Safety Study of Kudiezi (a Chinese Medicine Injection) Used in Hospitals in China

Coronary Heart Disease Clinical Trial

— RSCMI-?  

Official title:

A Registry Study on Safety Surveillance of Kudiezi (a Chinese Medicine Injection) Used in China

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01612559
• Other study ID #: RSCMI-?
• Secondary ID: RSCMI-?
• Status: Unknown status
• Phase: N/A
• First received: June 3, 2012
• Last updated: June 3, 2012
• Start date: January 2012
• Est. completion date: December 2015

Study information

• Verified date: June 2012
• Source: China Academy of Chinese Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 30000
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients using Kudiezi injection from 2012 to 2014

Exclusion Criteria:

Related Conditions & MeSH terms

• Angina Pectoris
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
China Academy of Chinese Medical Sciences	Dongfang Hospital Affiliated to Beijing University of Chinese Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events; incidence of Kudiezi'ADRs and identify factors that contributed to the occurrence of the adverse reaction	All patients will be measured and assessed at the time Kudiezi is administered to them until they discharge. Patients using Kudiezi will be registered on a registration form including disease background, Kudiezi's administration, and extraction information from hospital information system. An adverse event or drug adverse reaction form also will be used to describe any doubted symptoms or signs from patients. A judgment will be made by doctors directly and a further analysis will be conducted by researchers to decide those potential side effects of Kudiezi.	to assess Kudiezi's 'adverse event' and 'drug adverse reaction' during patients' hospital stay, administration information of Kudiezi will be registered every day. The registry procedure will last 3 years only for patients using Kudiezi.