Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT02328651
Status:
COMPLETED
Last Update Posted:
2018-08-07
First Post:
2014-12-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Xiaoer Jiebiao Oral Liquid on Hand-foot-mouth Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008224', 'term': 'Lymphoma, Follicular'}], 'ancestors': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012254', 'term': 'Ribavirin'}], 'ancestors': [{'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-05', 'studyFirstSubmitDate': '2014-12-18', 'studyFirstSubmitQcDate': '2014-12-29', 'lastUpdatePostDateStruct': {'date': '2018-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time (hours) taken from treatment start till body temperature dropping to normal', 'timeFrame': 'time length( hours) from treatment starting to the time that body temperature drop to normal 37.0 degree for 12 hours'}, {'measure': 'Time (hours) taken from disease onset till body temperature dropping to normal', 'timeFrame': 'time length (hours) from the disease onset (the starting of fever) till the time that body temperature dropped to normal (37.0 degree) and lasting for at least 12 hours'}, {'measure': 'Top body temperature at the 24th hour, 48th hour and the 72th hour from treatment starting.', 'timeFrame': 'from starting of treatment to the 24th hour, 48th hour, and the 72th hour', 'description': 'top body temperature at 3 time points after treatment diarrhea'}], 'secondaryOutcomes': [{'measure': 'adverse digestive tract symptoms', 'timeFrame': 'from start of treatment to discharge', 'description': 'proportion of patients with digestive tract symptoms during treatment, such as vomit, abdomial pain or diarrhea'}, {'measure': 'abnormal blood routine', 'timeFrame': 'from the start of treatment to discharge test', 'description': 'defined as 1 if any abnormal blood routine occur, otherwise defined as 0'}, {'measure': 'abnormal Urine routine', 'timeFrame': 'from the start of treatment to discharge', 'description': 'defined as 1 if any liver function examination or kidney function examination occur, otherwise defined as 0'}]}, 'conditionsModule': {'keywords': ['Mild and Moderate Severe Patients With hand_foot-mouth Disease'], 'conditions': ['Handfoot-mouth Disease']}, 'descriptionModule': {'briefSummary': 'This is a single-blinded randomized trial aiming to evaluate the effectiveness of Xiaoer Jiebiao Oral liquid in combination with Ribavirin treatment on patients with hand-foot-mouth disease compared with the controlgroup that recieve only libavirin treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:subjects should meet all of the following\n\n* diagnosed as hand-foot-mouth disease grade I or grade II;\n* body temperature at admission T\\>38℃，fever length\\<48 hours;\n* no need for hormonotherapy or immunoglobulin therapy.\n* signed written informed consent form\n\nExclusion Criteria:subjects should be excluded if meet any of the following\n\n* with history of any heart, lung, kidney or liver diseases; under any hormonotherapy, immunoglobulin therapy or any other therapy.'}, 'identificationModule': {'nctId': 'NCT02328651', 'briefTitle': 'Effect of Xiaoer Jiebiao Oral Liquid on Hand-foot-mouth Disease', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Fudan University"}, 'officialTitle': "Effect and Safety of Xiao'er Jiebiao Oral Liquid in Combination With Standard Treatment on Hand-foot-mouth Disease in Pediatric Patients", 'orgStudyIdInfo': {'id': 'XEJB_Ver1.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ribavirin treatment plus testing drug', 'interventionNames': ["Drug: Ribavirin plus Xiao'er jiebiao oral liquid"]}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ribavirin treatment', 'interventionNames': ['Drug: Ribavirin']}], 'interventions': [{'name': "Ribavirin plus Xiao'er jiebiao oral liquid", 'type': 'DRUG', 'description': 'For mild (Phase I) patients: recommended treatment according to naitonal guildeline for treatment of mouth-foot-hand diseases 2010, including ①treatment for control symptoms ② ribavirin 15mg/kg/d（ diluted in 100ml 5%GS），qd, ivgg, in combination using of Xiaoer jiebiao oral liquid 5 ml, bid for children aged 1-2 years, tid for children aged 3-5 years.\n\nFor moderate (Phase II) patients:\n\nrecommended treatment according to naitonal guildeline for treatment of mouth-foot-hand diseases 2010, including ①treatment for control symptoms ② ribavirin 15mg/kg/d（ diluted in 100ml 5%GS），qd, intravenous drip, in combination using of Xiaoer jiebiao oral liquid 5 ml, bid for children aged 1-2 years, tid for children aged 3-5 years.③anti-intracranial pressure treatment: mannitol 2\\~5ml/kg,iv, Bid\\~tid）', 'armGroupLabels': ['Ribavirin treatment plus testing drug']}, {'name': 'Ribavirin', 'type': 'DRUG', 'description': 'For mild (PhaseI) patients : recommended treatment according to naitonal guildeline for treatment of mouth-foot-hand diseases 2010, including ①treatment for control symptoms ② ribavirin 15mg/kg/d（ diluted in 100ml 5%GS），qd, intravenous drip.\n\nFor moderate (PhaseII) patients: recommended treatment according to naitonal guildeline for treatment of mouth-foot-hand diseases 2010, including ①treatment for control symptoms ② ribavirin 15mg/kg/d（ diluted in 100ml 5%GS），qd, intravenous drip, in combination using of Xiaoer jiebiao oral liquid 5 ml, bid for children aged 1-2 years, tid for children aged 3-5 years.③anti-intracranial pressure treatment: mannitol 2\\~5ml/kg, iv, Bid\\~tid）', 'armGroupLabels': ['Ribavirin treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '201102', 'city': 'Shanghai', 'country': 'China', 'facility': "Children's Hospital of Fudan University", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Fudan University", 'class': 'OTHER'}, 'collaborators': [{'name': 'Weihai Rensheng Pharmacy', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Director', 'investigatorFullName': 'Hui Yu', 'investigatorAffiliation': "Children's Hospital of Fudan University"}}}}