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

Primary Purpose

Influenza

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

oseltamivir

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chinese medicinal herbs

oseltamivir and chinese medicinal herbs

About this trial

This is an interventional treatment trial for Influenza focused on measuring Novel Influenza A(H1N1), Oseltamivir, 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 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

Sites / Locations

Capital Medical University affiliated Beijing Chaoyang Hospital, Beijing Respiratory Medicine Insititute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

blank

Oseltamivir

chinese medicinary herbs

oseltalmivir and chinese medicinal herbs

Arm Description

do not take antiviral therapy

antiviral therapy

combination antiviral therapy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

virus shedding time

Full Information

NCT ID

NCT00935194

First Posted

July 7, 2009

Last Updated

November 30, 2009

Sponsor

Capital Medical University

1. Study Identification

Unique Protocol Identification Number

NCT00935194

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2009

Overall Recruitment Status

Completed

Study Start Date

July 2009 (undefined)

Primary Completion Date

November 2009 (Actual)

Study Completion Date

November 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Capital Medical University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

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), Oseltamivir, 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

102 (Actual)

8. Arms, Groups, and Interventions

Arm Title

blank

Arm Type

Experimental

Arm Description

do not take antiviral therapy

Arm Title

Oseltamivir

Arm Type

Experimental

Arm Description

antiviral therapy

Arm Title

chinese medicinary herbs

Arm Type

Experimental

Arm Description

antiviral therapy

Arm Title

oseltalmivir and chinese medicinal herbs

Arm Type

Experimental

Arm Description

combination antiviral therapy

Intervention Type

Drug

Intervention Name(s)

oseltamivir

Other Intervention Name(s)

TamifluTM

Intervention Description

75mg,bid,for 5 days

Intervention Type

Other

Intervention Name(s)

blank

Intervention Description

no antiviral therapy

Intervention Type

Drug

Intervention Name(s)

chinese medicinal herbs

Intervention Description

200ml,p.o,qid,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

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

Time Frame

one year

Secondary Outcome Measure Information:

Title

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

Time Frame

one year

Title

virus shedding time

Time Frame

one year

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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chen Wang, Doctor

Organizational Affiliation

Capital Medical University affiliated Beijing Chaoyang Hospital, Beijing Respiratory Medicine Insititute

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

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Yu Mao, Doctor

Organizational Affiliation

Beijing Ditan Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Capital Medical University affiliated Beijing Chaoyang Hospital, Beijing Respiratory Medicine Insititute

City

Beijing

ZIP/Postal Code

100020

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

21844547

Citation

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.

Results Reference

derived

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

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