Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-02-21 @ 11:18 PM
Study NCT ID:
NCT04031651
Status:
UNKNOWN
Last Update Posted:
2019-07-24
First Post:
2019-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Key Specialized Monitoring of Clinical Safety of Pudilan Xiaoyan Oral Liquid in the Real World
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000627984', 'term': 'Pudilan xiaoyan'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-07-17', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-23', 'studyFirstSubmitDate': '2019-07-12', 'studyFirstSubmitQcDate': '2019-07-23', 'lastUpdatePostDateStruct': {'date': '2019-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Adverse Drug Reaction', 'timeFrame': '7 days', 'description': "Incidence of Reduning Injection'Adverse Drug Reaction（ADRs）and Identify Factors That Contributed to the Occurrence of the Adverse Drug Reaction"}], 'secondaryOutcomes': [{'measure': 'The Ratio of Body Temperature to Normal', 'timeFrame': '7 days', 'description': 'The Ratio of Body Temperature to Normal(Lower Than 37.3ºC)'}, {'measure': 'Change of liver function', 'timeFrame': '7 days', 'description': 'Observation of liver function in at least 3000 patients before and after medication.The liver function includes glutamic-pyruvic transaminase,glutamic-oxalacetic transaminase.To observe whether the above liver function indexes appear abnormal once after medication.'}, {'measure': 'Change of renal function', 'timeFrame': '7 days', 'description': 'Observation of renal function in at least 3000 patients before and after medication.The renal function includes creatinine,usea nitrogen.To observe whether the above renal function indexes appear abnormal once after medication.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pudilan Xiaoyan Oral Liquid', 'Safety monitoring'], 'conditions': ['Respiratory Infectious Diseases']}, 'referencesModule': {'references': [{'pmid': '40117581', 'type': 'DERIVED', 'citation': 'Wang M, Wang L, Liu F, Chen R, Wang Z, Cui X, Li Y, Xie Y. Clinical Safety of Pudilan Xiaoyan Oral Liquid for the Treatment of Upper Respiratory Tract Infection in the Real World: Protocol for a Prospective, Observational, Registry Study. JMIR Res Protoc. 2025 Mar 21;14:e65789. doi: 10.2196/65789.'}]}, 'descriptionModule': {'briefSummary': 'To obtain the characteristics of adverse reactions/incidents, analyze the influencing factors and calculate the incidence of adverse reactions/incidents monitored by Pudilan Xiaoyan Oral Liquid in key specialties in the real world, so as to provide a basis for clinical safe and rational drug use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'To obtain the characteristics of adverse reactions/incidents, analyze the influencing factors and calculate the incidence of adverse reactions/incidents monitored by Pudilan Xiaoyan Oral Liquid in key specialties in the real world, so as to provide a basis for clinical safe and rational drug use.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (1)Upper respiratory tract infection patients using Pudilan antiphlogistic oral liquid ;\n* (2)Aged between 18 and 80.\n\nExclusion Criteria:\n\n* Lactating women, pregnant women, pregnant planners, psychiatric patients, etc.'}, 'identificationModule': {'nctId': 'NCT04031651', 'briefTitle': 'Key Specialized Monitoring of Clinical Safety of Pudilan Xiaoyan Oral Liquid in the Real World', 'organization': {'class': 'OTHER', 'fullName': 'China Academy of Chinese Medical Sciences'}, 'officialTitle': 'Key Specialized Monitoring of Clinical Safety of Pudilan Xiaoyan Oral Liquid in the Real World', 'orgStudyIdInfo': {'id': 'PUDILAN'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Pudilan Xiaoyan Oral Liquid', 'type': 'DRUG', 'description': 'In the respiratory and emergency departments of the hospitals under surveillance, the medication of Pudilan Xiaoyan Oral Liquid is observed for those aged 18-80 years who strictly follow the prescription of the instructions.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yanming Xie, BA', 'role': 'CONTACT', 'email': 'datamining5288@163.com', 'phone': '86-13911112416'}, {'name': 'Qing Miao, doctor', 'role': 'CONTACT', 'email': 'wlxing@126.com', 'phone': '86-13910812309'}], 'overallOfficials': [{'name': 'Yanming Xie, BA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China Academy of Chinese Medical Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Xiyuan Hospital of China Academy of Chinese Medical Sciences', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy Director', 'investigatorFullName': 'Yanming Xie', 'investigatorAffiliation': 'China Academy of Chinese Medical Sciences'}}}}