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

This study has been completed.
Sponsor:
Information provided by:
Capital Medical University
ClinicalTrials.gov Identifier:
NCT00935194
First received: July 7, 2009
Last updated: November 30, 2009
Last verified: November 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Influenza
 Drug: oseltamivir
Other: blank
Drug: chinese medicinal herbs
Drug: oseltamivir and chinese medicinal herbs
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Antiviral and Chinese Medicinal Herbs Treatment on Novel Influenza A (H1N1) Virus Infection: Multi-centre, Prospective, Randomized Controlled Study

Resource links provided by NLM:

MedlinePlus related topics: Fever Flu
U.S. FDA Resources

Further study details as provided by Capital Medical University:

Primary Outcome Measures:
  • time to resolution of fever (the period from start of study-drug to relief of fever) [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • time to resolution of respiratory symptoms(defined as the period from start of study-drug to relief of symptoms) [ Time Frame: one year ] [ Designated as safety issue: No ]
  • virus shedding time [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 102
Study Start Date: July 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: blank
do not take antiviral therapy
 Other: blank
no antiviral therapy
Experimental: Oseltamivir
antiviral therapy
 Drug: oseltamivir
75mg,bid,for 5 days
Other Name: TamifluTM
Experimental: chinese medicinary herbs
antiviral therapy
 Drug: chinese medicinal herbs
200ml,p.o,qid,for 5 days
Experimental: oseltalmivir and chinese medicinal herbs
combination antiviral therapy
 Drug: oseltamivir and chinese medicinal herbs
oseltamivir:75mg,p.o,bid,for 5 days; chinese medicinal herbs:200ml,p.o,qid,for 5 days

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.

  Eligibility

Ages Eligible for Study:   14 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00935194

Locations
China
Capital Medical University affiliated Beijing Chaoyang Hospital, Beijing Respiratory Medicine Insititute
Beijing, China, 100020
Sponsors and Collaborators
Capital Medical University
Investigators
Study Chair: Chen Wang, Doctor Capital Medical University affiliated Beijing Chaoyang Hospital, Beijing Respiratory Medicine Insititute
Principal Investigator: Qingquan Liu, Docter Beijing Chinese Traditional Medicine University affiliated Dongzhimen Hospital
Principal Investigator: Yu Mao, Doctor Beijing Ditan Hospital
  More Information

No publications provided by Capital Medical University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Wang Chen, Capital Medical University Affiliated Beijing Chaoyang Hospital
ClinicalTrials.gov Identifier: NCT00935194     History of Changes
Other Study ID Numbers: Z09000700090903
Study First Received: July 7, 2009
Last Updated: November 30, 2009
Health Authority: China: Food and Drug Administration

Keywords provided by Capital Medical University:
Novel Influenza A(H1N1)
Oseltamivir
Chinese Medicinal Herbs

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Antiviral Agents
 Oseltamivir
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013