Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-31 @ 8:17 PM
Study NCT ID:
NCT01053533
Status:
UNKNOWN
Last Update Posted:
2010-06-08
First Post:
2010-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pragmatic Randomized Controlled Trial of Chinese Herbal Medicine for Severe Pandemic H1N1 Influenza
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2010-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-06-07', 'studyFirstSubmitDate': '2010-01-19', 'studyFirstSubmitQcDate': '2010-01-20', 'lastUpdatePostDateStruct': {'date': '2010-06-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of complication', 'timeFrame': '10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients.'}, {'measure': 'mortality of pandemic H1N1 influenza and all-cause mortality(only for severe pandemic H1N1 influenza patients)', 'timeFrame': '28 days'}, {'measure': 'proportion of deteriorating into severe H1N1 influenza (only for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza)', 'timeFrame': '10 days'}], 'secondaryOutcomes': [{'measure': 'time to allaying a fever', 'timeFrame': '10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients'}, {'measure': 'time to symptom relief', 'timeFrame': '10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients'}, {'measure': 'time and proportion of H1N1 virus turning to negative', 'timeFrame': '10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients'}, {'measure': 'direct medical cost', 'timeFrame': '10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients'}, {'measure': 'safety outcome(adverse effects)', 'timeFrame': '10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients'}, {'measure': 'days in hospital', 'timeFrame': '10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients'}, {'measure': 'dose and usage of hormones(only for severe pandemic H1N1 influenza patients)', 'timeFrame': '28 days'}, {'measure': 'Inflammation of lung tissue(only for severe pandemic H1N1 influenza patients)', 'timeFrame': '28 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Chinese herbal medicines', 'pandemic H1N1 influenza', 'effectiveness', 'safety'], 'conditions': ['Influenza A Virus, H1N1 Subtype']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the effectiveness and safety of Chinese herbal medicines for severe pandemic H1N1 influenza.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of severe pandemic H1N1 influenza patients and pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza\n* Rapid Diagnostic Tests:positive\n* Age≥6 years\n* Influenza symptoms occurred less than 48 hours and body temperature≥37.5℃ for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza\n\nExclusion Criteria:\n\n* Suffering from mental illness\n* Attending other clinical studies on influenza\n* Critical pandemic H1N1 influenza patients'}, 'identificationModule': {'nctId': 'NCT01053533', 'acronym': '200907001-2A', 'briefTitle': 'A Pragmatic Randomized Controlled Trial of Chinese Herbal Medicine for Severe Pandemic H1N1 Influenza', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Ditan Hospital'}, 'orgStudyIdInfo': {'id': '20100118'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chinese herbal medicines plus western therapy', 'interventionNames': ['Drug: Chinese herbal medicines plus western therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'western therapy', 'description': 'including supportive therapy and antivirus therapy when necessary', 'interventionNames': ['Drug: western therapy']}], 'interventions': [{'name': 'Chinese herbal medicines plus western therapy', 'type': 'DRUG', 'description': 'injections of Chinese herbal medicines and Chinese herbal medicines decoction\\& supportive therapy and antivirus therapy when necessary', 'armGroupLabels': ['Chinese herbal medicines plus western therapy']}, {'name': 'western therapy', 'type': 'DRUG', 'description': 'supportive therapy and antivirus therapy when necessary', 'armGroupLabels': ['western therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100015', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yu Mao', 'role': 'CONTACT', 'email': 'myqmz58@yahoo.com'}, {'name': 'Guang Yu Wang', 'role': 'CONTACT', 'email': 'influenzatcm@163.com'}, {'name': 'Guang YU Wang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mao Yu', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Ditan Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beijing University of Chinese Medicine', 'class': 'OTHER'}, {'name': "State Administration of Traditional Chinese Medicine of the People's Republic of China", 'class': 'OTHER_GOV'}, {'name': 'China Academy of Chinese Medical Sciences', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Beijing Di Tan Hospital', 'oldOrganization': 'Beijing Di Tan Hospital'}}}}