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

Not Applicable

• Conditions: Influenza A Virus, H1N1 Subtype
• Interventions: Drug: Chinese herbal medicines plus western therapy; Drug: western therapy

• Registration Number: NCT01053533
• Lead Sponsor: Beijing Ditan Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-01
• Study Start: 2010-01
• Study First Submitted: 2010-01-19
• Study First Submitted QC: 2010-01-20
• Study First Posted: 2010-01-21
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Last Update Submitted: 2010-06-07
• Last Update Posted: 2010-06-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chinese herbal medicines plus western therapy	Chinese herbal medicines plus western therapy	-
western therapy	western therapy	including supportive therapy and antivirus therapy when necessary

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Mao Yu; 🇨🇳 Beijing, Beijing, China