Clinical trial NCT00936013: Chinese Medicinal Herbs Treatment on Novel Influenza A (H1N1)Pneumonia: Multi-centre, Prospective, Randomized Controlled Study
Official title: Antiviral and Chinese Medicinal Herbs Treatment on Novel Influenza A (H1N1) Virus Pneumonia: Multi-centre, Prospective, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Influenza
Keywords: novel influenza A(H1N1)
chinese medicinal herbs
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2009-07-09
Enrollment: 400
Sex: ALL
Minimum age (years): 14
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Efficacy rate in 5 days (defined as failure: SaO2<90% at room air or temperature elevated continuously)
timeFrame: two years
Secondary outcomes:
measure: Time to resolution of fever(defined as the period from start of study-drug to relief of fever)
timeFrame: two years
measure: Time to resolution of respiratory symptoms(defined as the period from start of study-drug to relief of symptoms)
timeFrame: two years
measure: Virus shedding time
timeFrame: two years
measure: Infiltration resolution of chest radiology
timeFrame: two years
measure: SaO2 and PaO2/FiO2(arterial blood gas)
timeFrame: two years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Capital Medical University affiliated Bejing Chaoyang Hospital, Beijing Respiratory Medicine Institute
Study officials:
affiliation: Beijing Chao Yang Hospital
name: Chen Wang, Doctor
role: STUDY_CHAIR
affiliation: Beijing Chinese Traditional Medicine University affiliated Dongzhimen Hospital
name: Qingquan Liu, Docter
role: STUDY_DIRECTOR
affiliation: Beijing Ditan Hospital
name: Yu Mao, Doctor
role: STUDY_DIRECTOR
References: