A Registry Study of Sanwujiaowan Capsule Used in Clinical Real World

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

Study Overview

• Status: Unknown
• Conditions: Osteoarthritis; Rheumatism

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 Sanwujiaowan capsule 's with abnormal liver function before medication from June 2017 to December 2018.

• Study Type: Observational
• Enrollment (Anticipated): 3000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 hour and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The aim population for observation is who using Sanwujiaowan capsule 's with abnormal liver function before medication from June 2017 to December 2018.

Description

Inclusion Criteria:

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

Exclusion Criteria:

NONE

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Is there any abnormality in liver function test index（ALT、AST、TBil、GGT） after using sanwujiaowan 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.	After using sanwujiaowan capsule around four weeks later

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Is there any abnormality in renal function test index（Bun、Cr） after using sanwujiaowan capsule around four weeks later?	Observation of whether the kidney function damage after treatment.The renal function includes creatinine,usea nitrogen.	After using sanwujiaowan capsule around four weeks later.
Is there any abnormality in ECG after using sanwujiaowan 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.	After using sanwujiaowan capsule around four weeks later.
Is there any abnormality in basic life sign（body temperature, blood pressure and pulse）during using sanwujiaowan 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.	During using sanwujiaowan capsule around four weeks.

Collaborators and Investigators

• Sponsor: Yanming Xie
• Collaborators: Xiangya Hospital of Central South University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 19, 2017
• Primary Completion (ANTICIPATED): June 19, 2017
• Study Completion (ANTICIPATED): December 31, 2018

Study Registration Dates

• First Submitted: June 14, 2017
• First Submitted That Met QC Criteria: June 18, 2017
• First Posted (ACTUAL): June 20, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 20, 2017
• Last Update Submitted That Met QC Criteria: June 18, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Connective Tissue Diseases; Rheumatic Diseases
• Other Study ID Numbers: Sanwujiaowan

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No