Study on Registration of Xinyuan Capsule

China Academy of Chinese Medical Sciences

Status

Unknown

Conditions

Coronary Disease

Study type

Observational

Funder types

Other

Identifiers

NCT03197844

xinyuan

Details and patient eligibility

About

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.

Full 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.

Enrollment

3,000 estimated patients

Sex

All

Ages

1+ hour old

Volunteers

No Healthy Volunteers

Inclusion criteria