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

Phase 4

Completed

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

• Registration Number: NCT00935194
• Lead Sponsor: Capital Medical University

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.

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-07
• Study First Submitted QC: 2009-07-07
• Study First Posted: 2009-07-08
• Status Verified: 2009-11
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Last Update Submitted: 2009-11-30
• Last Update Posted: 2009-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
chinese medicinary herbs	chinese medicinal herbs	antiviral therapy
oseltalmivir and chinese medicinal herbs	oseltamivir and chinese medicinal herbs	combination antiviral therapy
blank	blank	do not take antiviral therapy
Oseltamivir	oseltamivir	antiviral therapy

Primary Outcome Measures

Name	Time	Method
time to resolution of fever (the period from start of study-drug to relief of fever)	one year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

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