NCT03091218

Surveillance for Early Liver Injuries Caused by Runzao Zhiyang Capsule.

A Registry Study to Surveil Early Liver Injuries Caused by Runzao Zhiyang Capsule (RZZY Capsule).

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Beijing 302 Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This is a prospective registry study to surveil early liver injuries caused by Runzao Zhiyang Capsule (RZZY Capsule) through a non-intervention observational way. And attempt to establish a predictive model to screen susceptibilities to RZZY Capsule.

Detailed description

The primary objectives of this study include: (i) The detection of patients with serum liver biochemistry abnormalities less than 8 weeks after intake of RZZY Capsule; (ii) The record of overall individuals with demographics, underlying diseases, physical status, medication information, clinical laboratory index, and so on; (iii) The specimen collection of surveiled individuals. (iv) The attempt to establish a predictive model to screen susceptibilities to RZZY Capsule.

Conditions

• Drug-Induced Liver Injury

Timeline

• Start date: 2017-03-25
• Primary completion: 2017-12-31
• Completion: 2017-12-31
• First posted: 2017-03-27
• Last updated: 2017-03-27

Locations

1 site across 1 country: China