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Chinese Medicinal Herbs Treatment on Novel Influenza A (H1N1)Pneumonia: Multi-centre, Prospective, Randomized Controlled Study

Sponsor
Capital Medical University (Other)
Overall Status
Unknown status
CT.gov ID
NCT00936013
Collaborator
(none)
400
Enrollment
1
Location
2
Arms
23
Duration (Months)
17.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

The antiviral agent, oseltamivir, is recommended by the World Health Organization (WHO) to treat recent outbreak novel influenza A (H1N1) virus infection around world. But limited stock and resistant strain emergence raised increasing concerns. Chinese medicinal herbs, are derived from plants and usually incorporate one or more herbs as the basic drug(s) to treat the disease. The investigators performed RCT to indicate that a combination treatment of Chinese medicinal herbs and oseltamivir is more effective than single oseltamivir in treating novel influenza A (H1N1) pneumonia.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Antiviral and Chinese Medicinal Herbs Treatment on Novel Influenza A (H1N1) Virus Pneumonia: Multi-centre, Prospective, Randomized Controlled Study
Study Start Date :
Aug 1, 2009
Anticipated Primary Completion Date :
Jul 1, 2011
Anticipated Study Completion Date :
Jul 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: oseltamivir

single antiviral treatment

Drug: oseltamivir
75mg p.o Bid for 5 days
Other Names:
  • Tamiflu

    		•
    Experimental: oseltimivir and chinese medicinal herbs

    combination treatment

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

    Outcome Measures

    Primary Outcome Measures

    1. Efficacy rate in 5 days (defined as failure: SaO2<90% at room air or temperature elevated continuously) [two years]

    Secondary Outcome Measures

    1. Time to resolution of fever(defined as the period from start of study-drug to relief of fever) [two years]

    2. Time to resolution of respiratory symptoms(defined as the period from start of study-drug to relief of symptoms) [two years]

    3. Virus shedding time [two years]

    4. Infiltration resolution of chest radiology [two years]

    5. SaO2 and PaO2/FiO2(arterial blood gas) [two years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    14 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Confirmed novel influenza A(H1N1) case with laboratory evidence

    • 70 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)

    Exclusion Criteria:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Capital Medical University affiliated Bejing Chaoyang Hospital, Beijing Respiratory Medicine Institute Beijing China 100020

    Sponsors and Collaborators

    • Capital Medical University

    Investigators

    • Study Chair: Chen Wang, Doctor, Beijing Chao Yang Hospital
    • Study Director: Qingquan Liu, Docter, Beijing Chinese Traditional Medicine University affiliated Dongzhimen Hospital
    • Study Director: Yu Mao, Doctor, Beijing Ditan Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00936013
    Other Study ID Numbers:
    • Z09000700090903-2
    First Posted:
    Jul 9, 2009
    Last Update Posted:
    Nov 1, 2009
    Last Verified:
    Nov 1, 2009
    Keywords provided by , ,
    novel influenza A(H1N1)
    chinese medicinal herbs
    Additional relevant MeSH terms:
    Influenza, Human
    Pneumonia
    Oseltamivir

    Study Results

    No Results Posted as of Nov 1, 2009