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

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00936013
• Other study ID #: Z09000700090903-2
• Status: Recruiting
• Phase: Phase 4
• First received: July 8, 2009
• Last updated: November 1, 2009
• Start date: August 2009
• Est. completion date: July 2011

Study information

• Verified date: November 2009
• Source: Capital Medical University
• Contact: Bin Cao, Doctor
• Phone: 86-010-85231999
• Email: caobin1999[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 70 Years

Eligibility

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 ?-? 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Drug:
• oseltamivir
75mg p.o Bid for 5 days
• oseltamivir and chinese medicinal herbs
oseltamivir: 75mg p.o bid for 5 days chinese medicinal herbs:200ml p.o qid for 5 days

Locations

Country	Name	City	State
China	Capital Medical University affiliated Bejing Chaoyang Hospital, Beijing Respiratory Medicine Institute	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy rate in 5 days (defined as failure: SaO2<90% at room air or temperature elevated continuously)		two years	No
Secondary	Time to resolution of fever(defined as the period from start of study-drug to relief of fever)		two years	No
Secondary	Time to resolution of respiratory symptoms(defined as the period from start of study-drug to relief of symptoms)		two years	No
Secondary	Virus shedding time		two years	No
Secondary	Infiltration resolution of chest radiology		two years	No
Secondary	SaO2 and PaO2/FiO2(arterial blood gas)		two years	No