An observational study in Eczema, sponsored by China Academy of Chinese Medical Sciences. Status unknown. Open to participants aged 1 Hour and older. Per ClinicalTrials.gov, last updated 2017-06-20.
Sponsored by China Academy of Chinese Medical Sciences · Observational
The purpose of this study is get to know what and how Runzaozhiyang capsule in hospital results in drug-induced liver injury or adverse drug reactions from a cohort event monitoring as registration research.
In order to improving monitoring drug-induced liver injury or adverse drug reactions of Chinese medicine containing Radix Polygoni Multiflori in clinical real world, 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 Runzaozhiyang capsule 's with abnormal liver function before medication from June 2017 to June 2019.
1,084 studies on the registry are indexed under Eczema; 137 are open to participants now.
This study's planned enrollment of 3,000 is above the median of 100 across 168 observational studies indexed under Eczema.
Browse Eczema studies →China Academy of Chinese Medical Sciences is the lead sponsor of 61 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The aim population for observation is who using Runzaozhiyang capsule 's with abnormal liver function before medication from June 2017 to June 2019.
Patients using Runzaozhiyang capsule 's with abnormal liver function before medication from June 2017 to June 2019.
Exclusion Criteria:
none
Is there any abnormality in liver function test index（ALT、AST、TBil、GGT） after using runzaozhiyang capsule around two 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.
Time frame: After using runzaozhiyang capsule around two weeks later.
Is there any abnormality in renal function test index（Bun、Cr） after medication?
Observation of whether the kidney function damage after treatment.The renal function includes creatinine,usea nitrogen.
Time frame: After using runzaozhiyang capsule around two weeks later.
Is there any abnormality in ECG after medication?
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.
Time frame: After using runzaozhiyang capsule around two weeks later.
Is there any abnormality in basic life sign（body temperature, blood pressure and pulse）？
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.
Time frame: During using runzaozhiyang capsule around two weeks.
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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China Academy of Chinese Medical Sciences