NCT00936013

Brief Summary

The purpose of the study is to determine whether the combination treatment of Chinese medicinal herbs and oseltamivir is more effective than single oseltamivir in treating novel influenza A (H1N1) pneumonia.

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
400

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2009

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 9, 2009

Completed
23 days until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

November 2, 2009

Status Verified

November 1, 2009

Enrollment Period

1.9 years

First QC Date

July 8, 2009

Last Update Submit

November 1, 2009

Conditions

Influenza

Keywords

novel influenza A(H1N1)chinese medicinal herbs

Outcome Measures

Primary Outcomes (1)

  • Efficacy rate in 5 days (defined as failure: SaO2<90% at room air or temperature elevated continuously)

    two years

Secondary Outcomes (5)

  • Time to resolution of fever(defined as the period from start of study-drug to relief of fever)

    two years

  • Time to resolution of respiratory symptoms(defined as the period from start of study-drug to relief of symptoms)

    two years

  • Virus shedding time

    two years

  • Infiltration resolution of chest radiology

    two years

  • SaO2 and PaO2/FiO2(arterial blood gas)

    two years

Study Arms (2)

oseltamivir

EXPERIMENTAL

single antiviral treatment

Drug: oseltamivir

oseltimivir and chinese medicinal herbs

EXPERIMENTAL

combination treatment

Drug: oseltamivir and chinese medicinal herbs

Interventions

oseltamivirDRUG

75mg p.o Bid for 5 days

Also known as: Tamiflu
oseltamivir
oseltamivir and chinese medicinal herbsDRUG

oseltamivir: 75mg p.o bid for 5 days chinese medicinal herbs:200ml p.o qid for 5 days

oseltimivir and chinese medicinal herbs

Eligibility Criteria

Age14 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed novel influenza A(H1N1) case with laboratory evidence
  • ys ≥ age ≥14ys
  • Within 72hr after the onset of symptoms(body temperature≥37.5℃ with at least one respiratory symptom (cough, sore throat, or nasal symptom)
  • New lung infiltration showed by chest radiology(x-ray or CT)

You may not qualify if:

  • Age\<14ys or \>70ys
  • Pregnancy
  • Severe chronic underlying diseases: severe COPD(FEV1/EVC \<70% and FEV1 \<30% predicted or respiratory failure or congestive heart failure), severe liver disfunction（ALT or AST ≥3 times normal elevation), renal disfunction（Cr\>2mg/dL), chronic heart failure(NYHA Ⅲ-Ⅳ grade）
  • Immunocompromised patients(cancer, organ transplant, AIDS and a history of treatment with immunosuppressive drug and glucocorticoids in the past 3 months)
  • Taken Chinese medicinal herbs, antiviral or antibiotic drug in the past 2 weeks
  • Inoculation influenza vaccination
  • One of the following items appeared at the enrollment
  • respiratory failure：PaO2\<60mmHg and/or PCO2\>50mmHg or PaO2/FiO2≤300
  • circulation failure: despite adequate fluid resuscitation and cardiac output, systolic \<90mmHg or requirement inotropic support
  • renal function failure: despite adequate fluid resuscitation and cardiac output, urine ≤ 0.5ml/kg.h, Cr or BUN≥1 time normal elevation
  • liver function failure: total bilirubin\>34μmol/L or ALT/AST ≥3 times normal elevation
  • Other unappropriated enrollment situations considered by investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Capital Medical University affiliated Bejing Chaoyang Hospital, Beijing Respiratory Medicine Institute

Beijing, 100020, China

RECRUITING

MeSH Terms

Conditions

Influenza, Human

Interventions

Oseltamivir

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbons

Study Officials

  • Chen Wang, Doctor

    Beijing Chao Yang Hospital

    STUDY CHAIR

  • Qingquan Liu, Docter

    Beijing Chinese Traditional Medicine University affiliated Dongzhimen Hospital

    STUDY DIRECTOR

  • Yu Mao, Doctor

    Beijing Ditan Hospital

    STUDY DIRECTOR

Central Study Contacts

Bin Cao, Doctor

CONTACT

86-010-85231999caobin1999@gmail.com

Li Gu, Doctor

CONTACT

86-85231133guliangel@yahoo.com.cn

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 8, 2009

First Posted

July 9, 2009

Study Start

August 1, 2009

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

November 2, 2009

Record last verified: 2009-11

Locations

CN(1)