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The purpose of this study is to determine whether Chinese medicinal herbs are effective and safe for treating novel influenza A (H1N1) infection.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| blank | Experimental | do not take antiviral therapy |
|
| Oseltamivir | Experimental | antiviral therapy |
|
| chinese medicinary herbs | Experimental | antiviral therapy |
|
| oseltalmivir and chinese medicinal herbs | Experimental | combination antiviral therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oseltamivir | Drug | 75mg,bid,for 5 days |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| time to resolution of fever (the period from start of study-drug to relief of fever) | one year |
| Measure | Description | Time Frame |
|---|---|---|
| time to resolution of respiratory symptoms(defined as the period from start of study-drug to relief of symptoms) | one year | |
| virus shedding time | one year |
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Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Chen Wang, Doctor | Capital Medical University affiliated Beijing Chaoyang Hospital, Beijing Respiratory Medicine Insititute | Study Chair |
| Qingquan Liu, Docter | Beijing Chinese Traditional Medicine University affiliated Dongzhimen Hospital | Principal Investigator |
| Yu Mao, Doctor | Beijing Ditan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Capital Medical University affiliated Beijing Chaoyang Hospital, Beijing Respiratory Medicine Insititute | Beijing | 100020 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21844547 | Derived | 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. |
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| blank | Other | no antiviral therapy |
|
| chinese medicinal herbs | Drug | 200ml,p.o,qid,for 5 days |
|
| oseltamivir and chinese medicinal herbs | Drug | oseltamivir:75mg,p.o,bid,for 5 days; chinese medicinal herbs:200ml,p.o,qid,for 5 days |
|
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D053139 | Oseltamivir |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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