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

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

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.

Study Overview

• Status: Unknown
• Conditions: Influenza
• Intervention / Treatment: Drug: oseltamivir; Drug: oseltamivir and chinese medicinal herbs

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 Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100020
    • Recruiting
    • Capital Medical University affiliated Bejing Chaoyang Hospital, Beijing Respiratory Medicine Institute
    • Principal Investigator: Bin Cao, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 70 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: oseltamivir; single antiviral treatment	Drug: oseltamivir; 75mg p.o Bid for 5 days; Other Names: Tamiflu
EXPERIMENTAL: oseltimivir and chinese medicinal herbs; combination treatment	Drug: oseltamivir and chinese medicinal herbs; oseltamivir: 75mg p.o bid for 5 days chinese medicinal herbs:200ml p.o qid for 5 days

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Capital Medical University
• Investigators: Study Chair: Chen Wang, Doctor, Beijing Chao Yang Hospital; Study Director: Qingquan Liu, Docter, Beijing Chinese Traditional Medicine University affiliated Dongzhimen Hospital; Study Director: Yu Mao, Doctor, Beijing Ditan Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (ANTICIPATED): July 1, 2011
• Study Completion (ANTICIPATED): July 1, 2011

Study Registration Dates

• First Submitted: July 8, 2009
• First Submitted That Met QC Criteria: July 8, 2009
• First Posted (ESTIMATE): July 9, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): November 1, 2009
• Last Update Submitted That Met QC Criteria: November 1, 2009
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Keywords: novel influenza A(H1N1); chinese medicinal herbs
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Orthomyxoviridae Infections; Pneumonia; Influenza, Human; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Oseltamivir
• Other Study ID Numbers: Z09000700090903-2