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)

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.

Study Overview

• Status: Unknown
• Conditions: Drug-Induced Liver Injury

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.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing Shi, Beijing, China, 100039
      • 302 Military Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

community sample and primary care clinic

Description

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）.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
The overall individuals taking ZGGJ Pill; The overall individuals taking ZGGJ Pill with recommended dosage and achieving the inclusion criteria.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The detection of patients with serum liver biochemistry abnormalities less than 8 weeks after intake of ZGGJ Pill.	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical features of early liver injuries caused by ZGGJ Pill assessed by serum parameters of liver function.	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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Beijing 302 Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): March 25, 2017
• Primary Completion (Anticipated): December 31, 2017
• Study Completion (Anticipated): December 31, 2017

Study Registration Dates

• First Submitted: February 15, 2017
• First Submitted That Met QC Criteria: February 17, 2017
• First Posted (Actual): February 23, 2017

Study Record Updates

• Last Update Posted (Actual): March 28, 2017
• Last Update Submitted That Met QC Criteria: March 25, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Drug-Induced Liver Injury
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Digestive System Diseases; Liver Diseases; Drug-Related Side Effects and Adverse Reactions; Poisoning; Wounds and Injuries; Chemical and Drug Induced Liver Injury
• Other Study ID Numbers: 302-xxh-ZGGJP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided