Ignite Creation Date:
2025-12-24 @ 2:25 PM
Ignite Modification Date:
2026-01-28 @ 2:41 PM
Study NCT ID:
NCT02622659
Status:
COMPLETED
Last Update Posted:
2017-05-22
First Post:
2015-11-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy and Safety Study of Fuganlin Oral Liquid in Children With Influenza (Acute Upper Respiratory Infection)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 468}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-18', 'studyFirstSubmitDate': '2015-11-16', 'studyFirstSubmitQcDate': '2015-12-03', 'lastUpdatePostDateStruct': {'date': '2017-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The 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 3 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 number normal or low of 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': 'Randomized, double blind, double dummy, positive drug parallel comparison, multi-centre clinical trial to assess the efficacy and safety of Fuganlin Oral Liquid in children with influenza (acute upper respiratory infection).', 'detailedDescription': 'Treatment group: Fuganlin Oral Liquid 10mL. Control group: Xiaoer Jiebiao oral liquid 100mL. Treatment for one week. Patients who were recovered within one week can withdrawal at any time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients diagnosed as acute upper respiratory infection.\n2. Patients with Traditional Chinese Medicine syndrome of qi deficiency and wind-heat.\n3. Patients aged 1 to 12 years.\n4. With course of disease in 48 hours or less.\n5. Signed informed consent by a Parent or legal guardians.\n\nExclusion Criteria:\n\n1. Patients diagnosed as tonsillitis, bronchitis, bronchiolitis, pneumonia;\n2. Patients have a history of hyperpyretic convulsion;\n3. Severe malnutrition, rickets patients and merge the heart, brain, liver, kidney and hematopoietic system and other serious primary diseases;\n4. The increased of serum creatinine (Cr), blood urea nitrogen (BUN), alanine aminotransferase (ALT), and urinary protein, urine RBC above "+", which can not use the test illness or possibly combined disease conditions to explain;\n5. Patients with allergic physique (Allergic to above two kinds of substance), allergic to the composition of the preparation or control drug;\n6. According to the doctors\' determination,likely to loss to follow up.'}, 'identificationModule': {'nctId': 'NCT02622659', 'briefTitle': 'The Efficacy and Safety Study of Fuganlin Oral Liquid in Children With Influenza (Acute Upper Respiratory Infection)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Guangzhou Yipinhong Pharmaceutical CO.,LTD'}, 'officialTitle': 'The Efficacy and Safety Study of Fuganlin Oral Liquid in Children With Influenza (Acute Upper Respiratory Infection)', 'orgStudyIdInfo': {'id': '2012Pro170EKZY'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fuganlin Oral Liquid', 'description': 'Fuganlin Oral Liquid: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\n\nXiaoer Jiebiao Oral Liquid placebo:oral\n\n1\\~2 years old: 5mL each time and twice a day\n\n3\\~5 years old: 5mL each time and three times a day\n\n6\\~14 years old: 10mL each time and twice a day', 'interventionNames': ['Drug: Fuganlin Oral Liquid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Xiaoer Jiebiao Oral Liquid', 'description': 'Xiaoer Jiebiao Oral Liquid:oral\n\n1\\~2 years old: 5mL each time and twice a day\n\n3\\~5 years old: 5mL each time and three times a day\n\n6\\~14 years old: 10mL each time and twice a day\n\nFuganlin Oral Liquid placebo: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: Xiaoer Jiebiao Oral Liquid']}], 'interventions': [{'name': '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': ['Fuganlin Oral Liquid']}, {'name': 'Xiaoer Jiebiao Oral Liquid', 'type': 'DRUG', 'otherNames': ['No other names'], 'description': '1\\~2 years old: 5mL each time and twice a day\n\n3\\~5 years old: 5mL each time and three times a day\n\n6\\~14 years old: 10mL each time and twice a day', 'armGroupLabels': ['Xiaoer Jiebiao Oral Liquid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '462000', 'city': 'Luohe', 'state': 'Henan', 'country': 'China', 'facility': 'Luohe traditional Chinese medicine hospital', 'geoPoint': {'lat': 33.56394, 'lon': 114.04272}}], 'overallOfficials': [{'name': 'Cao xia, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Chongqing First People's Hospital"}, {'name': 'Yan yunying, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nanning maternal and Child Health Hospital'}, {'name': 'Hu suping, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nanchang City Hospital of integrated traditional Chinese and Western Medicine'}, {'name': 'Wang leping, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Changzhou traditional Chinese medicine hospital'}, {'name': 'Liu Dexing, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Liuzhou traditional Chinese medicine hospital'}, {'name': 'Qi Shihe, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xiangyang Central Hospital'}, {'name': 'Ding Lijun, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Handan traditional Chinese medicine hospital'}, {'name': 'Yang Liping, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Changzhi City People's Hospital"}, {'name': 'Feng Ziwei, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Luohe traditional Chinese medicine hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangzhou Yipinhong Pharmaceutical CO.,LTD', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}