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A Pragmatic Randomized Controlled Trial of Chinese Herbal Medicine for Severe Pandemic H1N1 Influenza (200907001-2A)

Primary Purpose

Influenza A Virus, H1N1 Subtype

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Chinese herbal medicines plus western therapy

western therapy

About this trial

This is an interventional treatment trial for Influenza A Virus, H1N1 Subtype focused on measuring Chinese herbal medicines, pandemic H1N1 influenza, effectiveness, safety

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Mao YuRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Chinese herbal medicines plus western therapy

western therapy

Arm Description

including supportive therapy and antivirus therapy when necessary

Outcomes

Primary Outcome Measures

incidence of complication

mortality of pandemic H1N1 influenza and all-cause mortality(only for severe pandemic H1N1 influenza patients)

proportion of deteriorating into severe H1N1 influenza (only for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza)

Secondary Outcome Measures

time to allaying a fever

time to symptom relief

time and proportion of H1N1 virus turning to negative

direct medical cost

safety outcome(adverse effects)

days in hospital

dose and usage of hormones(only for severe pandemic H1N1 influenza patients)

Inflammation of lung tissue(only for severe pandemic H1N1 influenza patients)

Full Information

NCT ID

NCT01053533

First Posted

January 19, 2010

Last Updated

June 7, 2010

Sponsor

Beijing Ditan Hospital

Collaborators

Beijing University of Chinese Medicine, State Administration of Traditional Chinese Medicine of the People's Republic of China, China Academy of Chinese Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT01053533

Brief Title

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

Acronym

200907001-2A

Study Type

Interventional

2. Study Status

Record Verification Date

January 2010

Overall Recruitment Status

Unknown status

Study Start Date

January 2010 (undefined)

Primary Completion Date

April 2010 (Anticipated)

Study Completion Date

April 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Beijing Ditan Hospital

Collaborators

Beijing University of Chinese Medicine, State Administration of Traditional Chinese Medicine of the People's Republic of China, China Academy of Chinese Medical Sciences

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza A Virus, H1N1 Subtype

Keywords

Chinese herbal medicines, pandemic H1N1 influenza, effectiveness, safety

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Chinese herbal medicines plus western therapy

Arm Type

Experimental

Arm Title

western therapy

Arm Type

Active Comparator

Arm Description

including supportive therapy and antivirus therapy when necessary

Intervention Type

Drug

Intervention Name(s)

Chinese herbal medicines plus western therapy

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

western therapy

Intervention Description

supportive therapy and antivirus therapy when necessary

Primary Outcome Measure Information:

Title

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.

Title

mortality of pandemic H1N1 influenza and all-cause mortality(only for severe pandemic H1N1 influenza patients)

Time Frame

28 days

Title

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 Outcome Measure Information:

Title

time to allaying a fever

Time Frame