Surveillance for Early Liver Injuries Caused by Xianlin Gubao Pill.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-25

Study Completion Date

2017-12-31

Brief Summary

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This is a prospective registry study to surveil early liver injuries caused by Xianlin Gubao Pill (XLGB Pill) through a non-intervention observational way. And attempt to establish a predictive model to screen susceptibilities to XLGB Pill.

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Detailed Description

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The primary objectives of this study include:

(i) The detection of patients with serum liver biochemistry abnormalities within 8 weeks after intake of XLGB 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 XLGB Pill.

Conditions

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Drug-Induced Liver Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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The individuals taking XLGB Pill

The overall individuals taking XLGB Pill with recommended dosage and achieving the inclusion criteria.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Individuals in accordance with indications for XLGB Pill, including symptoms of osteoporosis;
2. The age range of 18 to 70 years；
3. Individuals taking XLGB Pill 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 XLGB Pill;
2. Unconformity to the XLGB Pill drug label;
3. Individual taking XLGB Pill less than 2 weeks;
4. Individuals taking other hepatotoxic drugs combined with XLGB Pill, simultaneously;
5. Unconformity to the diagnostic standard for herb-induced liver injury (the Guideline for Diagnosis and Treatment of Herb-induced Liver Injury, RPGIP-2016CN003）.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes