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

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

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

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Other: blank; Drug: oseltamivir; Drug: chinese medicinal herbs; Drug: oseltamivir and chinese medicinal herbs

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.

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 70 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
time to resolution of fever (the period from start of study-drug to relief of fever)	one year

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Capital Medical University
• Investigators: Principal Investigator: Qingquan Liu, Docter, Beijing Chinese Traditional Medicine University affiliated Dongzhimen Hospital; Principal Investigator: Yu Mao, Doctor, Beijing Ditan Hospital

Publications and helpful links

General Publications

• 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. Erratum In: Ann Intern Med. 2012 Jan 3;156(1 Pt 1):71.

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (ACTUAL): November 1, 2009
• Study Completion (ACTUAL): November 1, 2009

Study Registration Dates

• First Submitted: July 7, 2009
• First Submitted That Met QC Criteria: July 7, 2009
• First Posted (ESTIMATE): July 8, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): December 1, 2009
• Last Update Submitted That Met QC Criteria: November 30, 2009
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Keywords: Oseltamivir; Novel Influenza A(H1N1); Chinese Medicinal Herbs
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Oseltamivir
• Other Study ID Numbers: Z09000700090903