Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-02-22 @ 7:23 PM
Study NCT ID:
NCT00935194
Status:
COMPLETED
Last Update Posted:
2009-12-01
First Post:
2009-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chinese Medicinal Herbs Treatment on Novel Influenza A (H1N1) : Multi-centre, Prospective, Randomized Controlled Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D053139', 'term': 'Oseltamivir'}], 'ancestors': [{'id': 'D000081', 'term': 'Acetamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D053138', 'term': 'Cyclohexenes'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-11-30', 'studyFirstSubmitDate': '2009-07-07', 'studyFirstSubmitQcDate': '2009-07-07', 'lastUpdatePostDateStruct': {'date': '2009-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time to resolution of fever (the period from start of study-drug to relief of fever)', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'time to resolution of respiratory symptoms(defined as the period from start of study-drug to relief of symptoms)', 'timeFrame': 'one year'}, {'measure': 'virus shedding time', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Novel Influenza A(H1N1)', 'Oseltamivir', 'Chinese Medicinal Herbs'], 'conditions': ['Influenza']}, 'referencesModule': {'references': [{'pmid': '21844547', 'type': 'DERIVED', 'citation': 'Wang C, Cao B, Liu QQ, Zou ZQ, Liang ZA, Gu L, Dong JP, Liang LR, Li XW, Hu K, He XS, Sun YH, An Y, Yang T, Cao ZX, Guo YM, Wen XM, Wang YG, Liu YL, Jiang LD. Oseltamivir compared with the Chinese traditional therapy maxingshigan-yinqiaosan in the treatment of H1N1 influenza: a randomized trial. Ann Intern Med. 2011 Aug 16;155(4):217-25. doi: 10.7326/0003-4819-155-4-201108160-00005.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether Chinese medicinal herbs are effective and safe for treating novel influenza A (H1N1) infection.', 'detailedDescription': 'The antiviral agent, oseltamivir, is recommended by the World Health Organization (WHO) to treat recent outbreak novel influenza A (H1N1) virus infection around world. But limited stock and resistant strain emergence raised increasing concerns. Chinese medicinal herbs, are derived from plants and usually incorporate one or more herbs as the basic drug(s) to treat the disease. The investigators performed RCT to indicate that Chinese medicinal herbs was effective and safe for treating novel influenza A (H1N1) infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed novel influenza A(H1N1) case with laboratory evidence\n* 70 years ≥ age ≥ 14years\n* Within 72hr after the onset of symptoms(body temperature≥37.5℃ with at least one respiratory symptom (cough, sore throat, or nasal symptom)\n\nExclusion Criteria:\n\n* Age \\< 14 years or \\> 70 years\n* Bronchitis, pneumonia, pleural fluid and interstitial infiltration showed by Chest radiology(x-ray or CT)\n* Severe chronic underlying diseases: severe COPD(FEV1/EVC \\<70% and FEV1 \\<30% predicted or respiratory failure or congestive heart failure), severe hepatic disfunction（ALT or AST ≥3 times normal elevation), renal disfunction（Cr\\>2mg/dL), chronic heart failure(NYHA Ⅲ-Ⅳ grade）\n* Immunocompromised patients(cancer, organ transplant, AIDS and a history of treatment with immunosuppressive drug and glucocorticoids in the past 3 months)\n* Taken Chinese medicinal herbs, antiviral or antibiotic drug in the past 2 weeks\n* Inoculation influenza vaccination\n* One of the following items appeared at the enrollment\n\n * respiratory failure：PaO2\\<60mmHg and/or PCO2\\>50mmHg or PaO2/FiO2≤300\n * circulation failure: despite adequate fluid resuscitation and cardiac output, systolic \\<90mmHg or requirement inotropic support\n * renal function failure: despite adequate fluid resuscitation and cardiac output, urine ≤ 0.5ml/kg.h, Cr or BUN≥1 time normal elevation\n * hepatic function failure: total bilirubin\\>34μmol/L or ALT/AST ≥3 times normal - Other unappropriated enrollment situations considered by investigator'}, 'identificationModule': {'nctId': 'NCT00935194', 'briefTitle': 'Chinese Medicinal Herbs Treatment on Novel Influenza A (H1N1) : Multi-centre, Prospective, Randomized Controlled Study', 'organization': {'class': 'OTHER', 'fullName': 'Capital Medical University'}, 'officialTitle': 'Antiviral and Chinese Medicinal Herbs Treatment on Novel Influenza A (H1N1) Virus Infection: Multi-centre, Prospective, Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'Z09000700090903'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'blank', 'description': 'do not take antiviral therapy', 'interventionNames': ['Other: blank']}, {'type': 'EXPERIMENTAL', 'label': 'Oseltamivir', 'description': 'antiviral therapy', 'interventionNames': ['Drug: oseltamivir']}, {'type': 'EXPERIMENTAL', 'label': 'chinese medicinary herbs', 'description': 'antiviral therapy', 'interventionNames': ['Drug: chinese medicinal herbs']}, {'type': 'EXPERIMENTAL', 'label': 'oseltalmivir and chinese medicinal herbs', 'description': 'combination antiviral therapy', 'interventionNames': ['Drug: oseltamivir and chinese medicinal herbs']}], 'interventions': [{'name': 'oseltamivir', 'type': 'DRUG', 'otherNames': ['TamifluTM'], 'description': '75mg,bid,for 5 days', 'armGroupLabels': ['Oseltamivir']}, {'name': 'blank', 'type': 'OTHER', 'description': 'no antiviral therapy', 'armGroupLabels': ['blank']}, {'name': 'chinese medicinal herbs', 'type': 'DRUG', 'description': '200ml,p.o,qid,for 5 days', 'armGroupLabels': ['chinese medicinary herbs']}, {'name': 'oseltamivir and chinese medicinal herbs', 'type': 'DRUG', 'description': 'oseltamivir:75mg,p.o,bid,for 5 days; chinese medicinal herbs:200ml,p.o,qid,for 5 days', 'armGroupLabels': ['oseltalmivir and chinese medicinal herbs']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100020', 'city': 'Beijing', 'country': 'China', 'facility': 'Capital Medical University affiliated Beijing Chaoyang Hospital, Beijing Respiratory Medicine Insititute', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Chen Wang, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'Capital Medical University affiliated Beijing Chaoyang Hospital, Beijing Respiratory Medicine Insititute'}, {'name': 'Qingquan Liu, Docter', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Chinese Traditional Medicine University affiliated Dongzhimen Hospital'}, {'name': 'Yu Mao, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Ditan Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Capital Medical University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Wang Chen', 'oldOrganization': 'Capital Medical University Affiliated Beijing Chaoyang Hospital'}}}}