Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-01-02 @ 5:00 PM
Study NCT ID:
NCT01612559
Status:
UNKNOWN
Last Update Posted:
2012-06-06
First Post:
2012-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of Kudiezi (a Chinese Medicine Injection) Used in Hospitals in China
Sponsor:
China Academy of Chinese Medical Sciences
Organization:
Study Overview
Official Title:
A Registry Study on Safety Surveillance of Kudiezi (a Chinese Medicine Injection) Used in China
Status:
UNKNOWN
Status Verified Date:
2012-06
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RSCMI-Ⅱ
Brief Summary:
This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in October 2011.
It was funded by China major scientific and technological specialized project for 'significant new formulation of new drugs'.
Kudiezi is kind of Chinese Medicine injection used for treating coronary heart disease and angina pectoris in many Chinese hospitals.
The purpose of this study is to determine adverse drug events or adverse drug reaction in large sample size 30,000 patients.
It was funded by China major scientific and technological specialized project for 'significant new formulation of new drugs'.
Kudiezi is kind of Chinese Medicine injection used for treating coronary heart disease and angina pectoris in many Chinese hospitals.
The purpose of this study is to determine adverse drug events or adverse drug reaction in large sample size 30,000 patients.
Detailed Description:
It is very common that Chinese Medicine Injection used in hospitals in mainland China. However safety problems rose in recent years. There could be many uncertain factors influence Chinese Medicine Injection in clinical practice.
Safety surveillance on Chinese Medicine injection is an important problem that needs to be sorted out through large sample observational study.
A registry study for Kudiezi injection safety surveillance with 30000 patients will be conducted from Jan.2012 to Dec.2015.
Eligibility criteria Patients who will use Kudiezi injection in selected hospitals
Data will be collected in four aspects by four different forms as following:
Form A (blue): demographic information Form B (yellow): adverse drug events/reaction Form C (white): extracted information from hospital information system and laboratory information system Form D (red): personalized information
Safety surveillance on Chinese Medicine injection is an important problem that needs to be sorted out through large sample observational study.
A registry study for Kudiezi injection safety surveillance with 30000 patients will be conducted from Jan.2012 to Dec.2015.
Eligibility criteria Patients who will use Kudiezi injection in selected hospitals
Data will be collected in four aspects by four different forms as following:
Form A (blue): demographic information Form B (yellow): adverse drug events/reaction Form C (white): extracted information from hospital information system and laboratory information system Form D (red): personalized information
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| RSCMI-Ⅱ | REGISTRY | Registry study on Chinese Medicine Injection | View |