A Registry Study of Sanwujiaowan Capsule Used in Clinical Real World
1 other identifier
observational
3,000
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2017
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2017
CompletedStudy Start
First participant enrolled
June 19, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 19, 2017
CompletedFirst Posted
Study publicly available on registry
June 20, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedJune 20, 2017
June 1, 2017
Same day
June 14, 2017
June 18, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Is there any abnormality in renal function test index（Bun、Cr） after using sanwujiaowan capsule around four weeks later?
After using sanwujiaowan capsule around four weeks later.
Is there any abnormality in ECG after using sanwujiaowan capsule around four weeks later?
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？
During using sanwujiaowan capsule around four weeks.
Eligibility Criteria
The aim population for observation is who using Sanwujiaowan capsule 's with abnormal liver function before medication from June 2017 to December 2018.
You may qualify if:
- Patients using Sanwujiaowan capsule 's with abnormal liver function before medication from June 2017 to December 2018.
You may not qualify if:
- NONE
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yanming Xielead
- Xiangya Hospital of Central South Universitycollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yanming Xie, BA
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Deputy Director
Study Record Dates
First Submitted
June 14, 2017
First Posted
June 20, 2017
Study Start
June 19, 2017
Primary Completion
June 19, 2017
Study Completion
December 31, 2018
Last Updated
June 20, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share