account for multiple doses in single participant', 'testedNonInferiority': False}, {'pValue': '.82', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'change in congestion', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'generalized estimating equations used to account for multiple doses in single participant', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Parents assessed change in symptom 1 hour after a dose of study medication', 'description': 'Parents measured change in runny nose, cough, nasal congestion and sneezing severity one hour after administering a dose of study medication up to the first 10 doses of study medication. Change in symptom rated from 0 to 6, with 0 indicative of the symptom being much worse and 6 indicative of the symptom being much improved. The unit of analysis for each outcome was doses of medication. Each participant could contribute data on 0 - 10 doses.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'doses', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Data are from logbooks returned by participants. For each participant, data on response to up to 10 doses were collected. Not every symptom was present at each dose. Change in runny nose assessed after 819 doses, sneeze 456 doses, cough 772 doses, congestion 845. For category title, first n= homeopathic cold remedy, second n= placebo.'}, {'type': 'SECONDARY', 'title': 'Change in Non-specific Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}, {'units': 'doses', 'counts': [{'value': '502', 'groupId': 'OG000'}, {'value': '480', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Homeopathic Cold Remedy', 'description': "5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms\n\nHyland's Cold 'n Cough 4 kids: 5 ml PO q4h prn cold symptoms"}, {'id': 'OG001', 'title': 'Placebo', 'description': '5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms\n\nplacebo: liquid made to look like the active homeopathic remedy'}], 'classes': [{'title': 'irritability (n= 272, 238)', 'categories': [{'measurements': [{'value': '3.6', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'lethargy (n=213, 201)', 'categories': [{'measurements': [{'value': '3.6', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'fussiness (n=262, 239)', 'categories': [{'measurements': [{'value': '3.6', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'appetite (n=312, 306)', 'categories': [{'measurements': [{'value': '3.6', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '1.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.61', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'change in irritability', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Generalized estimating equations used to account for multiple doses in single participant.', 'testedNonInferiority': False}, {'pValue': '.97', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'change in lethargy', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Generalized estimating equations used to account for multiple doses in single participant.', 'testedNonInferiority': False}, {'pValue': '.79', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'change in fussiness', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Generalized estimating equations used to account for multiple doses in single participant.', 'testedNonInferiority': False}, {'pValue': '.81', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'change in appetite', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Generalized estimating equations used to account for multiple doses in single participant.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Parents assessed change in symptom 1 hour after dose of study medication', 'description': 'Parents measured change in severity of irritability, lethargy, fussiness, and appetite one hour after administering a dose of study medication up to the first 10 doses of study medication. Change in symptom rated from 0 to 6, with 0 indicative of the symptom being much worse and 6 indicative of the symptom being much improved. The unit of analysis for each outcome was doses of medication. Each participant could contribute data on 0 - 10 doses.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'doses', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Data are from logbooks returned by participants. For each participant, data on response to up to 10 doses were collected. Not every symptom was present at each dose. Change in irritability assessed after 510 doses, lethargy 414, fussiness 501, appetite 618. For category title, first n= homeopathic cold remedy, second n= placebo.'}, {'type': 'SECONDARY', 'title': 'Functional Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Homeopathic Cold Remedy', 'description': "5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms\n\nHyland's Cold 'n Cough 4 kids: 5 ml PO q4h prn cold symptoms"}, {'id': 'OG001', 'title': 'Placebo', 'description': '5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms\n\nplacebo: liquid made to look like the active homeopathic remedy'}], 'classes': [{'title': 'functional status day 1 (n=68, 77)', 'categories': [{'measurements': [{'value': '11.0', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '10.4', 'spread': '3.1', 'groupId': 'OG001'}]}]}, {'title': 'functional status day 2 (n=72, 70)', 'categories': [{'measurements': [{'value': '11.7', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '11.8', 'spread': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'functional status day 3 (n= 62, 68)', 'categories': [{'measurements': [{'value': '12.7', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '12.5', 'spread': '3.0', 'groupId': 'OG001'}]}]}, {'title': 'functional status at follow-up (n=123, 117)', 'categories': [{'measurements': [{'value': '14.2', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '13.7', 'spread': '2.