Chinese Medicinal Herbs Treatment on Novel Influenza A (H1N1) : Multi-centre, Prospective, Randomized Controlled Study
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ClinicalTrials.gov Identifier: NCT00935194 |
Recruitment Status
:
Completed
First Posted
: July 8, 2009
Last Update Posted
: December 1, 2009
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Influenza | Drug: oseltamivir Other: blank Drug: chinese medicinal herbs Drug: oseltamivir and chinese medicinal herbs | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 102 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | July 2009 |
Actual Primary Completion Date : | November 2009 |
Actual Study Completion Date : | November 2009 |

Arm | Intervention/treatment |
---|---|
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
|
- time to resolution of fever (the period from start of study-drug to relief of fever) [ Time Frame: one year ]
- 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 ]

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Ages Eligible for Study: | 14 Years to 70 Years (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00935194
China | |
Capital Medical University affiliated Beijing Chaoyang Hospital, Beijing Respiratory Medicine Insititute | |
Beijing, China, 100020 |
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 |
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 |
First Posted: | July 8, 2009 Key Record Dates |
Last Update Posted: | December 1, 2009 |
Last Verified: | November 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 |
Antiviral Agents Oseltamivir Anti-Infective Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |