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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Influenza

Intervention / Treatment
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* Drug: oseltamivir
* Drug: oseltamivir and chinese medicinal herbs


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: oseltamivir<br>single antiviral treatment | Drug: oseltamivir<br>* 75mg p.o Bid for 5 days<br>* Other names: Tamiflu;|
| Experimental: oseltimivir and chinese medicinal herbs<br>combination treatment | Drug: oseltamivir and chinese medicinal herbs<br>* oseltamivir: 75mg p.o bid for 5 days chinese medicinal herbs:200ml p.o qid for 5 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy rate in 5 days (defined as failure: SaO2<90% at room air or temperature elevated continuously) |  | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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novel influenza A(H1N1), chinese medicinal herbs