Chinese Medicinal Herbs Treatment on Novel Influenza A (H1N1)Pneumonia: Multi-centre, Prospective, Randomized Controlled Study
NCT ID: NCT00936013
Last Updated: 2009-11-02
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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UNKNOWN
PHASE4
400 participants
INTERVENTIONAL
2009-08-31
2011-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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oseltamivir
single antiviral treatment
oseltamivir
75mg p.o Bid for 5 days
oseltimivir and chinese medicinal herbs
combination treatment
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 p.o Bid 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 ys ≥ age ≥14ys
* Within 72hr after the onset of symptoms(body temperature≥37.5℃ with at least one respiratory symptom (cough, sore throat, or nasal symptom)
* New lung infiltration showed by chest radiology(x-ray or CT)
Exclusion Criteria
* Pregnancy
* Severe chronic underlying diseases: severe COPD(FEV1/EVC \<70% and FEV1 \<30% predicted or respiratory failure or congestive heart failure), severe liver 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
* liver function failure: total bilirubin\>34μmol/L or ALT/AST ≥3 times normal elevation
* 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
Beijing Chao Yang Hospital
Qingquan Liu, Docter
Role: STUDY_DIRECTOR
Beijing Chinese Traditional Medicine University affiliated Dongzhimen Hospital
Yu Mao, Doctor
Role: STUDY_DIRECTOR
Beijing Ditan Hospital
Locations
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Capital Medical University affiliated Bejing Chaoyang Hospital, Beijing Respiratory Medicine Institute
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Z09000700090903-2
Identifier Type: -
Identifier Source: org_study_id
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