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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Capital Medical University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Capital Medical University
ClinicalTrials.gov Identifier:
NCT00936013
First received: July 8, 2009
Last updated: November 1, 2009
Last verified: November 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Influenza
 Drug: oseltamivir
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 Pneumonia: Multi-centre, Prospective, Randomized Controlled Study

Resource links provided by NLM:

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

Further study details as provided by Capital Medical University:

Primary Outcome Measures:
  • Efficacy rate in 5 days (defined as failure: SaO2<90% at room air or temperature elevated continuously) [ Time Frame: two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to resolution of fever(defined as the period from start of study-drug to relief of fever) [ Time Frame: two years ] [ Designated as safety issue: No ]
  • Time to resolution of respiratory symptoms(defined as the period from start of study-drug to relief of symptoms) [ Time Frame: two years ] [ Designated as safety issue: No ]
  • Virus shedding time [ Time Frame: two years ] [ Designated as safety issue: No ]
  • Infiltration resolution of chest radiology [ Time Frame: two years ] [ Designated as safety issue: No ]
  • SaO2 and PaO2/FiO2(arterial blood gas) [ Time Frame: two years ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: August 2009
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: oseltamivir
single antiviral treatment
 Drug: oseltamivir
75mg p.o Bid for 5 days
Other Name: 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

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

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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00936013

Contacts
Contact: Bin Cao, Doctor 86-010-85231999 caobin1999@gmail.com
Contact: Li Gu, Doctor 86-85231133 guliangel@yahoo.com.cn

Locations
China
Capital Medical University affiliated Bejing Chaoyang Hospital, Beijing Respiratory Medicine Institute Recruiting
Beijing, China, 100020
Contact: Bin Cao, Doctor     86-010-85231167     caobin1999@gmail.com    
Principal Investigator: Bin Cao, Doctor            
Sponsors and Collaborators
Capital Medical University
Investigators
Study Chair: Chen Wang, Doctor Beijing Chaoyang Hospital
Study Director: Qingquan Liu, Docter Beijing Chinese Traditional Medicine University affiliated Dongzhimen Hospital
Study Director: Yu Mao, Doctor Beijing Ditan Hospital
  More Information

No publications provided

Responsible Party: Wang Chen, Capital Medical University affiliated Beijing Chaoyang Hospital
ClinicalTrials.gov Identifier: NCT00936013     History of Changes
Other Study ID Numbers: Z09000700090903－2
Study First Received: July 8, 2009
Last Updated: November 1, 2009
Health Authority: China: Food and Drug Administration

Keywords provided by Capital Medical University:
novel influenza A(H1N1)
chinese medicinal herbs

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

ClinicalTrials.gov processed this record on May 23, 2013