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

Study Overview
=================
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 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 Chinese medicinal herbs was effective and safe for treating novel influenza A (H1N1) infection.

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

Conditions
-----------------
Influenza

Intervention / Treatment
-----------------
* Drug: oseltamivir
* Other: blank
* Drug: chinese medicinal herbs
* Drug: oseltamivir and chinese medicinal herbs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Criteria: 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

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: blank<br>do not take antiviral therapy | Other: blank<br>* no antiviral therapy<br>|
| Experimental: Oseltamivir<br>antiviral therapy | Drug: oseltamivir<br>* 75mg,bid,for 5 days<br>* Other names: TamifluTM;|
| Experimental: chinese medicinary herbs<br>antiviral therapy | Drug: chinese medicinal herbs<br>* 200ml,p.o,qid,for 5 days<br>|
| Experimental: oseltalmivir and chinese medicinal herbs<br>combination antiviral therapy | 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?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to resolution of fever (the period from start of study-drug to relief of fever) |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to resolution of respiratory symptoms(defined as the period from start of study-drug to relief of symptoms) |  | one year | 
| virus shedding time |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Novel Influenza A(H1N1), Chinese Medicinal Herbs, Oseltamivir