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.16', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'functional status day 1', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '.70', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'functional status day 2', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '.77', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'functional status day 3', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '.41', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'functional status at 7-10 day follow-up', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '10 days', 'description': 'Change in functional status of child during the 7-10 days after the index visit for an upper respiratory tract infection. Parents rated 5 activities (vigorous activity, activities that require concentration, activities with family or friends, appetite and sleep) daily for 3 days in their child and again at the 7-10 day follow-up. Functional status scores range from 0 to 15, with higher scores indicative of better functional status.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed follow-up and had valid data for functional outcome. Data on functional status analyzed on days 1-3 for participants who returned symptom diaries including 145 on day 1, 142 on day 2 and 130 on day 3. For category title, first n= homeopathic cold remedy, second n= placebo.'}, {'type': 'SECONDARY', 'title': 'Health Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Homeopathic Cold Remedy', 'description': "5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms\n\nHyland's Cold 'n Cough 4 kids: 5 ml PO q4h prn cold symptoms"}, {'id': 'OG001', 'title': 'Placebo', 'description': '5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms\n\nplacebo: liquid made to look like the active homeopathic remedy'}], 'classes': [{'title': 'health status day 1 (n=75, 77)', 'categories': [{'measurements': [{'value': '4.4', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '4.9', 'spread': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'health status day 2 (n=72,70)', 'categories': [{'measurements': [{'value': '3.8', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'health status day 3 (n=63, 69)', 'categories': [{'measurements': [{'value': '3.2', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'health status at follow-up (n=125, 117)', 'categories': [{'measurements': [{'value': '2.5', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '1.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.10', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'health status day 1', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '.28', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'health status day 2', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '.26', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'health status day 3', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '.88', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'health status at follow-up', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '10 days', 'description': 'Change in health status of child during the 7-10 days after the index visit for an upper respiratory tract infection. Parents rated health status on 1-10 scale with 1 indicating perfect health and 10 indicating very sick. Health status rated on first 3 days of study and again at the 7-10 day follow-up', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Health status on those with follow-up data and a valid score for health status. Health status also assessed in participants who returned symptom diaries including 152 on day 1, 142 on day 2 and 132 on day 3. For category title, first n= homeopathic cold remedy, second n= placebo.'}, {'type': 'SECONDARY', 'title': 'Overall Symptom Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Homeopathic Cold Remedy', 'description': "5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms\n\nHyland's Cold 'n Cough 4 kids: 5 ml PO q4h prn cold symptoms"}, {'id': 'OG001', 'title': 'Placebo', 'description': '5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms\n\nplacebo: liquid made to look like the active homeopathic remedy'}], 'classes': [{'title': 'day 1 assessment 1 (n=73, 80)', 'categories': [{'measurements': [{'value': '4.6', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '2.3', 'groupId': 'OG001'}]}]}, {'title': 'day 1 assessment 2 (n=72, 76)', 'categories': [{'measurements': [{'value': '4.2', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'day 2 assessment 1 (n=73, 73)', 'categories': [{'measurements': [{'value': '3.7', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'day 2 assessment 2 (n=69, 69)', 'categories': [{'measurements': [{'value': '3.4', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '2.2', 'groupId': 'OG001'}]}]}, {'title': 'day 3 assessment 1 (n=68, 68)', 'categories': [{'measurements': [{'value': '3.0', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '2.3', 'groupId': 'OG001'}]}]}, {'title': 'day 3 assessment 2 (n= 60, 66)', 'categories': [{'measurements': [{'value': '2.8', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '2.3', 'groupId': 'OG001'}]}]}, {'title': 'follow-up (n= 123, 117)', 'categories': [{'measurements': [{'value': '2.4', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '2.