InfluenzaPhase 4NCT00936013
Chinese Medicinal Herbs Treatment on Novel Influenza A (H1N1)Pneumonia: Multi-centre, Prospective, Randomized Controlled Study
A Phase 4 study testing oseltamivir and oseltamivir and chinese medicinal herbs in people with Influenza, run by Capital Medical University at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 14 to 70 years
- Conditions the study is for
- Influenza
- What is being tested?
- oseltamivir and oseltamivir and chinese medicinal herbs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- Aug 2009to Jul 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Capital Medical University affiliated Bejing Chaoyang Hospital, Beijing Respiratory Medicine Institute
Beijing, 100020
Bin Cao, Doctor, 86-010-85231167, caobin1999@gmail.com
Bin Cao, Doctor
About this study
Official title: Antiviral and Chinese Medicinal Herbs Treatment on Novel Influenza A (H1N1) Virus Pneumonia: Multi-centre, Prospective, Randomized Controlled Study
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.
- Conditions
- Influenza
- Being tested
- oseltamivir, oseltamivir and chinese medicinal herbs
- Keywords
- novel influenza A(H1N1), chinese medicinal herbs
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oseltamivirDrug
Also called Tamiflu
75mg p.o Bid for 5 days
oseltamivir and chinese medicinal herbsDrug
oseltamivir: 75mg p.o bid for 5 days chinese medicinal herbs:200ml p.o qid for 5 days
| Study group | Role | What they receive |
|---|---|---|
| oseltamivir | Experimental | single antiviral treatment Receives: Drug: oseltamivir |
| oseltimivir and chinese medicinal herbs | Experimental | combination treatment Receives: Drug: oseltamivir and chinese medicinal herbs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy rate in 5 days (defined as failure: SaO2<90% at room air or temperature elevated continuously)
Measured: two years
Secondary outcomes (5)
Time to resolution of fever(defined as the period from start of study-drug to relief of fever)
Measured: two years
Time to resolution of respiratory symptoms(defined as the period from start of study-drug to relief of symptoms)
Measured: two years
Virus shedding time
Measured: two years
Infiltration resolution of chest radiology
Measured: two years
SaO2 and PaO2/FiO2(arterial blood gas)
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2009 (estimated)
- Study startAug 2009
- Primary completionJul 2011 (estimated)
- Study completionJul 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Investigators
- Chen Wang, Doctor, Study chair, Beijing Chao Yang HospitalQingquan Liu, Docter, Study director, Beijing Chinese Traditional Medicine University affiliated Dongzhimen HospitalYu Mao, Doctor, Study director, Beijing Ditan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00936013
- Sponsor's protocol ID
- Z09000700090903-2
- Status last verified
- Nov 2009
- First submitted
- 8 Jul 2009
- Last updated
- 2 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antiviral and Chinese Medicinal Herbs Treatment on Novel Influenza A (H1N1) Virus Pneumonia: Multi-centre, Prospective, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT00936013
- Acronym / sponsor ID
- Z09000700090903-2
- Conditions
- Influenza
- Keywords
- novel influenza A(H1N1), chinese medicinal herbs
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Jul 2011 (estimated)
- Study completion
- Jul 2011 (estimated)
- First posted
- 9 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oseltamivir | Experimental | Drug: oseltamivirsingle antiviral treatment |
| oseltimivir and chinese medicinal herbs | Experimental | Drug: oseltamivir and chinese medicinal herbscombination treatment |
Who may qualify
- Ages
- 14 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oseltamivirAlso: Tamiflu75mg p.o Bid for 5 days | Drug | oseltamivir |
| oseltamivir and chinese medicinal herbsoseltamivir: 75mg p.o bid for 5 days chinese medicinal herbs:200ml p.o qid for 5 days | Drug | oseltimivir and chinese medicinal herbs |
Primary outcome
Efficacy rate in 5 days (defined as failure: SaO2<90% at room air or temperature elevated continuously)
Time frame: two years
5 secondary outcomes
Time to resolution of fever(defined as the period from start of study-drug to relief of fever)
Time frame: two years
Time to resolution of respiratory symptoms(defined as the period from start of study-drug to relief of symptoms)
Time frame: two years
Virus shedding time
Time frame: two years
Infiltration resolution of chest radiology
Time frame: two years
SaO2 and PaO2/FiO2(arterial blood gas)
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing oseltamivir and oseltamivir and chinese medicinal herbs in people with Influenza, run by Capital Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bin Cao, Doctor (86-010-85231999, caobin1999@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy rate in 5 days (defined as failure: SaO2<90% at room air or temperature elevated continuously) (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2009.