NCT01053533

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,100

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 21, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

June 8, 2010

Status Verified

January 1, 2010

Enrollment Period

3 months

First QC Date

January 19, 2010

Last Update Submit

June 7, 2010

Conditions

Influenza A Virus, H1N1 Subtype

Keywords

Chinese herbal medicinespandemic H1N1 influenzaeffectivenesssafety

Outcome Measures

Primary Outcomes (3)

  • incidence of complication

    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)

    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 Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (2)

Chinese herbal medicines plus western therapy

EXPERIMENTAL
Drug: Chinese herbal medicines plus western therapy

western therapy

ACTIVE COMPARATOR

including supportive therapy and antivirus therapy when necessary

Drug: western therapy

Interventions

Chinese herbal medicines plus western therapyDRUG

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

Chinese herbal medicines plus western therapy
western therapyDRUG

supportive therapy and antivirus therapy when necessary

western therapy

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Suffering from mental illness
  • Attending other clinical studies on influenza
  • Critical pandemic H1N1 influenza patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mao Yu

Beijing, Beijing Municipality, 100015, China

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 19, 2010

First Posted

January 21, 2010

Study Start

January 1, 2010

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

June 8, 2010

Record last verified: 2010-01

Locations

CN(1)