Clinical trial NCT03091218: Surveillance for Early Liver Injuries Caused by Runzao Zhiyang Capsule.
Official title: A Registry Study to Surveil Early Liver Injuries Caused by Runzao Zhiyang Capsule (RZZY Capsule).
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Drug-Induced Liver Injury
Keywords: Drug-Induced Liver Injury
Lead sponsor: Beijing 302 Hospital
Sponsor class: OTHER
First posted: 2017-03-27
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: community sample and primary care clinic

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.

Eligibility criteria: 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）.

Primary outcomes:
measure: The detection of patients with serum liver biochemistry abnormalities within 8 weeks after intake of RZZY Capsule.
timeFrame: participants will be followed duration intake of RZZY Capsule, an expected average within 8 weeks
Secondary outcomes:
measure: Clinical features of early liver injuries caused by RZZY Capsule assessed by serum parameters of liver function.
timeFrame: participants will be followed duration intake of RZZY Capsule, an expected average of 8 weeks
Other outcomes:
measure: Disease progression of early liver injuries caused by RZZY Capsule, i.e. death, liver failure, chronic DILI, recovery.
timeFrame: 8 weeks
Locations:
city: Beijing Shi
country: China
facility: 302 Military Hospital
state: Beijing
Study officials:
affiliation: 302 Military Hospital
name: Xiao-he Xiao
role: STUDY_DIRECTOR
References: