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

Capital Medical University

Status and phase: Unknown; Phase 4

Conditions: Influenza

Treatments: Drug: oseltamivir; Drug: oseltamivir and chinese medicinal herbs

Study type: Interventional

Funder types: Other

Identifiers

NCT00936013

Z09000700090903-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 14 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

oseltamivir

Experimental group

Description:

single antiviral treatment

Treatment:

Drug: oseltamivir

oseltimivir and chinese medicinal herbs

Experimental group

Description:

combination treatment

Treatment:

Drug: oseltamivir and chinese medicinal herbs