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

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 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: Flu Flu Shot

Drug Information available for: Oseltamivir Oseltamivir phosphate

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 ]

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 ]
virus shedding time [ Time Frame: one year ]


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 (Child, Adult, Senior)
Sexes Eligible for Study:	All
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Wang C, Cao B, Liu QQ, Zou ZQ, Liang ZA, Gu L, Dong JP, Liang LR, Li XW, Hu K, He XS, Sun YH, An Y, Yang T, Cao ZX, Guo YM, Wen XM, Wang YG, Liu YL, Jiang LD. Oseltamivir compared with the Chinese traditional therapy maxingshigan-yinqiaosan in the treatment of H1N1 influenza: a randomized trial. Ann Intern Med. 2011 Aug 16;155(4):217-25. doi: 10.7326/0003-4819-155-4-201108160-00005. Erratum in: Ann Intern Med. 2012 Jan 3;156(1 Pt 1):71.


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

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	Oseltamivir Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 23, 2017