NCT03598153

A Registry Study of Shujinjianyao Pill 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: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to get to know how Shujinjianyao Pill in hospital results in drug-induced liver injury or other adverse drug reactions from a cohort event monitoring as registration research.

Detailed description

In order to monitor drug-induced liver injury or other adverse drug reactions of Shujinjianyao Pill in clinical real world, registry study is a suitable method in this area. Meanwhile, the investigators will use nested case-control study to find out the mechanism of drug-induced liver injury. Calculate the incidence of drug-induced liver injury or other adverse drug reactions is one of the main aims for this study. Therefore, Safety monitoring of Shujinjianyao Pill is an very important problem that needs to be done through a large sample observational study. According to the relevant regulations of the state drug administration(SDA), 3000 cases need to be registered at least. The aim population is who use Shujinjianyao Pill with normal liver function before medication from June 2018 to October 2019.

Conditions

• Sciatica

Interventions

Type	Name	Description
DRUG	Shujinjianyao Pill	According to the usage and dosage of the instructions, patients should use the medicine dialectically and rationally for 4 weeks.

Timeline

• Start date: 2018-07-25
• Primary completion: 2019-10-31
• Completion: 2019-12-31
• First posted: 2018-07-26
• Last updated: 2018-08-02