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Status unknownNCT00936013Updated Nov 1, 2009

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

A Phase 4 interventional study of oseltamivir and oseltamivir and chinese medicinal herbs in Influenza, sponsored by Capital Medical University. Status unknown at 1 site in China. Open to participants aged 14 Years to 70 Years. Per ClinicalTrials.gov, last updated 2009-11-01.

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

The sponsor has not verified this record recently (last verified Nov 2009), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
14 Years to 70 Years
Sex
All
01

Study 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.

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

02

Conditions studied

  • Influenza

Keywords

  • novel influenza A(H1N1)
  • 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 planned enrollment of 400 is above 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 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

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
05

Study design

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

Study arms

  • Experimental
    oseltamivir

    single antiviral treatment

    Drug: oseltamivir

  • Experimental
    oseltimivir and chinese medicinal herbs

    combination treatment

    Drug: oseltamivir and chinese medicinal herbs

Interventions

  • Drugoseltamivir

    75mg p.o Bid for 5 days

    Also known as: Tamiflu

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

    Time frame: two years

Secondary outcomes

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

    Time frame: two years

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

    Time frame: two years

  3. Virus shedding time

    Time frame: two years

  4. Infiltration resolution of chest radiology

    Time frame: two years

  5. SaO2 and PaO2/FiO2(arterial blood gas)

    Time frame: two years

07

Study locations

1 of 1 sites recruiting
  • Capital Medical University affiliated Bejing Chaoyang Hospital, Beijing Respiratory Medicine Institute
    Beijing, 100020, China
    • Bin Cao, Doctor · Contact · caobin1999@gmail.com · 86-010-85231167
    • Bin Cao, Doctor · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00936013
Lead sponsor
Capital Medical University
First posted
Jul 9, 2009
Start date
Aug 2009
Primary completion
Jul 2011 (estimated)
Completion
Jul 2011 (estimated)
Last update
Nov 1, 2009

Study contacts

Bin Cao, Doctor
Contact
caobin1999@gmail.com
86-010-85231999
Li Gu, Doctor
Contact
guliangel@yahoo.com.cn
86-85231133
Chen Wang, Doctor
study chair · Beijing Chao Yang Hospital
Qingquan Liu, Docter
study director · Beijing Chinese Traditional Medicine University affiliated Dongzhimen Hospital
Yu Mao, Doctor
study director · Beijing Ditan Hospital

Oversight

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

Not currently enrolling

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

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