Ischemic StrokeRSCMI-INCT01508403
A Registry Study on Shuxuetong (a Chinese Medicine Injection) Used in Twenty Hospitals
An observational study of Ischemic Stroke, run by China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
The purpose of this study is to make a cohort event monitoring to see whether and how Shuxuetong injection in hospital results in adverse events or adverse drug reactions. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ischemic Stroke
- Type of treatment
- Injection or infusion
- How many people
- 30,000 participants
- Where
- 1 siteChina
- Study dates
- Jan 2012to Dec 2015
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: all inpatients used or will use Shuxuetong injection in 20 selected hospitals in mainland China
Who may be able to join
- all inpatients use Shuxuetong injection in 20 selected hospitals during their hospital stay
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100700
About this study
The purpose of this study is to make a cohort event monitoring to see whether and how Shuxuetong injection in hospital results in adverse events or adverse drug reactions.
Read the detailed description
This is the first academic registry study about adverse events or adverse drug reaction for Chinese medicine injection in mainland China.
It is well known that Chinese medicine injection is just limited in mainland China, which also be accepted by China health care system.
However, more and more adverse events or adverse drug reaction have been reported in recent years in the form of case report.
In order to improving monitoring adverse events or adverse drug reaction of Chinese medicine injection in hospital, registry study will be introduced in this area.
To calculate the incidence of adverse events or adverse drug reaction is one of the main aims for this study.
According to the 'rule of three', 30,000 cases need to be registered at least.
- Conditions
- Ischemic Stroke
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Shuxuetong injection | a cohort using Shuxuetong injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events; incidence of Shuxuetong'ADRs and identify factors that contributed to the occurrence of the adverse reaction
All participants will be followed for the duration of hospital stay, an expected average of 2 weeks.Patients using Shuxuetong will be registered on a registration form including disease background, Shuxuetong's administration, and extraction information from hospital information system. An adverse event or drug adverse reaction form also will be used to describe any doubted symptoms or signs from patients. A judgment will be made by doctors directly and a further analysis will be conducted by researchers to decide those potential side effects of Shuxuetong.
Measured: to assess Shuxuetong's "adverse event" and "drug adverse reaction" during patients' hospital stay, administration information of Shuxuetong will be registered every day. The registry procedure will last 3 years only for patients using Shuxuetong.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2014 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 30,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Xiyuan Hospital of China Academy of Chinese Medical Sciences
- Responsible party
- Principal investigator, Yanming Xie, China Academy of Chinese Medical Sciences
- Investigators
- Yan M Xie, Principal investigator, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01508403
- Sponsor's protocol ID
- 2009zx09502-030
- Acronym
- RSCMI-I
- Status last verified
- May 2013
- First submitted
- 20 Dec 2011
- Last updated
- 14 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Registry Study on Shuxuetong (a Chinese Medicine Injection) Used in Twenty Hospitals
- ClinicalTrials.gov ID
- NCT01508403
- Acronym / sponsor ID
- RSCMI-I / 2009zx09502-030
- Conditions
- Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- Xiyuan Hospital of China Academy of Chinese Medical Sciences
- Study start
- Jan 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 12 Jan 2012 (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 make a cohort event monitoring to see whether and how Shuxuetong injection in hospital results in adverse events or adverse drug reactions.
Detailed description
This is the first academic registry study about adverse events or adverse drug reaction for Chinese medicine injection in mainland China.
It is well known that Chinese medicine injection is just limited in mainland China, which also be accepted by China health care system.
However, more and more adverse events or adverse drug reaction have been reported in recent years in the form of case report.
In order to improving monitoring adverse events or adverse drug reaction of Chinese medicine injection in hospital, registry study will be introduced in this area.
To calculate the incidence of adverse events or adverse drug reaction is one of the main aims for this study.
According to the 'rule of three', 30,000 cases need to be registered at least.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shuxuetong injection | – | –a cohort using Shuxuetong injection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all inpatients used or will use Shuxuetong injection in 20 selected hospitals in mainland China
Key inclusion criteria (1 listed)
- all inpatients use Shuxuetong injection in 20 selected hospitals during their hospital stay
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with adverse events; incidence of Shuxuetong'ADRs and identify factors that contributed to the occurrence of the adverse reaction
Time frame: to assess Shuxuetong's "adverse event" and "drug adverse reaction" during patients' hospital stay, administration information of Shuxuetong will be registered every day. The registry procedure will last 3 years only for patients using Shuxuetong.
All participants will be followed for the duration of hospital stay, an expected average of 2 weeks.Patients using Shuxuetong will be registered on a registration form including disease background, Shuxuetong's administration, and extraction information from hospital information system. An adverse event or drug adverse reaction form also will be used to describe any doubted symptoms or signs from patients. A judgment will be made by doctors directly and a further analysis will be conducted by researchers to decide those potential side effects of Shuxuetong.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2013.
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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.
Yan M Xie principal investigator
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by China Academy of Chinese Medical Sciences 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 1 inclusion and 0 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 14 May 2013. 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?
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?
Number of participants with adverse events; incidence of Shuxuetong'ADRs and identify factors that contributed to the occurrence of the adverse reaction (time frame: to assess Shuxuetong's "adverse event" and "drug adverse reaction" during patients' hospital stay, administration information of Shuxuetong will be registered every day. The registry procedure will last 3 years only for patients using Shuxuetong.). 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 14 May 2013.