Study on Registration of Xinyuan Capsule

• Conditions: Coronary Disease

• Registration Number: NCT03197844
• Lead Sponsor: China Academy of Chinese Medical Sciences

Brief Summary

The purpose of this study is get to know what and how Xinyuan capsule in hospital results in drug-induced liver injury or adverse drug reactions from a cohort event monitoring as registration research.

Detailed Description

In order to improving monitoring drug-induced liver injury or adverse drug reactions of Chinese medicine containing Radix Polygoni Multiflori in hospital, registry study is suitable method in this area. Otherwise, nested case control study is used to find out the mechanism of drug-induced liver injury. Calculate the incidence of drug-induced liver injury or adverse drug reactions is one of the main aims for this study. Safety surveillance on Chinese medicine containing Radix Polygoni Multiflori is an important problem that needs to be sorted out through large sample observational study. According to the relevant regulations of the CFDA, 3000 cases need to be registered at least. The aim population is who using Xinyuan capsule 's with abnormal liver function before medication from June 2017 to December 2018.

Study Timeline

• Status Verified: 2017-06
• Study First Submitted: 2017-06-14
• Study First Submitted QC: 2017-06-21
• Last Update Submitted: 2017-06-21
• Study Start: 2017-06-23
• Primary Completion: 2017-06-23
• Study First Posted: 2017-06-23
• Last Update Posted: 2017-06-23
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• Patients using Xinyuan capsule 's with abnormal liver function before medication from June 2017 to December 2018.

Exclusion Criteria

• None.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Is there any abnormality in liver function test index（ALT、AST、TBil、GGT）after using xinyuan capsule around four weeks later?	After using xinyuan capsule around four weeks later.	Based on data from the National Center for adverse drug reactions (ADR), Chinese herbal medicine containing Polygonum multiflorum may cause liver damage, but further confirmation is needed.The liver function includes glutamic-pyruvic transaminase,glutamic-oxalacetic transaminase,GGT,TBil.

Secondary Outcome Measures

Name	Time	Method
Is there any abnormality in basic life sign（body temperature, blood pressure and pulse）during using xinyuan capsule around four weeks？	During using xinyuan capsule around four weeks.	Observation of whether the basic life sign damage after treatment.In the medical care system, body temperature, blood pressure and pulse are the most important and basic three physiological parameters of the vital signs.
Is there any abnormality in ECG after using xinyuan capsule around four weeks later?	After using xinyuan capsule around four weeks later.	Observation of whether the ECG damage after treatment.ECG is the most common method of detection of myocardial ischemia and the diagnosis of angina pectoris.
Is there any abnormality in renal function test index（Bun、Cr） after using xinyuan capsule around four weeks later?	After using xinyuan capsule around four weeks later.	Observation of whether the kidney function damage after treatment.The renal function includes creatinine,usea nitrogen.