Surveillance for Early Liver Injuries Caused by Runzao Zhiyang Capsule.

NCT03091218 | Unknown DMC

• 1 other identifier: 302-xxh-RZZYC
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug-Induced Liver Injury

Keywords

Drug-Induced Liver Injury

Outcome Measures

Primary Outcomes (1)

• The detection of patients with serum liver biochemistry abnormalities within 8 weeks after intake of RZZY Capsule.

  The detection of patients with serum liver biochemistry abnormalities within 8 weeks after intake of RZZY Capsule.

  participants will be followed duration intake of RZZY Capsule, an expected average within 8 weeks

Secondary Outcomes (1)

• 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

Other Outcomes (1)

• Disease progression of early liver injuries caused by RZZY Capsule, i.e. death, liver failure, chronic DILI, recovery.

  8 weeks

Study Arms (1)

The individuals taking RZZY Capsule

The overall individuals taking RZZY Capsule with recommended dosage and achieving the inclusion criteria.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

community sample and primary care clinic

You may qualify if:

• 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.

You may not qualify if:

• 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）.

Sponsors & Collaborators

• Beijing 302 Hospital: lead

Study Sites (1)

302 Military Hospital

Beijing, Beijing Municipality, 100039, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

serum, plasma, histology and urine.

MeSH Terms

Conditions

Chemical and Drug Induced Liver Injury

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Poisoning

Study Officials

• Xiao-he Xiao

  302 Military Hospital

  STUDY DIRECTOR

Central Study Contacts

Xiao-he Xiao

CONTACT

+86 66933322; pharmacy302xxh@126.com

Jia-bo Wang

CONTACT

+86 66933323; pharm_sci@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 8 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: March 10, 2017
• First Posted: March 27, 2017
• Study Start: March 25, 2017
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: March 27, 2017

Record last verified: 2017-03

Locations

CN (1)