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Clinical Trials/NCT01053533
NCT01053533UnknownNot Applicable

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

Beijing Ditan Hospital1 site in 1 country1,100 target enrollmentStarted: January 2010Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
1,100
Locations
1
Primary Endpoint
incidence of complication
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
6 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Chinese herbal medicines plus western therapy

Experimental

Intervention: Chinese herbal medicines plus western therapy (Drug)

western therapy

Active Comparator

including supportive therapy and antivirus therapy when necessary

Intervention: western therapy (Drug)

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

Secondary Outcomes

  • 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)

Investigators

Sponsor
Beijing Ditan Hospital
Sponsor Class
Other

Study Sites (1)

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