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Study on Registration of Xinyuan Capsule

NCT ID: NCT03197844

Last Updated: 2017-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-23

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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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

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Coronary Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients using Xinyuan capsule 's with abnormal liver function before medication from June 2017 to December 2018.

Exclusion Criteria

* None.
Minimum Eligible Age

1 Hour

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xiyuan Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role collaborator

China Academy of Chinese Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Yanming Xie

Deputy Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yanming Xie, BA

Role: PRINCIPAL_INVESTIGATOR

Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

Central Contacts

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Yanming Xie, BA

Role: CONTACT

[email protected]
86-13911112416

Lianxin Wang, doctor

Role: CONTACT

[email protected]
86-13521781839

Other Identifiers

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xinyuan

Identifier Type: -

Identifier Source: org_study_id

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