Chinese Medicinal Herbs Treatment on Novel Influenza A (H1N1) : Multi-centre, Prospective, Randomized Controlled Study
This study has been completed.
Sponsor:
Capital Medical University
Information provided by:
Capital Medical University
ClinicalTrials.gov Identifier:
NCT00935194
First received: July 7, 2009
Last updated: November 30, 2009
Last verified: November 2009
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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:
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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00935194
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 Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases Oseltamivir |
Anti-Infective Agents Antiviral Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on March 01, 2015