Surveillance for Early Liver Injuries Caused by Runzao Zhiyang Capsule.

• Conditions: Drug-Induced Liver Injury

• Registration Number: NCT03091218
• Lead Sponsor: Beijing 302 Hospital

Brief 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.

Study Timeline

• Status Verified: 2017-03
• Study First Submitted: 2017-03-10
• Study First Submitted QC: 2017-03-21
• Last Update Submitted: 2017-03-21
• Study Start: 2017-03-25
• Study First Posted: 2017-03-27
• Last Update Posted: 2017-03-27
• 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 RZZY Capsule, including skin pruritus, acne vulgaris and constipation;

2. The age range of 18 to 70 years；

3. Individuals taking RZZY Capsule 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 RZZY Capsule;
2. Unconformity with the RZZY Capsule drug label;
3. Individual taking RZZY Capsule less than 2 weeks;
4. Individuals taking other hepatotoxic drugs combined with RZZY Capsule, simultaneously;
5. Unconformity with the diagnostic standard 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 within 8 weeks after intake of RZZY Capsule.	participants will be followed duration intake of RZZY Capsule, an expected average within 8 weeks	The detection of patients with serum liver biochemistry abnormalities within 8 weeks after intake of RZZY Capsule.

Secondary Outcome Measures

Name	Time	Method
Clinical features of early liver injuries caused by RZZY Capsule assessed by serum parameters of liver function.	participants will be followed duration intake of RZZY Capsule, an expected average of 8 weeks	Clinical features of early liver injuries caused by RZZY Capsule assessed by serum parameters of liver function.

Trial Locations

Locations (1)

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