NCT00935194

Brief Summary

The purpose of this study is to determine whether Chinese medicinal herbs are effective and safe for treating novel influenza A (H1N1) infection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2009

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 8, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

December 1, 2009

Status Verified

November 1, 2009

Enrollment Period

4 months

First QC Date

July 7, 2009

Last Update Submit

November 30, 2009

Conditions

Influenza

Keywords

Novel Influenza A(H1N1)OseltamivirChinese Medicinal Herbs

Outcome Measures

Primary Outcomes (1)

  • time to resolution of fever (the period from start of study-drug to relief of fever)

    one year

Secondary Outcomes (2)

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

    one year

  • virus shedding time

    one year

Study Arms (4)

blank

EXPERIMENTAL

do not take antiviral therapy

Other: blank

Oseltamivir

EXPERIMENTAL

antiviral therapy

Drug: oseltamivir

chinese medicinary herbs

EXPERIMENTAL

antiviral therapy

Drug: chinese medicinal herbs

oseltalmivir and chinese medicinal herbs

EXPERIMENTAL

combination antiviral therapy

Drug: oseltamivir and chinese medicinal herbs

Interventions

oseltamivirDRUG

75mg,bid,for 5 days

Also known as: TamifluTM
Oseltamivir
blankOTHER

no antiviral therapy

blank
chinese medicinal herbsDRUG

200ml,p.o,qid,for 5 days

chinese medicinary herbs
oseltamivir and chinese medicinal herbsDRUG

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

oseltalmivir 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
  • years ≥ age ≥ 14years
  • Within 72hr after the onset of symptoms(body temperature≥37.5℃ with at least one respiratory symptom (cough, sore throat, or nasal symptom)

You may not qualify if:

  • Age \< 14 years or \> 70 years
  • Bronchitis, pneumonia, pleural fluid and interstitial infiltration showed by Chest radiology(x-ray or CT)
  • Severe chronic underlying diseases: severe COPD(FEV1/EVC \<70% and FEV1 \<30% predicted or respiratory failure or congestive heart failure), severe hepatic 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
  • hepatic function failure: total bilirubin\>34μmol/L or ALT/AST ≥3 times normal - Other unappropriated enrollment situations considered by investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Capital Medical University affiliated Beijing Chaoyang Hospital, Beijing Respiratory Medicine Insititute

Beijing, 100020, China

Location

Related Publications (1)

  • Wang C, Cao B, Liu QQ, Zou ZQ, Liang ZA, Gu L, Dong JP, Liang LR, Li XW, Hu K, He XS, Sun YH, An Y, Yang T, Cao ZX, Guo YM, Wen XM, Wang YG, Liu YL, Jiang LD. Oseltamivir compared with the Chinese traditional therapy maxingshigan-yinqiaosan in the treatment of H1N1 influenza: a randomized trial. Ann Intern Med. 2011 Aug 16;155(4):217-25. doi: 10.7326/0003-4819-155-4-201108160-00005.

    PMID: 21844547DERIVED

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

    Capital Medical University affiliated Beijing Chaoyang Hospital, Beijing Respiratory Medicine Insititute

    STUDY CHAIR

  • Qingquan Liu, Docter

    Beijing Chinese Traditional Medicine University affiliated Dongzhimen Hospital

    PRINCIPAL INVESTIGATOR

  • Yu Mao, Doctor

    Beijing Ditan Hospital

    PRINCIPAL INVESTIGATOR

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 7, 2009

First Posted

July 8, 2009

Study Start

July 1, 2009

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

December 1, 2009

Record last verified: 2009-11

Locations

CN(1)