Clinical Trial: Surveillance for Early Liver Injuries Caused by Xianlin Gubao Capsule.

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational [Patient Registry]

Official Title: A Registry Study to Surveil Early Liver Injuries Caused by Xianlin Gubao Capsule (XLGB Capsule)

Brief Summary: This is a prospective registry study to surveil early liver injuries caused by Xianlin Gubao Capsule (XLGB Capsule) through a non-intervention observational way. And attempt to establish a predictive model to screen susceptibilities to XLGB Capsule.

Detailed Summary:

The primary objectives of this study include:

(i) The detection of patients with serum liver biochemistry abnormalities within 8 weeks after intake of XLGB 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 XLGB Capsule.

Sponsor: Beijing 302 Hospital

Current Primary Outcome: The detection of patients with serum liver biochemistry abnormalities within 8 weeks after intake of XLGB Capsule. [ Time Frame: participants will be followed duration intake of XLGB Capsule, an expected average within 8 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Clinical features of early liver injuries caused by XLGB Capsule assessed by serum parameters of liver function. [ Time Frame: participants will be followed duration intake of XLGB Capsule, an expected average of 8 weeks ]

Original Secondary Outcome: Same as current

Information By: Beijing 302 Hospital

Dates:
Date Received: March 10, 2017
Date Started: March 25, 2017
Date Completion: December 31, 2017
Last Updated: March 21, 2017
Last Verified: March 2017