Osteoarthritis Clinical Trial
Official title:
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.
Status | Not yet recruiting |
Enrollment | 3000 |
Est. completion date | December 31, 2018 |
Est. primary completion date | June 19, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: Patients using Sanwujiaowan capsule 's with abnormal liver function before medication from June 2017 to December 2018. Exclusion Criteria: |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Yanming Xie | Xiangya Hospital of Central South University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | |
Secondary | 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. | |
Secondary | 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. |
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