Surveillance for Early Liver Injuries Caused by Yangxue Shengfa Capsule.

• Conditions: Drug-Induced Liver Injury

• Registration Number: NCT03113838
• Lead Sponsor: Beijing 302 Hospital

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 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 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.

Study Timeline

• Study First Submitted: 2017-02-17
• Status Verified: 2017-04
• Study First Submitted QC: 2017-04-10
• Last Update Submitted: 2017-04-10
• Study First Posted: 2017-04-14
• Last Update Posted: 2017-04-14
• Study Start: 2017-04-17
• 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 YXSF Capsule, including xerasia, itchy scalp, alopecia areata, seborrheic dermatitis and alopecia;

2. The age range of 18 to 70 years；

3. Individuals taking YXSF Capsule over 2 weeks;

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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