Influenza A Virus, H1N1 Subtype200907001-2ANCT01053533
A Pragmatic Randomized Controlled Trial of Chinese Herbal Medicine for Severe Pandemic H1N1 Influenza
A study testing Chinese herbal medicines plus western therapy and western therapy in people with Influenza A Virus, H1N1 Subtype, run by Beijing Ditan Hospital at 1 site in China.
Trial summary
The aim of this study is to evaluate the effectiveness and safety of Chinese herbal medicines for severe pandemic H1N1 influenza. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Influenza A Virus, H1N1 Subtype
- What is being tested?
- Chinese herbal medicines plus western therapy and western therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,100 participants
- Where
- 1 siteChina
- Study dates
- Jan 2010to Apr 2010
- Phase
- Interventional
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of severe pandemic H1N1 influenza patients and pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza
- Rapid Diagnostic Tests:positive
- Age≥6 years
- Influenza symptoms occurred less than 48 hours and body temperature≥37.5℃ for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza
Who cannot join
- Suffering from mental illness
- Attending other clinical studies on influenza
- Critical pandemic H1N1 influenza patients
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Mao Yu
Beijing, Beijing Municipality, 100015
Yu Mao, myqmz58@yahoo.com
Guang Yu Wang, influenzatcm@163.com
About this study
The aim of this study is to evaluate the effectiveness and safety of Chinese herbal medicines for severe pandemic H1N1 influenza.
- Conditions
- Influenza A Virus, H1N1 Subtype
- Being tested
- Chinese herbal medicines plus western therapy, western therapy
- Keywords
- Chinese herbal medicines, pandemic H1N1 influenza, effectiveness, safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese herbal medicines plus western therapyDrug
injections of Chinese herbal medicines and Chinese herbal medicines decoction\& supportive therapy and antivirus therapy when necessary
western therapyDrug
supportive therapy and antivirus therapy when necessary
| Study group | Role | What they receive |
|---|---|---|
| Chinese herbal medicines plus western therapy | Experimental | Not described Receives: Drug: Chinese herbal medicines plus western therapy |
| western therapy | Active comparator | including supportive therapy and antivirus therapy when necessary Receives: Drug: western therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of complication
Measured: 10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients.
mortality of pandemic H1N1 influenza and all-cause mortality(only for severe pandemic H1N1 influenza patients)
Measured: 28 days
proportion of deteriorating into severe H1N1 influenza (only for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza)
Measured: 10 days
Secondary outcomes (8)
time to allaying a fever
Measured: 10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients
time to symptom relief
Measured: 10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients
time and proportion of H1N1 virus turning to negative
Measured: 10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients
direct medical cost
Measured: 10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients
safety outcome(adverse effects)
Measured: 10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients
days in hospital
Measured: 10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients
dose and usage of hormones(only for severe pandemic H1N1 influenza patients)
Measured: 28 days
Inflammation of lung tissue(only for severe pandemic H1N1 influenza patients)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionApr 2010 (estimated)
- Study completionApr 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza A Virus, H1N1 SubtypeStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Ditan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing University of Chinese Medicine, State Administration of Traditional Chinese Medicine of the People's Republic of China, China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01053533
- Sponsor's protocol ID
- 20100118
- Acronym
- 200907001-2A
- Status last verified
- Jan 2010
- First submitted
- 19 Jan 2010
- Last updated
- 8 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Randomized Controlled Trial of Chinese Herbal Medicine for Severe Pandemic H1N1 Influenza
- ClinicalTrials.gov ID
- NCT01053533
- Acronym / sponsor ID
- 200907001-2A / 20100118
- Conditions
- Influenza A Virus, H1N1 Subtype
- Keywords
- Chinese herbal medicines, pandemic H1N1 influenza, effectiveness, safety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- Beijing Ditan HospitalUniversity, hospital or other
- Collaborators
- Beijing University of Chinese Medicine, State Administration of Traditional Chinese Medicine of the People's Republic of China, China Academy of Chinese Medical Sciences
- Study start
- Jan 2010
- Primary completion
- Apr 2010 (estimated)
- Study completion
- Apr 2010 (estimated)
- First posted
- 21 Jan 2010 (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 aim of this study is to evaluate the effectiveness and safety of Chinese herbal medicines for severe pandemic H1N1 influenza.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chinese herbal medicines plus western therapy | Experimental | Drug: Chinese herbal medicines plus western therapy |
| western therapy | Active comparator | Drug: western therapyincluding supportive therapy and antivirus therapy when necessary |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of severe pandemic H1N1 influenza patients and pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza
- Rapid Diagnostic Tests:positive
- Age≥6 years
- Influenza symptoms occurred less than 48 hours and body temperature≥37.5℃ for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza
Key exclusion criteria (3 listed)
- Suffering from mental illness
- Attending other clinical studies on influenza
- Critical pandemic H1N1 influenza patients
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 |
|---|---|---|
| Chinese herbal medicines plus western therapyinjections of Chinese herbal medicines and Chinese herbal medicines decoction\& supportive therapy and antivirus therapy when necessary | Drug | Chinese herbal medicines plus western therapy |
| western therapysupportive therapy and antivirus therapy when necessary | Drug | western therapy |
Primary outcome
incidence of complication
Time frame: 10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients.
mortality of pandemic H1N1 influenza and all-cause mortality(only for severe pandemic H1N1 influenza patients)
Time frame: 28 days
proportion of deteriorating into severe H1N1 influenza (only for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza)
Time frame: 10 days
8 secondary outcomes
time to allaying a fever
Time frame: 10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients
time to symptom relief
Time frame: 10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients
time and proportion of H1N1 virus turning to negative
Time frame: 10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients
direct medical cost
Time frame: 10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients
safety outcome(adverse effects)
Time frame: 10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients
days in hospital
Time frame: 10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients
dose and usage of hormones(only for severe pandemic H1N1 influenza patients)
Time frame: 28 days
Inflammation of lung tissue(only for severe pandemic H1N1 influenza patients)
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2010.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chinese herbal medicines plus western therapy and western therapy in people with Influenza A Virus, H1N1 Subtype, run by Beijing Ditan Hospital 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 3 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 8 Jun 2010. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of complication (time frame: 10 days for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza;28 days for severe pandemic H1N1 influenza patients.). The study lists 3 primary outcomes in all. 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 8 Jun 2010.