Status:
COMPLETED
Chinese Medicinal Herbs Treatment on Novel Influenza A (H1N1) : Multi-centre, Prospective, Randomized Controlled Study
Lead Sponsor:
Capital Medical University
Conditions:
Influenza
Eligibility:
All Genders
14-70 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine whether Chinese medicinal herbs are effective and safe for treating novel influenza A (H1N1) infection.
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Confirmed novel influenza A(H1N1) case with laboratory evidence
- 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
- Age \< 14 years or \> 70 years
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT00935194
Start Date
July 1 2009
End Date
November 1 2009
Last Update
December 1 2009
Active Locations (1)
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1
Capital Medical University affiliated Beijing Chaoyang Hospital, Beijing Respiratory Medicine Insititute
Beijing, China, 100020