Clinical Trial: Surveillance for Early Liver Injuries Caused by Yangxue Shengfa 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 Yangxue Shengfa Capsule (YXSF Capsule).
Brief Summary: This is a prospective registry study to surveil early liver injuries caused by Yangxue Shengfa Capsule (YXSF Capsule) through a non-intervention observational way. And attempt to establish a predictive model to screen susceptibilities to YXSF Capsule.
Detailed Summary:
The primary objectives of this study include:
(i) The detection of patients with serum liver biochemistry abnormalities less than 8 weeks after intake of YXSF 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 YXSF Capsule.
Sponsor: Beijing 302 Hospital
Current Primary Outcome: Number of patients with serum liver biochemistry abnormalities less than 8 weeks after intake of YXSF Capsule. [ Time Frame: participants will be followed duration intake of YXSF Capsule, an expected average of 8 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Clinical features of early liver injuries caused by YXSF Capsule assessed by serum parameters of liver function. [ Time Frame: participants will be followed duration intake of YXSF Capsule, an expected average of 8 weeks ]
Original Secondary Outcome: Same as current
Information By: Beijing 302 Hospital
Dates:
Date Received: February 17, 2017
Date Started: April 17, 2017
Date Completion: December 31, 2017
Last Updated: April 10, 2017
Last Verified: April 2017
