Study on Registration of Xinyuan Capsule

Status Not yet recruiting

Clinical 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03197844
Study type	Observational
Source	China Academy of Chinese Medical Sciences
Contact	Yanming Xie, BA
Phone	86-13911112416
Email	datamining5288@163.com
Status	Not yet recruiting
Phase	N/A
Start date	June 23, 2017
Completion date	December 31, 2018

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