Surveillance for Early Liver Injuries Caused by Zhuanggu Guanjie Pill

A Registry Study to Surveil Early Liver Injuries Caused by Zhuanggu Guanjie Pill (ZGGJ Pill)

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03060252

Enrollment

1000

Registered

2017-02-23

Start date

2017-03-25

Completion date

2017-12-31

Last updated

2017-03-28

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 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.

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 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）.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Other

Measure	Time frame	Description
Disease progression of HILI caused by ZGGJ Pill, i.e. death, liver failure, chronic DILI, recovery.	8 weeks	Disease progression of HILI caused by ZGGJ Pill, 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