Surveillance for Early Liver Injuries Caused by Yangxue Shengfa Capsule.

Drug-Induced Liver Injury Clinical Trial

Official title:

A Registry Study to Surveil Early Liver Injuries Caused by Yangxue Shengfa Capsule (YXSF Capsule).

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03113838
• Other study ID #: 302-xxh-YXSFC
• Status: Not yet recruiting
• Phase: N/A
• First received: February 17, 2017
• Last updated: April 10, 2017
• Start date: April 17, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: April 2017
• Source: Beijing 302 Hospital
• Contact: Xiao-he Xiao
• Phone: +86 66933322
• Email: pharmacy302xxh[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Drug-Induced Liver Injury
• Wounds and Injuries

Locations

Country	Name	City	State
China	302 Military Hospital	Beijing Shi	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing 302 Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Disease progression of early liver injuries caused by YXSF Capsule, i.e. death, liver failure, chronic DILI, recovery.	Disease progression of early liver injuries caused by YXSF Capsule, i.e. death, liver failure, chronic DILI, recovery.	8 weeks
Primary	Number of patients with serum liver biochemistry abnormalities less than 8 weeks after intake of YXSF Capsule.	The detection 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
Secondary	Clinical features of early liver injuries caused by YXSF Capsule assessed by serum parameters of liver function.	Clinical features of early liver injuries caused by YXSF Capsule assessed by serum parameters of liver function, such as liver biochemistry.	participants will be followed duration intake of YXSF Capsule, an expected average of 8 weeks