Antiviral and Chinese Medicinal Herbs Treatment on Novel Influenza A (H1N1) Virus Infection: Multi-centre, Prospective, Randomized Controlled Study
Overview
- Phase
- Phase 4
- Intervention
- oseltamivir
- Conditions
- Influenza
- Sponsor
- Capital Medical University
- Enrollment
- 102
- Locations
- 1
- Primary Endpoint
- time to resolution of fever (the period from start of study-drug to relief of fever)
- Status
- Completed
- Last Updated
- 16 years ago
Overview
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.
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 Chinese medicinal herbs was effective and safe for treating novel influenza A (H1N1) infection.
Investigators
Eligibility Criteria
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
Arms & Interventions
Oseltamivir
antiviral therapy
Intervention: oseltamivir
chinese medicinary herbs
antiviral therapy
Intervention: chinese medicinal herbs
blank
do not take antiviral therapy
Intervention: blank
oseltalmivir and chinese medicinal herbs
combination antiviral therapy
Intervention: oseltamivir and chinese medicinal herbs
Outcomes
Primary Outcomes
time to resolution of fever (the period from start of study-drug to relief of fever)
Time Frame: one year
Secondary Outcomes
- virus shedding time(one year)
- time to resolution of respiratory symptoms(defined as the period from start of study-drug to relief of symptoms)(one year)