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

Sponsor:	Capital Medical University
Information provided by:	Capital Medical University
ClinicalTrials.gov Identifier:	NCT00935194

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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 Marijuana

Drug Information available for: Oseltamivir Tamiflu

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
blank: Experimental do not take antiviral therapy	Other: blank no antiviral therapy
Oseltamivir: Experimental antiviral therapy	Drug: oseltamivir 75mg,bid,for 5 days
chinese medicinary herbs: Experimental antiviral therapy	Drug: chinese medicinal herbs 200ml,p.o,qid,for 5 days
oseltalmivir and chinese medicinal herbs: Experimental 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

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

Keywords provided by Capital Medical University:

Novel Influenza A(H1N1)
Oseltamivir
Chinese Medicinal Herbs

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Orthomyxoviridae Infections
Antiviral Agents
Pharmacologic Actions

Oseltamivir
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Therapeutic Uses
Influenza, Human

ClinicalTrials.gov processed this record on February 08, 2010