Clinical trial NCT01053533: A Pragmatic Randomized Controlled Trial of Chinese Herbal Medicine for Severe Pandemic H1N1 Influenza
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Influenza A Virus, H1N1 Subtype
Keywords: Chinese herbal medicines
pandemic H1N1 influenza
effectiveness
safety
Lead sponsor: Beijing Ditan Hospital
Sponsor class: OTHER
Collaborators: name: Beijing University of Chinese Medicine
name: State Administration of Traditional Chinese Medicine of the People's Republic of China
name: China Academy of Chinese Medical Sciences
First posted: 2010-01-21
Enrollment: 1100
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: incidence of complication
timeFrame: 10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients.
measure: mortality of pandemic H1N1 influenza and all-cause mortality(only for severe pandemic H1N1 influenza patients)
timeFrame: 28 days
measure: proportion of deteriorating into severe H1N1 influenza (only for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza)
timeFrame: 10 days
Secondary outcomes:
measure: time to allaying a fever
timeFrame: 10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients
measure: time to symptom relief
timeFrame: 10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients
measure: time and proportion of H1N1 virus turning to negative
timeFrame: 10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients
measure: direct medical cost
timeFrame: 10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients
measure: safety outcome(adverse effects)
timeFrame: 10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients
measure: days in hospital
timeFrame: 10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients
measure: dose and usage of hormones(only for severe pandemic H1N1 influenza patients)
timeFrame: 28 days
measure: Inflammation of lung tissue(only for severe pandemic H1N1 influenza patients)
timeFrame: 28 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Mao Yu
state: Beijing
Study officials:
References: