Chinese Medicinal Herbs Treatment on Novel Influenza A (H1N1) : Multi-centre, Prospective, Randomized Controlled Study
NCT ID: NCT00935194
Last Updated: 2009-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
102 participants
INTERVENTIONAL
2009-07-31
2009-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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blank
do not take antiviral therapy
blank
no antiviral therapy
Oseltamivir
antiviral therapy
oseltamivir
75mg,bid,for 5 days
chinese medicinary herbs
antiviral therapy
chinese medicinal herbs
200ml,p.o,qid,for 5 days
oseltalmivir and chinese medicinal herbs
combination antiviral therapy
oseltamivir and chinese medicinal herbs
oseltamivir:75mg,p.o,bid,for 5 days; chinese medicinal herbs:200ml,p.o,qid,for 5 days
Interventions
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oseltamivir
75mg,bid,for 5 days
blank
no antiviral therapy
chinese medicinal herbs
200ml,p.o,qid,for 5 days
oseltamivir and chinese medicinal herbs
oseltamivir:75mg,p.o,bid,for 5 days; chinese medicinal herbs:200ml,p.o,qid,for 5 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 70 years ≥ age ≥ 14years
* Within 72hr after the onset of symptoms(body temperature≥37.5℃ with at least one respiratory symptom (cough, sore throat, or nasal symptom)
Exclusion Criteria
* Bronchitis, pneumonia, pleural fluid and interstitial infiltration showed by Chest radiology(x-ray or CT)
* 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）
* Immunocompromised patients(cancer, organ transplant, AIDS and a history of treatment with immunosuppressive drug and glucocorticoids in the past 3 months)
* Taken Chinese medicinal herbs, antiviral or antibiotic drug in the past 2 weeks
* Inoculation influenza vaccination
* One of the following items appeared at the enrollment
* respiratory failure：PaO2\<60mmHg and/or PCO2\>50mmHg or PaO2/FiO2≤300
* circulation failure: despite adequate fluid resuscitation and cardiac output, systolic \<90mmHg or requirement inotropic support
* renal function failure: despite adequate fluid resuscitation and cardiac output, urine ≤ 0.5ml/kg.h, Cr or BUN≥1 time normal elevation
* hepatic function failure: total bilirubin\>34μmol/L or ALT/AST ≥3 times normal - Other unappropriated enrollment situations considered by investigator
14 Years
70 Years
ALL
No
Sponsors
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Capital Medical University
OTHER
Responsible Party
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Capital Medical University Affiliated Beijing Chaoyang Hospital
Principal Investigators
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Chen Wang, Doctor
Role: STUDY_CHAIR
Capital Medical University affiliated Beijing Chaoyang Hospital, Beijing Respiratory Medicine Insititute
Qingquan Liu, Docter
Role: PRINCIPAL_INVESTIGATOR
Beijing Chinese Traditional Medicine University affiliated Dongzhimen Hospital
Yu Mao, Doctor
Role: PRINCIPAL_INVESTIGATOR
Beijing Ditan Hospital
Locations
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Capital Medical University affiliated Beijing Chaoyang Hospital, Beijing Respiratory Medicine Insititute
Beijing, , China
Countries
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References
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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.
Other Identifiers
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Z09000700090903
Identifier Type: -
Identifier Source: org_study_id