Status:
UNKNOWN
Chinese Medicinal Herbs Treatment on Novel Influenza A (H1N1)Pneumonia: 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 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) pne...
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 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
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2011
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00936013
Start Date
August 1 2009
End Date
July 1 2011
Last Update
November 2 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Capital Medical University affiliated Bejing Chaoyang Hospital, Beijing Respiratory Medicine Institute
Beijing, China, 100020