Influenza
Conditions
Keywords
novel influenza A(H1N1), chinese medicinal herbs
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) pneumonia.
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 strain emergence raised increasing concerns. Chinese medicinal herbs, are derived from plants and usually incorporate one or more herbs as the basic drug(s) to treat the disease. The investigators performed RCT to indicate that a combination treatment of Chinese medicinal herbs and oseltamivir is more effective than single oseltamivir in treating novel influenza A (H1N1) pneumonia.
Interventions
DRUGoseltamivir
75mg p.o Bid for 5 days
oseltamivir: 75mg p.o bid for 5 days chinese medicinal herbs:200ml p.o qid for 5 days
Sponsors
Capital Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy rate in 5 days (defined as failure: SaO2<90% at room air or temperature elevated continuously) | two years |
Secondary
| Measure | Time frame |
|---|---|
| Time to resolution of fever(defined as the period from start of study-drug to relief of fever) | two years |
| Time to resolution of respiratory symptoms(defined as the period from start of study-drug to relief of symptoms) | two years |
| Virus shedding time | two years |
| Infiltration resolution of chest radiology | two years |
| SaO2 and PaO2/FiO2(arterial blood gas) | two years |
Countries
China
Contacts
Primary ContactBin Cao, Doctor
Backup ContactLi Gu, Doctor
Outcome results
None listed