A Pragmatic Randomized Controlled Trial of Chinese Herbal Medicine for Severe Pandemic H1N1 Influenza (200907001-2A)

Capital Medical University

Status: Unknown

Conditions: Influenza A Virus, H1N1 Subtype

Treatments: Drug: western therapy; Drug: Chinese herbal medicines plus western therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01053533

20100118

Details and patient eligibility

About

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

Enrollment: 1,100 estimated patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,100 participants in 2 patient groups

Chinese herbal medicines plus western therapy

Experimental group

Treatment:

Drug: Chinese herbal medicines plus western therapy

western therapy

Active Comparator group

Description:

including supportive therapy and antivirus therapy when necessary

Treatment:

Drug: western therapy