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

Phase 4

• Conditions: Influenza
• Interventions: Drug: oseltamivir and chinese medicinal herbs; Drug: oseltamivir

• Registration Number: NCT00936013
• Lead Sponsor: Capital Medical University

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.

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 Timeline

• Study First Submitted: 2009-07-08
• Study First Submitted QC: 2009-07-08
• Study First Posted: 2009-07-09
• Study Start: 2009-08
• Status Verified: 2009-11
• Last Update Submitted: 2009-11-01
• Last Update Posted: 2009-11-01
• Primary Completion: 2011-07
• Study Completion: 2011-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oseltimivir and chinese medicinal herbs	oseltamivir and chinese medicinal herbs	combination treatment
oseltamivir	oseltamivir	single antiviral treatment

Primary Outcome Measures

Name	Time	Method
Efficacy rate in 5 days (defined as failure: SaO2<90% at room air or temperature elevated continuously)	two years

Secondary Outcome Measures

Name	Time	Method
Time to resolution of fever(defined as the period from start of study-drug to relief of fever)	two years
Time to resolution of respiratory symptoms(defined as the period from start of study-drug to relief of symptoms)	two years
Virus shedding time	two years
Infiltration resolution of chest radiology	two years
SaO2 and PaO2/FiO2(arterial blood gas)	two years

Trial Locations

Locations (1)

Capital Medical University affiliated Bejing Chaoyang Hospital, Beijing Respiratory Medicine Institute; 🇨🇳 Beijing, China