NCT03192748

A Registry Study of Runzaozhiyang Capsule Used in Clinical Real World

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 3,000 (estimated)
• Sponsor: China Academy of Chinese Medical Sciences · Academic / Other
• Sex: All
• Age: 1 Hour
• Healthy volunteers: Not accepted

Summary

The purpose of this study is get to know what and how Runzaozhiyang 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 clinical real world, 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 Runzaozhiyang capsule 's with abnormal liver function before medication from June 2017 to June 2019.

Conditions

• Eczema

Timeline

• Start date: 2017-06-19
• Primary completion: 2017-06-19
• Completion: 2019-06-30
• First posted: 2017-06-20
• Last updated: 2017-06-20