Coronary DiseaseRSCMI-VIINCT01752946
A Registry Study of Shuxuening Injection Used in Hospitals in China
An observational study of Coronary Disease and Intracranial Embolism, run by China Academy of Chinese Medical Sciences.
Trial summary
The purpose of this study is get to know what and how Shuxuening injection in hospital results in adverse events or adverse drug reactions from a cohort event monitoring. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Disease, Intracranial Embolism, Stroke
- How many people
- 30,000 participants
- Where
- No sites listed yet
- Study dates
- Oct 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: According to the 'rule of three', 30,000 cases need to be registered at least. The aim population is who using Shuxuening injection's during inpatient time from December 2012 to December.2014 in more than 30 hospitals in China.
Who may be able to join
- Patients using Shuxuening injection from 2012 to 2014
Who cannot join
- none
About this study
Official title: A Registry Study of Shuxuening (a Chinese Medicine Injection) Used in Hospitals in China
The purpose of this study is get to know what and how Shuxuening injection in hospital results in adverse events or adverse drug reactions from a cohort event monitoring.
Read the detailed description
Ginkgo leaf is major component of Shuxuening injection. Although some western countries product similar injections and use them, Shuxuening injection also regarded as Chinese medicine injection. As a TCM injection, the most important thing is how to safety use it in practice.
In order to improving monitoring adverse events or adverse drug reaction of Chinese medicine injection in hospital, registry study is suitable method in this area. Otherwise, nested case control study is used to find out the mechanism of allergic reaction.
Calculate the incidence of adverse events or adverse drug reaction is one of the main aims for this study. Safety surveillance on Chinese Medicine injection is an important problem that needs to be sorted out through large sample observational study.
According to the 'rule of three', 30,000 cases need to be registered at least. The aim population is who using Shuxuening injection's during inpatient time from December 2012 to December 2014.
Data will be collected for three departments as following:
Form A (green): demographic information ；Form B (pink): adverse drug events/reaction； Form C (white): extracted information from hospital information system and laboratory information system.
- Conditions
- Coronary Disease, Intracranial Embolism, Stroke, Angina Pectoris, Vasospasm
- Medical subject headings
- Coronary Disease, Intracranial Embolism, Stroke, Angina Pectoris
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Shuxuening injection's ADRs and factors 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 Shuxuening will be registered on a registration form including disease background, Shuxuening's administration, and extraction information from hospital information system. When the patients occurs allergic reaction during using Shuxuening injection, it also need to collect patient's biological samples. 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 Shuxuening injection.
Measured: to assess Shuxuening's "adverse event" and "drug adverse reaction" during patients' hospital stay, administration information of Shuxuening will be registered every day. The registry procedure will last 2 years only for patients using Shuxuening.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2015 (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 Coronary DiseaseStudies 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
- Beijing University of Chinese Medicine
- Responsible party
- Principal investigator, Xie Yanming, China Academy of Chinese Medical Sciences
- Investigators
- Yan M Xie, BA, Principal investigator, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01752946
- Sponsor's protocol ID
- 2009zx09502-030-07
- Acronym
- RSCMI-VII
- Status last verified
- Dec 2012
- First submitted
- 15 Dec 2012
- Last updated
- 20 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Registry Study of Shuxuening (a Chinese Medicine Injection) Used in Hospitals in China
- ClinicalTrials.gov ID
- NCT01752946
- Acronym / sponsor ID
- RSCMI-VII / 2009zx09502-030-07
- Conditions
- Coronary Disease, Intracranial Embolism, Stroke, Angina Pectoris, Vasospasm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- Beijing University of Chinese Medicine
- Study start
- Oct 2012
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 19 Dec 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 get to know what and how Shuxuening injection in hospital results in adverse events or adverse drug reactions from a cohort event monitoring.
Detailed description
Ginkgo leaf is major component of Shuxuening injection. Although some western countries product similar injections and use them, Shuxuening injection also regarded as Chinese medicine injection. As a TCM injection, the most important thing is how to safety use it in practice.
In order to improving monitoring adverse events or adverse drug reaction of Chinese medicine injection in hospital, registry study is suitable method in this area. Otherwise, nested case control study is used to find out the mechanism of allergic reaction.
Calculate the incidence of adverse events or adverse drug reaction is one of the main aims for this study. Safety surveillance on Chinese Medicine injection is an important problem that needs to be sorted out through large sample observational study.
According to the 'rule of three', 30,000 cases need to be registered at least. The aim population is who using Shuxuening injection's during inpatient time from December 2012 to December 2014.
Data will be collected for three departments as following:
Form A (green): demographic information ；Form B (pink): adverse drug events/reaction； Form C (white): extracted information from hospital information system and laboratory information system.
Study design
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- According to the 'rule of three', 30,000 cases need to be registered at least. The aim population is who using Shuxuening injection's during inpatient time from December 2012 to December.2014 in more than 30 hospitals in China.
Key inclusion criteria (1 listed)
- Patients using Shuxuening injection from 2012 to 2014
Key exclusion criteria (1 listed)
- none
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
Incidence of Shuxuening injection's ADRs and factors contributed to the occurrence of the adverse reaction
Time frame: to assess Shuxuening's "adverse event" and "drug adverse reaction" during patients' hospital stay, administration information of Shuxuening will be registered every day. The registry procedure will last 2 years only for patients using Shuxuening.
All participants will be followed for the duration of hospital stay, an expected average of 2 weeks. Patients using Shuxuening will be registered on a registration form including disease background, Shuxuening's administration, and extraction information from hospital information system. When the patients occurs allergic reaction during using Shuxuening injection, it also need to collect patient's biological samples. 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 Shuxuening injection.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2012.
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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, BA principal investigator
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Disease and Intracranial Embolism, run by China Academy of Chinese Medical Sciences.
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 1 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 20 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
Incidence of Shuxuening injection's ADRs and factors contributed to the occurrence of the adverse reaction (time frame: to assess Shuxuening's "adverse event" and "drug adverse reaction" during patients' hospital stay, administration information of Shuxuening will be registered every day. The registry procedure will last 2 years only for patients using Shuxuening.). 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 20 Dec 2012.