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

Beijing Ditan Hospital1,100 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,100

Conditions

Influenza A Virus, H1N1 Subtype

Interventions

Chinese herbal medicines plus western therapyDRUG

injections of Chinese herbal medicines and Chinese herbal medicines decoction\& supportive therapy and antivirus therapy when necessary

western therapyDRUG

supportive therapy and antivirus therapy when necessary

Eligibility

Sex: ALLMin age: 6 Years

Medical Language ↔ Plain English

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

Locations (1)

Mao Yu

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

incidence of complication

Time frame: 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)

Time frame: 28 days

proportion of deteriorating into severe H1N1 influenza (only for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza)

Time frame: 10 days