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.02', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'cold score day 1 assessment 1', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '.01', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'cold score day 1 assessment 2', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '.25', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'day 2 assessment 1', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '.15', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'cold score day 2 assessment 2', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '.88', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'cold score day 3 assessment 1', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '.35', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'cold score day 3 assessment 2', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '.36', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'cold score at 7-10 day follow-up', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '10 days', 'description': 'Change in cold symptoms of child during the 7-10 days after the index visit for an upper respiratory tract infection. Parents assessed severity of runny nose, cough, sneeze and congestion in their child using a 0-3 scale for each symptom, 0=none to 3= severe. Cold score is sum of scores for each symptom. Parents assessed cold score twice daily on study days 1-3 and at the 7-10 day follow-up', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data analyzed on participant who completed 7-10 day follow-up and had valid cold scores. Data also analyzed twice daily on those participants who returned symptom diaries including: day 1 (153, 148), day 2 (146,138), and day 3 (136, 126). For category title, first n= homeopathic cold remedy, second n= placebo.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Homeopathic Cold Remedy', 'description': "5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms\n\nHyland's Cold 'n Cough 4 kids: 5 ml PO q4h prn cold symptoms"}, {'id': 'FG001', 'title': 'Placebo', 'description': '5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms\n\nplacebo: liquid made to look like the active homeopathic remedy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '133'}, {'groupId': 'FG001', 'numSubjects': '130'}]}, {'type': 'Returned Symptom Diaries', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '83'}]}, {'type': 'Returned Dosage Logbooks', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '80'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed defined as participants who completed telephone follow-up at end of study period', 'groupId': 'FG000', 'numSubjects': '125'}, {'comment': 'Completed defined as participants who completed telephone follow-up at end of study period', 'groupId': 'FG001', 'numSubjects': '119'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Over 5 years old at enrollment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'strep culture positive at enrollment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '261', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Homeopathic Cold Remedy', 'description': "5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms\n\nHyland's Cold 'n Cough 4 kids: 5 ml PO q4h prn cold symptoms"}, {'id': 'BG001', 'title': 'Placebo', 'description': '5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms\n\nplacebo: liquid made to look like the active homeopathic remedy'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '132', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '261', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'exact age information missing on 2 participants in placebo group, noted to be 2-5 years old', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'spread': '1.1', 'groupId': 'BG000'}, {'value': '3.5', 'spread': '1.1', 'groupId': 'BG001'}, {'value': '3.5', 'spread': '1.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Gender information missing on 1 participant randomized to the homeopathic cold remedy group', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '132', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '261', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'baseline cold symptom score', 'classes': [{'categories': [{'measurements': [{'value': '5.4', 'spread': '1.8', 'groupId': 'BG000'}, {'value': '5.2', 'spread': '1.8', 'groupId': 'BG001'}, {'value': '5.3', 'spread': '1.