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CompletedNCT00935194Updated Dec 1, 2009

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

A Phase 4 interventional study of oseltamivir and blank in Influenza, sponsored by Capital Medical University. Completed at 1 site in China. Open to participants aged 14 Years to 70 Years. Per ClinicalTrials.gov, last updated 2009-12-01.

Sponsored by Capital Medical University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
102
Allocation
Randomized
Ages
14 Years to 70 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Influenza

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Keywords

  • Novel Influenza A(H1N1)
  • Oseltamivir
  • Chinese Medicinal Herbs
03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 164 are open to participants now.

This study's enrollment of 102 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

Capital Medical University is the lead sponsor of 283 studies on the registry; 92 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 70 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
102 participants (actual)

Study arms

  • Experimental
    blank

    do not take antiviral therapy

    Other: blank

  • Experimental
    Oseltamivir

    antiviral therapy

    Drug: oseltamivir

  • Experimental
    chinese medicinary herbs

    antiviral therapy

    Drug: chinese medicinal herbs

  • Experimental
    oseltalmivir and chinese medicinal herbs

    combination antiviral therapy

    Drug: oseltamivir and chinese medicinal herbs

Interventions

  • Drugoseltamivir

    75mg,bid,for 5 days

    Also known as: TamifluTM

  • Otherblank

    no antiviral therapy

  • Drugchinese medicinal herbs

    200ml,p.o,qid,for 5 days

  • Drugoseltamivir and chinese medicinal herbs

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

06

What researchers measure

Primary outcomes

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

    Time frame: one year

Secondary outcomes

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

    Time frame: one year

  2. virus shedding time

    Time frame: one year

07

Study locations

1 site
  • Capital Medical University affiliated Beijing Chaoyang Hospital, Beijing Respiratory Medicine Insititute
    Beijing, 100020, China
08

References and documents

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. PubMed 21844547 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 1, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00935194
Lead sponsor
Capital Medical University
First posted
Jul 8, 2009
Start date
Jul 2009
Primary completion
Nov 2009
Completion
Nov 2009
Last update
Dec 1, 2009

Study contacts

Chen Wang, Doctor
study chair · Capital Medical University affiliated Beijing Chaoyang Hospital, Beijing Respiratory Medicine Insititute
Qingquan Liu, Docter
principal investigator · Beijing Chinese Traditional Medicine University affiliated Dongzhimen Hospital
Yu Mao, Doctor
principal investigator · Beijing Ditan Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2009. You cannot join it, but the record below documents what was studied.

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