Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-01-06 @ 11:18 PM
Study NCT ID:
NCT01769794
Status:
COMPLETED
Last Update Posted:
2013-01-17
First Post:
2013-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chinese Medicinal Treatment on Mild Hand, Foot, and Mouth Disease: Multicenter, Prospective, Randomized Double-blind, Placebo-controlled Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006232', 'term': 'Hand, Foot and Mouth Disease'}, {'id': 'D004769', 'term': 'Enterovirus Infections'}, {'id': 'D005334', 'term': 'Fever'}], 'ancestors': [{'id': 'D003384', 'term': 'Coxsackievirus Infections'}, {'id': 'D010850', 'term': 'Picornaviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 288}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-16', 'studyFirstSubmitDate': '2013-01-15', 'studyFirstSubmitQcDate': '2013-01-16', 'lastUpdatePostDateStruct': {'date': '2013-01-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The time of body temperature going back to normal', 'timeFrame': '10 days', 'description': 'Referring to the time of the armpit temperature of lower than 37.0 degrees Celsius, lasting for at least 24 hours, after the medicine is taken.'}], 'secondaryOutcomes': [{'measure': 'Healing time of skin or oral mucosa lesions symptom', 'timeFrame': '10 days', 'description': 'Referring to the number of days in the total-contact cast until the skin completely closed after the medicine is used.'}, {'measure': 'Score of skin or oral mucosa lesions symptom during the study period time', 'timeFrame': '10 days', 'description': 'Referring to Symptoms were hands, feet, oral mucosa lesions, buttock, crissum, back and four limbs. Each symptom was scored as 0 (none), 1 (mild), 2 (modest), or 3 (severe).'}, {'measure': 'the length of hospital stay', 'timeFrame': '10 days'}, {'measure': 'major complications rate', 'timeFrame': '10 days', 'description': 'Referring to pulmonary edema, cardiac damage, pneumonia, secondary infection, meningitis, encephalomyelitis et al.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hand, Foot and Mouth Disease', 'Medicine, Chinese Traditional', 'Enterovirus', 'Fever'], 'conditions': ['Hand, Foot and Mouth Disease']}, 'descriptionModule': {'briefSummary': 'The study is aimed to evaluate the effectiveness and safety of Jinlianqingre Effervescent Tablets, a traditional Chinese medicine (TCM), in the treatment of Uncomplicated hand, foot, and mouth disease (HFMD).', 'detailedDescription': 'By adopting a multicenter, prospective, randomized double-blind, placebo-controlled, this study is aimed to evaluate the effectiveness, safety of a traditional Chinese medicine, Jinlianqingre Effervescent Tablets, for treatment Uncomplicated HFMD, and to provide scientific evidence for the construction of TCM methods in treating HFMD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinical diagnosis of mild hand-foot-mouth disease patients according to Hand-Foot-Mouth Disease Treatment Guidelines 2010 issued by China's Ministry of Health;\n* Within 48 hours of onset of fever and rash symptom.\n* Age of 1-13 years.\n* Documented body temperature 37.4 °C-39.0°C\n* Patients or their guardians agree to participate in this study and signed the informed consent form.\n\nExclusion Criteria:\n\n* Complicated with other serious diseases such as chronic hepatitis,chronic diarrhea disease,chronic diarrhea, congenital heart disease, acute or chronic nephritis and blood diseases.\n* With history of allergies on traditional Chinese medicine.\n* Attending other clinical studies on HFMD after diagnosed."}, 'identificationModule': {'nctId': 'NCT01769794', 'briefTitle': 'Chinese Medicinal Treatment on Mild Hand, Foot, and Mouth Disease: Multicenter, Prospective, Randomized Double-blind, Placebo-controlled Study', 'organization': {'class': 'OTHER', 'fullName': 'China Academy of Chinese Medical Sciences'}, 'orgStudyIdInfo': {'id': 'ChinaACMS-HFMD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Western therapy & Placebo', 'description': 'Western therapy(oral care, skin care and reducing temperature) Placebo for JET(Jinlianqingre Effervescent Tablets )', 'interventionNames': ['Drug: Western therapy', 'Drug: Placebo(for JET)']}, {'type': 'EXPERIMENTAL', 'label': 'Western therapy & JET', 'description': 'Jinlianqingre Effervescent Tablets plus western therapy', 'interventionNames': ['Drug: Western therapy', 'Drug: JET']}], 'interventions': [{'name': 'Western therapy', 'type': 'DRUG', 'description': "Physical cooling paste or warm bathing, vitamin B, vitamin C. On the basis of the attending physician's judgment, participants were allowed to use Ibuprofen suspension if their body temperature was greater than 38.5℃. Likewise, the need for antibiotics was determined by the attending physicians. The use of acetaminophen or antibiotics was recorded on the case record form", 'armGroupLabels': ['Western therapy & JET', 'Western therapy & Placebo']}, {'name': 'JET', 'type': 'DRUG', 'otherNames': ['Jinlianqingre Effervescent Tablets'], 'description': '4g/tablet, One tablet each time (Taken after dissolved in 50ml boiled water, 3 times daily if body temperature≥38.5℃)', 'armGroupLabels': ['Western therapy & JET']}, {'name': 'Placebo(for JET)', 'type': 'DRUG', 'description': 'placebos prepared identical in color, taste and consistency to the JET (supplied by Zhongshenghaitian Pharmaceutical, Tianjin, China)', 'armGroupLabels': ['Western therapy & Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '063020', 'city': 'Tangshan', 'state': 'Hebei', 'country': 'China', 'facility': 'Tangshan infectious disease hospital', 'geoPoint': {'lat': 39.64381, 'lon': 118.18319}}, {'zip': '610072', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'Affiliated Hospital of Chengdu university of Traditional Chinese Medicine', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '100045', 'city': 'Beijing', 'country': 'China', 'facility': "Beijing children's hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '300192', 'city': 'Tianjin', 'country': 'China', 'facility': 'Tianjin infectious disease hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'overallOfficials': [{'name': 'Boyan Liu, chief physician', 'role': 'STUDY_CHAIR', 'affiliation': 'China Academy of Chinese Medical Sciences'}, {'name': 'Guoliang Zhang, chief', 'role': 'STUDY_CHAIR', 'affiliation': 'The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China Academy of Chinese Medical Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chengdu University of Traditional Chinese Medicine', 'class': 'OTHER'}, {'name': "Beijing Children's Hospital", 'class': 'OTHER'}, {'name': 'Tianjin infectious disease hospital', 'class': 'UNKNOWN'}, {'name': 'Tangshan infectious disease hospital', 'class': 'UNKNOWN'}, {'name': 'The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine', 'class': 'OTHER'}, {'name': 'Tianjin Zhongshenghaitian Pharmaceutical Co. Ltd.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'chief', 'investigatorFullName': 'Liyun He', 'investigatorAffiliation': 'China Academy of Chinese Medical Sciences'}}}}