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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01053533
Acronym
200907001-2A
Enrollment
1100
Registered
2010-01-21
Start date
2010-01-31
Completion date
2010-04-30
Last updated
2010-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza A Virus, H1N1 Subtype

Keywords

Chinese herbal medicines, pandemic H1N1 influenza, effectiveness, safety

Brief summary

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

Interventions

DRUGChinese herbal medicines plus western therapy

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

DRUGwestern therapy

supportive therapy and antivirus therapy when necessary

Sponsors

Beijing University of Chinese Medicine
CollaboratorOTHER
State Administration of Traditional Chinese Medicine of the People's Republic of China
CollaboratorOTHER_GOV
China Academy of Chinese Medical Sciences
CollaboratorOTHER
Beijing Ditan Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
incidence of complication10 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

MeasureTime frame
direct medical cost10 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
time to allaying a fever10 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
days in hospital10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients
time to symptom relief10 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 negative10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026