Clinical Trial: Surveillance for Early Liver Injuries Caused by Zhuanggu Guanjie Pill

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 Zhuanggu Guanjie Pill (ZGGJ Pill)

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

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 ZGGJ Pill; (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 ZGGJ Pill.


Sponsor: Beijing 302 Hospital

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

The detection of patients with serum liver biochemistry abnormalities less than 8 weeks after intake of ZGGJ Pill.


Original Primary Outcome: The detection of patients with serum liver biochemistry abnormalities less than 8 weeks after intake of ZGGJ Pill. [ Time Frame: participants will be followed duration intake of ZGGJ Pill, an expected average within 8 weeks ]

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

Clinical features of early liver injuries caused by ZGGJ Pill assessed by serum parameters of liver function.


Original Secondary Outcome: Clinical features of early liver injuries caused by ZGGJ Pill assessed by serum parameters of liver function. [ Time Frame: Participants will be followed duration intake of ZGGJ Pill, an expected average of 8 weeks ]

Information By: Beijing 302 Hospital

Dates:
Date Received: February 15, 2017
Date Started: March 25, 2017
Date Completion: December 31, 2017
Last Updated: March 25, 2017
Last Verified: March 2017