A Registry Study to Surveil Early Liver Injuries Caused by Runzao Zhiyang Capsule (RZZY Capsule).
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 1,000
- Locations
- 1
- Primary Endpoint
- The detection of patients with serum liver biochemistry abnormalities within 8 weeks after intake of RZZY Capsule.
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Individuals in accordance with indications for RZZY Capsule, including skin pruritus, acne vulgaris and constipation;
- •The age range of 18 to 70 years；
- •Individuals taking RZZY Capsule over 2 weeks;
- •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;
- •Individuals can provide informed consent form.
Exclusion Criteria
- •Individuals without indications for RZZY Capsule;
- •Unconformity with the RZZY Capsule drug label;
- •Individual taking RZZY Capsule less than 2 weeks;
- •Individuals taking other hepatotoxic drugs combined with RZZY Capsule, simultaneously;
- •Unconformity with the diagnostic standard for herb-induced liver injury (the Guideline for Diagnosis and Treatment of Herb-induced Liver Injury, RPGIP-2016CN003）.
Outcomes
Primary Outcomes
The detection of patients with serum liver biochemistry abnormalities within 8 weeks after intake of RZZY Capsule.
Time Frame: 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 Outcomes
- 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)
Investigators
Xiaohe Xiao
Director
Beijing 302 Hospital