Coronary DiseaseNCT03197844
Study on Registration of Xinyuan Capsule
An observational study of Coronary Disease, run by China Academy of Chinese Medical Sciences.
Trial summary
The purpose of this study is get to know what and how Xinyuan capsule in hospital results in drug-induced liver injury or adverse drug reactions from a cohort event monitoring as registration research. Read more about this study
- Who is it for?
- Ages 1 hour and older
- Conditions the study is for
- Coronary Disease
- How many people
- 3,000 participants
- Where
- No sites listed yet
- Study dates
- 23 Jun 2017to 31 Dec 2018
- 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 1 hour and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The aim population for observation is who using Xinyuan capsule 's with abnormal liver function before medication from June 2017 to December 2018.
Who may be able to join
- Patients using Xinyuan capsule 's with abnormal liver function before medication from June 2017 to December 2018.
Who cannot join
- None.
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of this study is get to know what and how Xinyuan capsule in hospital results in drug-induced liver injury or adverse drug reactions from a cohort event monitoring as registration research.
Read the detailed description
In order to improving monitoring drug-induced liver injury or adverse drug reactions of Chinese medicine containing Radix Polygoni Multiflori in hospital, registry study is suitable method in this area. Otherwise, nested case control study is used to find out the mechanism of drug-induced liver injury. Calculate the incidence of drug-induced liver injury or adverse drug reactions is one of the main aims for this study. Safety surveillance on Chinese medicine containing Radix Polygoni Multiflori is an important problem that needs to be sorted out through large sample observational study. According to the relevant regulations of the CFDA, 3000 cases need to be registered at least. The aim population is who using Xinyuan capsule 's with abnormal liver function before medication from June 2017 to December 2018.
- Conditions
- Coronary Disease
- Medical subject headings
- Coronary Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Is there any abnormality in liver function test index（ALT、AST、TBil、GGT）after using xinyuan capsule around four weeks later?
Based on data from the National Center for adverse drug reactions (ADR), Chinese herbal medicine containing Polygonum multiflorum may cause liver damage, but further confirmation is needed.The liver function includes glutamic-pyruvic transaminase,glutamic-oxalacetic transaminase,GGT,TBil.
Measured: After using xinyuan capsule around four weeks later.
Secondary outcomes (3)
Is there any abnormality in renal function test index（Bun、Cr） after using xinyuan capsule around four weeks later?
Observation of whether the kidney function damage after treatment.The renal function includes creatinine,usea nitrogen.
Measured: After using xinyuan capsule around four weeks later.
Is there any abnormality in ECG after using xinyuan capsule around four weeks later?
Observation of whether the ECG damage after treatment.ECG is the most common method of detection of myocardial ischemia and the diagnosis of angina pectoris.
Measured: After using xinyuan capsule around four weeks later.
Is there any abnormality in basic life sign（body temperature, blood pressure and pulse）during using xinyuan capsule around four weeks？
Observation of whether the basic life sign damage after treatment.In the medical care system, body temperature, blood pressure and pulse are the most important and basic three physiological parameters of the vital signs.
Measured: During using xinyuan capsule around four weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study start23 Jun 2017 (estimated)
- Primary completion23 Jun 2017 (estimated)
- Study completion31 Dec 2018 (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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 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
- Yanming Xie, BA, Principal investigator, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03197844
- Sponsor's protocol ID
- xinyuan
- Status last verified
- Jun 2017
- First submitted
- 14 Jun 2017
- Last updated
- 23 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Registration of Xinyuan Capsule
- ClinicalTrials.gov ID
- NCT03197844
- Acronym / sponsor ID
- xinyuan
- Conditions
- Coronary Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 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
- 23 Jun 2017 (estimated)
- Primary completion
- 23 Jun 2017 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 23 Jun 2017 (actual)
- 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 Xinyuan capsule in hospital results in drug-induced liver injury or adverse drug reactions from a cohort event monitoring as registration research.
Detailed description
In order to improving monitoring drug-induced liver injury or adverse drug reactions of Chinese medicine containing Radix Polygoni Multiflori in hospital, registry study is suitable method in this area. Otherwise, nested case control study is used to find out the mechanism of drug-induced liver injury. Calculate the incidence of drug-induced liver injury or adverse drug reactions is one of the main aims for this study. Safety surveillance on Chinese medicine containing Radix Polygoni Multiflori is an important problem that needs to be sorted out through large sample observational study. According to the relevant regulations of the CFDA, 3000 cases need to be registered at least. The aim population is who using Xinyuan capsule 's with abnormal liver function before medication from June 2017 to December 2018.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 hour and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The aim population for observation is who using Xinyuan capsule 's with abnormal liver function before medication from June 2017 to December 2018.
Key inclusion criteria (1 listed)
- Patients using Xinyuan capsule 's with abnormal liver function before medication from June 2017 to December 2018.
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
Is there any abnormality in liver function test index（ALT、AST、TBil、GGT）after using xinyuan capsule around four weeks later?
Time frame: After using xinyuan capsule around four weeks later.
Based on data from the National Center for adverse drug reactions (ADR), Chinese herbal medicine containing Polygonum multiflorum may cause liver damage, but further confirmation is needed.The liver function includes glutamic-pyruvic transaminase,glutamic-oxalacetic transaminase,GGT,TBil.
3 secondary outcomes
Is there any abnormality in renal function test index（Bun、Cr） after using xinyuan capsule around four weeks later?
Time frame: After using xinyuan capsule around four weeks later.
Is there any abnormality in ECG after using xinyuan capsule around four weeks later?
Time frame: After using xinyuan capsule around four weeks later.
Is there any abnormality in basic life sign（body temperature, blood pressure and pulse）during using xinyuan capsule around four weeks？
Time frame: During using xinyuan capsule around four weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2017.
- Individual participant dataSharing planned: No
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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.
Yanming 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, 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 23 Jun 2017. 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?
Contact Yanming Xie, BA (86-13911112416, datamining5288@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Is there any abnormality in liver function test index（ALT、AST、TBil、GGT）after using xinyuan capsule around four weeks later? (time frame: After using xinyuan capsule around four weeks later.). 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 23 Jun 2017.