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

Information source: Capital Medical University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Influenza

Intervention: oseltamivir (Drug); blank (Other); chinese medicinal herbs (Drug); oseltamivir and chinese medicinal herbs (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Capital Medical University

Official(s) and/or principal investigator(s):
Chen Wang, Doctor, Study Chair, Affiliation: Capital Medical University affiliated Beijing Chaoyang Hospital, Beijing Respiratory Medicine Insititute
Qingquan Liu, Docter, Principal Investigator, Affiliation: Beijing Chinese Traditional Medicine University affiliated Dongzhimen Hospital
Yu Mao, Doctor, Principal Investigator, Affiliation: Beijing Ditan Hospital

Summary

The purpose of this study is to determine whether Chinese medicinal herbs are effective and safe for treating novel influenza A (H1N1) infection.

Clinical Details

Official title: Antiviral and Chinese Medicinal Herbs Treatment on Novel Influenza A (H1N1) Virus Infection: Multi-centre, Prospective, Randomized Controlled Study

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: time to resolution of fever (the period from start of study-drug to relief of fever)

Secondary outcome:

time to resolution of respiratory symptoms(defined as the period from start of study-drug to relief of symptoms)

virus shedding time

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

Minimum age: 14 Years. Maximum age: 70 Years. Gender(s): Both.

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

Locations and Contacts

Capital Medical University affiliated Beijing Chaoyang Hospital, Beijing Respiratory Medicine Insititute, Beijing 100020, China
Additional Information

Starting date: July 2009
Last updated: November 30, 2009

Page last updated: August 23, 2015

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