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

Primary Purpose

Influenza

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

oseltamivir

oseltamivir and chinese medicinal herbs

About this trial

This is an interventional treatment trial for Influenza focused on measuring novel influenza A(H1N1), chinese medicinal herbs

Eligibility Criteria

14 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Confirmed novel influenza A(H1N1) case with laboratory evidence
70 ys ≥ age ≥14ys
Within 72hr after the onset of symptoms(body temperature≥37.5℃ with at least one respiratory symptom (cough, sore throat, or nasal symptom)
New lung infiltration showed by chest radiology(x-ray or CT)

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
- 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
- liver function failure: total bilirubin>34μmol/L or ALT/AST ≥3 times normal elevation
Other unappropriated enrollment situations considered by investigator

Sites / Locations

Capital Medical University affiliated Bejing Chaoyang Hospital, Beijing Respiratory Medicine InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

oseltamivir

oseltimivir and chinese medicinal herbs

Arm Description

single antiviral treatment

combination treatment

Outcomes

Primary Outcome Measures

Efficacy rate in 5 days (defined as failure: SaO2<90% at room air or temperature elevated continuously)

Secondary Outcome Measures

Time to resolution of fever(defined as the period from start of study-drug to relief of fever)

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

Virus shedding time

Infiltration resolution of chest radiology

SaO2 and PaO2/FiO2(arterial blood gas)

Full Information

NCT ID

NCT00936013

First Posted

July 8, 2009

Last Updated

November 1, 2009

Sponsor

Capital Medical University

1. Study Identification

Unique Protocol Identification Number

NCT00936013

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2009

Overall Recruitment Status

Unknown status

Study Start Date

August 2009 (undefined)

Primary Completion Date

July 2011 (Anticipated)

Study Completion Date

July 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Capital Medical University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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 a combination treatment of Chinese medicinal herbs and oseltamivir is more effective than single oseltamivir in treating novel influenza A (H1N1) pneumonia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza

Keywords

novel influenza A(H1N1), chinese medicinal herbs

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

oseltamivir

Arm Type

Experimental

Arm Description

single antiviral treatment

Arm Title

oseltimivir and chinese medicinal herbs

Arm Type

Experimental

Arm Description

combination treatment

Intervention Type

Drug

Intervention Name(s)

oseltamivir

Other Intervention Name(s)

Tamiflu

Intervention Description

75mg p.o Bid for 5 days

Intervention Type

Drug

Intervention Name(s)

oseltamivir and chinese medicinal herbs

Intervention Description

oseltamivir: 75mg p.o bid for 5 days chinese medicinal herbs:200ml p.o qid for 5 days

Primary Outcome Measure Information:

Title

Efficacy rate in 5 days (defined as failure: SaO2<90% at room air or temperature elevated continuously)

Time Frame

two years

Secondary Outcome Measure Information:

Title

Time to resolution of fever(defined as the period from start of study-drug to relief of fever)

Time Frame

two years

Title

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

Time Frame

two years

Title

Virus shedding time

Time Frame

two years

Title

Infiltration resolution of chest radiology

Time Frame

two years

Title

SaO2 and PaO2/FiO2(arterial blood gas)

Time Frame

two years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Confirmed novel influenza A(H1N1) case with laboratory evidence 70 ys ≥ age ≥14ys Within 72hr after the onset of symptoms(body temperature≥37.5℃ with at least one respiratory symptom (cough, sore throat, or nasal symptom) New lung infiltration showed by chest radiology(x-ray or CT) 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 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 liver function failure: total bilirubin>34μmol/L or ALT/AST ≥3 times normal elevation Other unappropriated enrollment situations considered by investigator

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Bin Cao, Doctor

Phone

86-010-85231999

caobin1999@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Li Gu, Doctor

Phone

86-85231133

guliangel@yahoo.com.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chen Wang, Doctor

Organizational Affiliation

Beijing Chao Yang Hospital

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Qingquan Liu, Docter

Organizational Affiliation

Beijing Chinese Traditional Medicine University affiliated Dongzhimen Hospital

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Yu Mao, Doctor

Organizational Affiliation

Beijing Ditan Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Capital Medical University affiliated Bejing Chaoyang Hospital, Beijing Respiratory Medicine Institute

City

Beijing

ZIP/Postal Code

100020

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bin Cao, Doctor

Phone

86-010-85231167

caobin1999@gmail.com

First Name & Middle Initial & Last Name & Degree

Bin Cao, Doctor

12. IPD Sharing Statement

Learn more about this trial

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

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