Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2026-04-23 @ 6:54 AM
Study NCT ID:
NCT02654158
Status:
COMPLETED
Last Update Posted:
2017-05-22
First Post:
2016-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase IV Trial,The Efficacy and Safety Study of Fuganlin Oral Liquid in Children With Acute Upper Respiratory Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-18', 'studyFirstSubmitDate': '2016-01-11', 'studyFirstSubmitQcDate': '2016-01-11', 'lastUpdatePostDateStruct': {'date': '2017-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of cold symptoms', 'timeFrame': 'Defined as the time from the onset of the cold to the time achieve a cold cure standard,time average 1 to 7 days', 'description': 'Cold diagnostic criteria：\n\n1. Nasal congestion, runny nose, sneezing, itchy throat, or pain, cough\n2. The chills, fever, no sweat or less sweat, headache, limb sour\n3. The total numbers of normal or low white blood cells, neutropenia, relative increase in lymphocytes.\n\nCold cure criteria:\n\n1. Fever, aversion to wind individual symptoms disappeared\n2. Nasal congestion, runny nose, sore throat, cough individual symptoms disappeared'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['acute upper respiratory infection'], 'conditions': ['Acute Upper Respiratory Infection']}, 'descriptionModule': {'briefSummary': 'Phase IV trial,Single-arm, multi-centre clinical trial to assess the efficacy and safety of Fuganlin Oral Liquid in children with acute upper respiratory infection', 'detailedDescription': 'Low-dose group of Fuganlin Oral Liquid:dosage from 5 to 10 ml;\n\nHigh-dose group of Fuganlin Oral Liquid:dosage from 10 to 20 ml;\n\nTreatment for 1 week.Patients who were recovered within 1 week can withdrawal at any time.\n\nResearch purpose:\n\n1. Evaluate the safety and efficacy of Fuganlin oral Liquid when expanding the designated indications(Qi deficiency wind-heat syndrome to wind-heat syndrome) .\n2. Explore the relationship between elevated white blood cells and efficacy, age and efficacy, dose and efficacy,While treating with Fuganlin oral Liquid in children with acute respiratory infection.\n3. Observe the antiviral and immunomodulatory effects of Fuganlin oral Liquid.\n4. Provide data to support the clinical medicine guidelines and labels amendment of Fuganlin oral Liquid.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '1 Year', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Children aged 1 to 12 years old with acute upper respiratory infection', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients diagnosed as acute upper respiratory infection.\n2. Patients with acute upper respiratory infection diagnosed as Tradition Chinese Medicine syndrome qi deficiency wind-heat.\n3. Patients aged 1 to 12 years old.\n4. Parents or guardians agreed to participate this study and signed the informed consent.\n\nExclusion Criteria:\n\n1. Patients whose total numbers of white blood cells around above1.3ULN.\n2. Patients diagnosed as suppurative tonsillitis, otitis media, bronchitis and other airway.\n3. Patients allergic to the test drug.\n4. Serious cardiovascular, liver,kidney and other primary systemic diseases.\n5. Patients should not be included in group according to investigator's evaluation."}, 'identificationModule': {'nctId': 'NCT02654158', 'briefTitle': 'Phase IV Trial,The Efficacy and Safety Study of Fuganlin Oral Liquid in Children With Acute Upper Respiratory Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Guangzhou Yipinhong Pharmaceutical CO.,LTD'}, 'officialTitle': 'Phase IV Trial,The Efficacy and Safety Study of Fuganlin Oral Liquid in Children With Acute Upper Respiratory Infection', 'orgStudyIdInfo': {'id': '2013Pro234.EKZY'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Low-dose of Fuganlin Oral Liquid', 'description': 'oral\n\nless than 1 years old: 5mL each time and three times a day\n\n1\\~3 years old: 10mL each time and three times a day\n\n4\\~6 years old: 10mL each time and four times a day\n\n7\\~12 years old: 10mL each time and five times a day', 'interventionNames': ['Drug: Low-dose of Fuganlin Oral Liquid']}, {'label': 'High-dose of Fuganlin Oral Liquid', 'description': 'oral\n\nless than 1 years old: 10mL each time and three times a day\n\n1\\~3 years old: 20mL each time and three times a day\n\n4\\~6 years old: 20mL each time and four times a day\n\n7\\~12 years old: 20mL each time and five times a day', 'interventionNames': ['Drug: High-dose of Fuganlin Oral Liquid']}], 'interventions': [{'name': 'Low-dose of Fuganlin Oral Liquid', 'type': 'DRUG', 'otherNames': ['No other names'], 'description': 'less than 1 years old: 5mL each time and three times a day\n\n1\\~3 years old: 10mL each time and three times a day\n\n4\\~6 years old: 10mL each time and four times a day\n\n7\\~12 years old: 10mL each time and five times a day', 'armGroupLabels': ['Low-dose of Fuganlin Oral Liquid']}, {'name': 'High-dose of Fuganlin Oral Liquid', 'type': 'DRUG', 'otherNames': ['No other names'], 'description': 'less than 1 years old: 10mL each time and three times a day\n\n1\\~3 years old: 20mL each time and three times a day\n\n4\\~6 years old: 20mL each time and four times a day\n\n7\\~12 years old: 20mL each time and five times a day', 'armGroupLabels': ['High-dose of Fuganlin Oral Liquid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '440100', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Guangdong Provincial Hospital of Traditional Chinese Medicine', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Li xinmin, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'The First Affiliated Hospital of Tianjing University of Traditional Chinese Medicine'}, {'name': 'Chang ke, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chengdu University of Traditional Chinese Medicine'}, {'name': 'Meng qingping, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Zhengzhou Children's Hospital"}, {'name': 'Tao lei, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Huanggang Maternal and Child Health Hospital'}, {'name': 'Ding ying, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of The First Affiliated Hospital of Henan College of Traditional Chinese Medicine"}, {'name': 'Xiang xixiong, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hubei Hospital of Traditional Chinese Medicine'}, {'name': 'Cheng ji, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Affiliated Hospital of Wenzhou Medical University'}, {'name': 'Ying yong, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Affiliated Shanghai Children's Medical Center of Shanghai Jiaotong University School of medicine"}, {'name': 'Liu changshan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tianjin Medical University Second Hospital'}, {'name': 'Mou qinghui, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Jinan children's hospital"}, {'name': 'Liu yulin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'BoAi Hospital of Zhongshan'}, {'name': 'Wang lisheng, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Shenzhen Children's Hospital"}, {'name': 'Zhao deyu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Affiliated Nanjing Children's Hospital of Nanjing Medical University"}, {'name': 'Du yonggang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Changzhi People's Hospital"}, {'name': 'Su baoling, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Affiliated Heji Hospital of Changzhi Medical College'}, {'name': 'Qing yanhong, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Affiliated Hospital of Shanxi College of Traditional Chinese medicine'}, {'name': 'Cheng zhimin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Affiliated Children's Hospital of Zhejiang University School of Medicine"}, {'name': 'Lin yan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Chengdu Women and Children's Hospital"}, {'name': 'Xu youjia, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Guangdong Provincial Hospital of Traditional Chinese Medicine'}, {'name': 'Zhang mingying, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Shunyi Hospital of China Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangzhou Yipinhong Pharmaceutical CO.,LTD', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}