A Pragmatic Randomized Controlled Trial of Chinese Herbal Medicine for Severe Pandemic H1N1 Influenza

Study Overview
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Brief Summary
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The aim of this study is to evaluate the effectiveness and safety of Chinese herbal medicines for severe pandemic H1N1 influenza.

Conditions
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Influenza A Virus, H1N1 Subtype

Intervention / Treatment
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* Drug: Chinese herbal medicines plus western therapy
* Drug: western therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of severe pandemic H1N1 influenza patients and pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza Rapid Diagnostic Tests:positive Age≥6 years Influenza symptoms occurred less than 48 hours and body temperature≥37.5℃ for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza Exclusion Criteria: Suffering from mental illness Attending other clinical studies on influenza Critical pandemic H1N1 influenza patients

Ages Eligible for Study
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Minimum Age: 6 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: Chinese herbal medicines plus western therapy<br> | Drug: Chinese herbal medicines plus western therapy<br>* injections of Chinese herbal medicines and Chinese herbal medicines decoction& supportive therapy and antivirus therapy when necessary<br>|
| Active Comparator: western therapy<br>including supportive therapy and antivirus therapy when necessary | Drug: western therapy<br>* supportive therapy and antivirus therapy when necessary<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of complication |  | 10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients. | 
| mortality of pandemic H1N1 influenza and all-cause mortality(only for severe pandemic H1N1 influenza patients) |  | 28 days | 
| proportion of deteriorating into severe H1N1 influenza (only for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza) |  | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to allaying a fever |  | 10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients | 
| time to symptom relief |  | 10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients | 
| time and proportion of H1N1 virus turning to negative |  | 10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients | 
| direct medical cost |  | 10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients | 
| safety outcome(adverse effects) |  | 10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients | 
| days in hospital |  | 10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients | 
| dose and usage of hormones(only for severe pandemic H1N1 influenza patients) |  | 28 days | 
| Inflammation of lung tissue(only for severe pandemic H1N1 influenza patients) |  | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chinese herbal medicines, pandemic H1N1 influenza, effectiveness, safety