Surveillance for Early Liver Injuries Caused by Zhuanggu Guanjie Pill

• Conditions: Drug-Induced Liver Injury

• Registration Number: NCT03060252
• Lead Sponsor: Beijing 302 Hospital

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 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 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.

Study Timeline

• Study First Submitted: 2017-02-15
• Study First Submitted QC: 2017-02-17
• Study First Posted: 2017-02-23
• Status Verified: 2017-03
• Study Start: 2017-03-25
• Last Update Submitted: 2017-03-25
• Last Update Posted: 2017-03-28
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

1. Individuals in accordance with indications for ZGGJ Pill, including osteoarthritis, and lumbar muscle strain;

2. The age range of 18 to 70 years；

3. Individuals taking ZGGJ Pill over 2 weeks;

4. Abnormalities of serum biochemistry achieving one of the criteria as follows:

   (i) alanine aminotransaminase (ALT) or aspartate transaminase (AST) ≥2 folds of upper limit of normal (ULN); (ii) total bilirubin (TBiL) ≥ 2 ULN; (iii) alkaline phosphatase (ALP) ≥ 2 ULN;

5. Individuals can provide informed consent form.

Exclusion Criteria

1. Individuals without indications for ZGGJ Pill;
2. Inconformity with the ZGGJ Pill drug label;
3. Individual taking ZGGJ Pill within 2 weeks;
4. Individuals taking other hepatotoxic drugs combined with ZGGJ Pill, simultaneously;
5. Inconformity with the diagnostic criteria for herb-induced liver injury (the Guideline for Diagnosis and Treatment of Herb-induced Liver Injury, RPGIP-2016CN003）.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

302 Military Hospital; 🇨🇳 Beijing Shi, Beijing, China