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

NCT ID: NCT01053533

Last Updated: 2010-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-04-30

Brief Summary

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

Detailed Description

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Conditions

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Influenza A Virus, H1N1 Subtype

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Chinese herbal medicines plus western therapy

Group Type EXPERIMENTAL

Chinese herbal medicines plus western therapy

Intervention Type DRUG

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

western therapy

including supportive therapy and antivirus therapy when necessary

Group Type ACTIVE_COMPARATOR

western therapy

Intervention Type DRUG

supportive therapy and antivirus therapy when necessary

Interventions

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Chinese herbal medicines plus western therapy

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

Intervention Type DRUG

western therapy

supportive therapy and antivirus therapy when necessary

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing University of Chinese Medicine

OTHER

Sponsor Role collaborator

State Administration of Traditional Chinese Medicine of the People's Republic of China

OTHER_GOV

Sponsor Role collaborator

China Academy of Chinese Medical Sciences

OTHER

Sponsor Role collaborator

Beijing Ditan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Beijing Di Tan Hospital

Locations

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Mao Yu

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Yu Mao

Role: primary

Guang Yu Wang

Role: backup

Other Identifiers

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20100118

Identifier Type: -

Identifier Source: org_study_id

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