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'sum of scores for runny nose severity, sneeze severity, cough severity and congestion severity rated by parent at study entry. For each symptom, possible scores range from 0 to 3, with 3 indicating most severe. Baseline cold score missing on 1 participant in the homeopathic cold remedy group', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Eligible patients enrolled. Age data were analyzed on 127 participants in the placebo group since exact data were missing for 2 participants'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 263}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-31', 'studyFirstSubmitDate': '2010-12-08', 'resultsFirstSubmitDate': '2014-12-09', 'studyFirstSubmitQcDate': '2010-12-08', 'lastUpdatePostDateStruct': {'date': '2015-01-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-12-18', 'studyFirstPostDateStruct': {'date': '2010-12-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-01-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Severity of Cold Symptoms', 'timeFrame': 'Parents assessed change in symptom 1 hour after a dose of study medication', 'description': 'Parents measured change in runny nose, cough, nasal congestion and sneezing severity one hour after administering a dose of study medication up to the first 10 doses of study medication. Change in symptom rated from 0 to 6, with 0 indicative of the symptom being much worse and 6 indicative of the symptom being much improved. The unit of analysis for each outcome was doses of medication. Each participant could contribute data on 0 - 10 doses.'}], 'secondaryOutcomes': [{'measure': 'Change in Non-specific Symptoms', 'timeFrame': 'Parents assessed change in symptom 1 hour after dose of study medication', 'description': 'Parents measured change in severity of irritability, lethargy, fussiness, and appetite one hour after administering a dose of study medication up to the first 10 doses of study medication. Change in symptom rated from 0 to 6, with 0 indicative of the symptom being much worse and 6 indicative of the symptom being much improved. The unit of analysis for each outcome was doses of medication. Each participant could contribute data on 0 - 10 doses.'}, {'measure': 'Functional Status', 'timeFrame': '10 days', 'description': 'Change in functional status of child during the 7-10 days after the index visit for an upper respiratory tract infection. Parents rated 5 activities (vigorous activity, activities that require concentration, activities with family or friends, appetite and sleep) daily for 3 days in their child and again at the 7-10 day follow-up. Functional status scores range from 0 to 15, with higher scores indicative of better functional status.'}, {'measure': 'Health Status', 'timeFrame': '10 days', 'description': 'Change in health status of child during the 7-10 days after the index visit for an upper respiratory tract infection. Parents rated health status on 1-10 scale with 1 indicating perfect health and 10 indicating very sick. Health status rated on first 3 days of study and again at the 7-10 day follow-up'}, {'measure': 'Overall Symptom Severity', 'timeFrame': '10 days', 'description': 'Change in cold symptoms of child during the 7-10 days after the index visit for an upper respiratory tract infection. Parents assessed severity of runny nose, cough, sneeze and congestion in their child using a 0-3 scale for each symptom, 0=none to 3= severe. Cold score is sum of scores for each symptom. Parents assessed cold score twice daily on study days 1-3 and at the 7-10 day follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['children', 'upper respiratory tract infections', 'homeopathy'], 'conditions': ['Upper Respiratory Tract Infections']}, 'descriptionModule': {'briefSummary': "A randomized controlled trial of a commercially available homeopathic cold remedy will be conducted. A total of 400 children, 2-5 years old, diagnosed with an upper respiratory tract infection will be randomized to receive either the homeopathic remedy or placebo. Parents of study children will administer 5 ml of the study medication up to 6 times per day as needed to treat cold symptoms. One hour after giving a dose the parent will rate change in symptoms (for up to the first 10 doses). In addition, parents will rate their child's overall symptom severity and functional status over the first 3 days of the cold. It is postulated that children receiving the active homeopathic remedy will have better symptom relief and that their symptom severity and functional status will improve more rapidly than those receiving placebo."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnosis of upper respiratory tract infection\n* duration of symptoms \\< 7 days\n* Parent who speaks English\n\nExclusion Criteria:\n\n* history of asthma\n* on any prescribed medication\n* prescribed any medication other than acetaminophen or ibuprofen at index visit\n* use of homeopathic remedy within 48 hours of index visit'}, 'identificationModule': {'nctId': 'NCT01257503', 'briefTitle': 'Homeopathic Cold Remedy for Children Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Randomized Controlled Trial of a Homeopathic Cold Remedy for Children', 'orgStudyIdInfo': {'id': '39489-D'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Homeopathic cold remedy', 'description': '5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms', 'interventionNames': ["Drug: Hyland's Cold 'n Cough 4 kids"]}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': '5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': "Hyland's Cold 'n Cough 4 kids", 'type': 'DRUG', 'description': '5 ml PO q4h prn cold symptoms', 'armGroupLabels': ['Homeopathic cold remedy']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'liquid made to look like the active homeopathic remedy', 'armGroupLabels': ['placebo']}]}, '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'}}}}