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

Stroke Clinical Trial

Official title:

Registry Study Intensive Hospital Monitoring Protocol of Kudiezi Injection ( Yueanxin ) 's Clinical Safety

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01781676
• Other study ID #: RSCMI-?
• Status: Active, not recruiting
• Phase: N/A
• First received: January 30, 2013
• Last updated: May 13, 2013
• Start date: January 2012
• Est. completion date: December 2015

Study information

• Verified date: April 2013
• Source: China Academy of Chinese Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: State Administration of Traditional Chinese Medicine of the People's Republic of China
• Study type: Observational [Patient Registry]

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 specialized project for 'significant new formulation of net drugs'.

Kudiezi(Yueanxin) is kind of Chinese Medicine injiection used for treating corinary heart diswese、angina pectoris and stroke 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 Medincine Injection in clinical practice.

Safety surveillance on Chinese Medincine injection is an important problem that needs to be sorted out through large sample observational dtudy.

A registry study for Kudiezi(Yueanxin) injection safety surveillance with 30000 patients will be conducted form Jan.2012 to Dec.2015.

Eligiblity crteria Patients who will use Kudiezi(Yueanxin) injection in selected hospitals.

Date will be collected in four aspects by four different forms as following:

Form A(blue):demographic information ;Form B(yellow):adverde drug events/reaction;Form C(white):extracted information from hodpiral information system and laboratory information system.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30000
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Patients using Kudiezi(Yueanxin) injection from 2012 to 2014

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
China	Institute of Basic Research in Clinical Medicine	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
China Academy of Chinese Medical Sciences	Longhua Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events;incidence of Kudiezi(Yueanxin)'ADRs and identify factors that contributed to the occurrence of the adverse reaction	All patients will be measured and assessed at the time Kudiezi(Yueanxin) is adminnistered to them until they discharge.Patients using Kudiezi(Yueanxin) will be registered on a regisration form including disease background, Kudiezi(Yueanxin)'s adminidtration,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(Yueanxin).	to assess Kudiezi(Yueanxin)'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.	Yes