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

This study has been completed.
Sponsor:
Information provided by:
Capital Medical University
ClinicalTrials.gov Identifier:
NCT00935194
First received: July 7, 2009
Last updated: November 30, 2009
Last verified: November 2009

July 7, 2009
November 30, 2009
July 2009
November 2009   (final data collection date for primary outcome measure)
time to resolution of fever (the period from start of study-drug to relief of fever) [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00935194 on ClinicalTrials.gov Archive Site
  • time to resolution of respiratory symptoms(defined as the period from start of study-drug to relief of symptoms) [ Time Frame: one year ] [ Designated as safety issue: No ]
  • virus shedding time [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Chinese Medicinal Herbs Treatment on Novel Influenza A (H1N1) : Multi-centre, Prospective, Randomized Controlled Study
Antiviral and Chinese Medicinal Herbs Treatment on Novel Influenza A (H1N1) Virus Infection: Multi-centre, Prospective, Randomized Controlled Study

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

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 Chinese medicinal herbs was effective and safe for treating novel influenza A (H1N1) infection.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Influenza
  • Drug: oseltamivir
    75mg,bid,for 5 days
    Other Name: TamifluTM
  • Other: blank
    no antiviral therapy
  • Drug: chinese medicinal herbs
    200ml,p.o,qid,for 5 days
  • Drug: oseltamivir and chinese medicinal herbs
    oseltamivir:75mg,p.o,bid,for 5 days; chinese medicinal herbs:200ml,p.o,qid,for 5 days
  • Experimental: blank
    do not take antiviral therapy
    Intervention: Other: blank
  • Experimental: Oseltamivir
    antiviral therapy
    Intervention: Drug: oseltamivir
  • Experimental: chinese medicinary herbs
    antiviral therapy
    Intervention: Drug: chinese medicinal herbs
  • Experimental: oseltalmivir and chinese medicinal herbs
    combination antiviral therapy
    Intervention: Drug: oseltamivir and chinese medicinal herbs
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. Erratum in: Ann Intern Med. 2012 Jan 3;156(1 Pt 1):71.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
102
November 2009
November 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Confirmed novel influenza A(H1N1) case with laboratory evidence
  • 70 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)

Exclusion Criteria:

  • 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
Both
14 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00935194
Z09000700090903
Yes
Wang Chen, Capital Medical University Affiliated Beijing Chaoyang Hospital
Capital Medical University
Not Provided
Study Chair: Chen Wang, Doctor Capital Medical University affiliated Beijing Chaoyang Hospital, Beijing Respiratory Medicine Insititute
Principal Investigator: Qingquan Liu, Docter Beijing Chinese Traditional Medicine University affiliated Dongzhimen Hospital
Principal Investigator: Yu Mao, Doctor Beijing Ditan Hospital
Capital Medical University
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP