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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oseltamivir | Experimental | single antiviral treatment |
|
| oseltimivir and chinese medicinal herbs | Experimental | combination treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oseltamivir | Drug | 75mg p.o Bid for 5 days |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy rate in 5 days (defined as failure: SaO2<90% at room air or temperature elevated continuously) | two years |
| Measure | Description | Time Frame |
|---|---|---|
| Time to resolution of fever(defined as the period from start of study-drug to relief of fever) | two years | |
| Time to resolution of respiratory symptoms(defined as the period from start of study-drug to relief of symptoms) | two years |
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Inclusion Criteria:
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
Other unappropriated enrollment situations considered by investigator
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bin Cao, Doctor | Contact | 86-010-85231999 | caobin1999@gmail.com | |
| Li Gu, Doctor | Contact | 86-85231133 | guliangel@yahoo.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Chen Wang, Doctor | Beijing Chao Yang Hospital | Study Chair |
| Qingquan Liu, Docter | Beijing Chinese Traditional Medicine University affiliated Dongzhimen Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Capital Medical University affiliated Bejing Chaoyang Hospital, Beijing Respiratory Medicine Institute | Recruiting | Beijing | 100020 | China |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D053139 | Oseltamivir |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 |
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| oseltamivir and chinese medicinal herbs | Drug | oseltamivir: 75mg p.o bid for 5 days chinese medicinal herbs:200ml p.o qid for 5 days |
|
| Virus shedding time | two years |
| Infiltration resolution of chest radiology | two years |
| SaO2 and PaO2/FiO2(arterial blood gas) | two years |
| Yu Mao, Doctor |
| Beijing Ditan Hospital |
| Study Director |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |