InfluenzaPhase 4NCT00935194
Chinese Medicinal Herbs Treatment on Novel Influenza A (H1N1) : Multi-centre, Prospective, Randomized Controlled Study
A Phase 4 study testing oseltamivir, blank and chinese medicinal herbs in people with Influenza, run by Capital Medical University at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 14 to 70 years
- Conditions the study is for
- Influenza
- What is being tested?
- oseltamivir, blank and chinese medicinal herbs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- Jul 2009to Nov 2009
- 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 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)
Who cannot join
- 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
Show all 11Show 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
- hepatic function failure: total bilirubin>34μmol/L or ALT/AST ≥3 times normal - Other unappropriated enrollment situations considered by investigator
Trial locations and contacts
1 site in 1 country.
China1 site
Capital Medical University affiliated Beijing Chaoyang Hospital, Beijing Respiratory Medicine Insititute
Beijing, 100020
About this study
Official title: Antiviral and Chinese Medicinal Herbs Treatment on Novel Influenza A (H1N1) Virus Infection: Multi-centre, Prospective, Randomized Controlled Study
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.
- Conditions
- Influenza
- Being tested
- oseltamivir, blank, chinese medicinal herbs, oseltamivir and chinese medicinal herbs
- Keywords
- Novel Influenza A(H1N1), Oseltamivir, 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 TamifluTM
75mg,bid,for 5 days
blankOther
no antiviral therapy
chinese medicinal herbsDrug
200ml,p.o,qid,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 |
|---|---|---|
| blank | Experimental | do not take antiviral therapy Receives: Other: blank |
| Oseltamivir | Experimental | antiviral therapy Receives: Drug: oseltamivir |
| chinese medicinary herbs | Experimental | antiviral therapy Receives: Drug: chinese medicinal herbs |
| oseltalmivir and chinese medicinal herbs | Experimental | combination antiviral therapy Receives: Drug: oseltamivir and chinese medicinal herbs |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to resolution of fever (the period from start of study-drug to relief of fever)
Measured: one year
Secondary outcomes (2)
time to resolution of respiratory symptoms(defined as the period from start of study-drug to relief of symptoms)
Measured: one year
virus shedding time
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Investigators
- Chen Wang, Doctor, Study chair, Capital Medical University affiliated Beijing Chaoyang Hospital, Beijing Respiratory Medicine InsitituteQingquan Liu, Docter, Principal investigator, Beijing Chinese Traditional Medicine University affiliated Dongzhimen HospitalYu Mao, Doctor, Principal investigator, Beijing Ditan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00935194
- Sponsor's protocol ID
- Z09000700090903
- Status last verified
- Nov 2009
- First submitted
- 7 Jul 2009
- Last updated
- 1 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 21844547
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 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 Infection: Multi-centre, Prospective, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT00935194
- Acronym / sponsor ID
- Z09000700090903
- Conditions
- Influenza
- Keywords
- Novel Influenza A(H1N1), Oseltamivir, Chinese Medicinal Herbs
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 8 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| blank | Experimental | Other: blankdo not take antiviral therapy |
| Oseltamivir | Experimental | Drug: oseltamivirantiviral therapy |
| chinese medicinary herbs | Experimental | Drug: chinese medicinal herbsantiviral therapy |
| oseltalmivir and chinese medicinal herbs | Experimental | Drug: oseltamivir and chinese medicinal herbscombination antiviral therapy |
Who may qualify
- Ages
- 14 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
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: TamifluTM75mg,bid,for 5 days | Drug | Oseltamivir |
| blankno antiviral therapy | Other | blank |
| chinese medicinal herbs200ml,p.o,qid,for 5 days | Drug | chinese medicinary herbs |
| oseltamivir and chinese medicinal herbsoseltamivir:75mg,p.o,bid,for 5 days; chinese medicinal herbs:200ml,p.o,qid,for 5 days | Drug | oseltalmivir and chinese medicinal herbs |
Primary outcome
time to resolution of fever (the period from start of study-drug to relief of fever)
Time frame: one year
2 secondary outcomes
time to resolution of respiratory symptoms(defined as the period from start of study-drug to relief of symptoms)
Time frame: one year
virus shedding time
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2009.
- Derived from this study: PubMed 21844547Wang 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.
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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
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
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, blank 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 3 inclusion and 11 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: finished, as of the sponsor's last update on 1 Dec 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to resolution of fever (the period from start of study-drug to relief of fever) (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00935194, which also lists 1 linked publication.
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 1 Dec 2009.