Surveillance for Early Liver Injuries Caused by Runzao Zhiyang Capsule.

A Registry Study to Surveil Early Liver Injuries Caused by Runzao Zhiyang Capsule (RZZY Capsule).

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03091218

Enrollment

1000

Registered

2017-03-27

Start date

2017-03-25

Completion date

2017-12-31

Last updated

2017-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug-Induced Liver Injury

Keywords

Drug-Induced Liver Injury

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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）.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Other

Measure	Time frame	Description
Disease progression of early liver injuries caused by RZZY Capsule, i.e. death, liver failure, chronic DILI, recovery.	8 weeks	Disease progression of early liver injuries caused by RZZY Capsule, i.e. death, liver failure, chronic DILI, recovery.

Countries

China

Contacts

Primary ContactXiao-he Xiao

pharmacy302xxh@126.com+86 66933322

Backup ContactJia-bo Wang

pharm_sci@126.com+86 66933323

Outcome results