- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03192748
A Registry Study of Runzaozhiyang Capsule Used in Clinical Real World
June 18, 2017 updated by: Yanming Xie, China Academy of Chinese Medical Sciences
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.
Study Overview
Status
Unknown
Conditions
Detailed Description
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.
Study Type
Observational
Enrollment (Anticipated)
3000
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 hour and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The aim population for observation is who using Runzaozhiyang capsule 's with abnormal liver function before medication from June 2017 to June 2019.
Description
Inclusion Criteria:
Patients using Runzaozhiyang capsule 's with abnormal liver function before medication from June 2017 to June 2019.
Exclusion Criteria:
none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
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 runzaozhiyang capsule around two weeks later?
Time Frame: 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.
|
After using runzaozhiyang capsule around two weeks later.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Is there any abnormality in renal function test index(Bun、Cr) after medication?
Time Frame: After using runzaozhiyang capsule around two weeks later.
|
Observation of whether the kidney function damage after treatment.The renal function includes creatinine,usea nitrogen.
|
After using runzaozhiyang capsule around two weeks later.
|
Is there any abnormality in ECG after medication?
Time Frame: After using runzaozhiyang capsule around two 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 runzaozhiyang capsule around two weeks later.
|
Is there any abnormality in basic life sign(body temperature, blood pressure and pulse)?
Time Frame: During using runzaozhiyang capsule around two 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 runzaozhiyang capsule around two weeks.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
June 19, 2017
Primary Completion (Anticipated)
June 19, 2017
Study Completion (Anticipated)
June 30, 2019
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
Other Study ID Numbers
- Runzao
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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