Chinese Medicinal Herbs Treatment on Novel Influenza A (H1N1)Pneumonia: Multi-centre, Prospective, Randomized Controlled Study

• Status: Unknown status
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to determine whether the combination treatment of Chinese medicinal herbs and oseltamivir is more effective than single oseltamivir in treating novel influenza A (H1N1) pneumonia.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Capital Medical University
• Treatments: Oseltamivir

Criteria

Inclusion Criteria:

• Confirmed novel influenza A(H1N1) case with laboratory evidence

• 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:

• Age<14ys or >70ys

• 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