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

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00935194
• Other study ID #: Z09000700090903
• Status: Completed
• Phase: Phase 4
• First received: July 7, 2009
• Last updated: November 30, 2009
• Start date: July 2009
• Est. completion date: November 2009

Study information

• Verified date: November 2009
• Source: Capital Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether Chinese medicinal herbs are effective and safe for treating novel influenza A (H1N1) infection.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• 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 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 ?-? 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

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,bid,for 5 days

Other:
• blank
no antiviral therapy

Drug:
• chinese medicinal herbs
200ml,p.o,qid,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 Beijing Chaoyang Hospital, Beijing Respiratory Medicine Insititute	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	time to resolution of fever (the period from start of study-drug to relief of fever)		one year	No
Secondary	time to resolution of respiratory symptoms(defined as the period from start of study-drug to relief of symptoms)		one year	No
Secondary	virus shedding time		one year	No