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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01781676
Recruitment Status : Unknown
Verified April 2013 by Yanming Xie, China Academy of Chinese Medical Sciences.
Recruitment status was:  Active, not recruiting
First Posted : February 1, 2013
Last Update Posted : May 14, 2013
Longhua Hospital
Information provided by (Responsible Party):
Yanming Xie, China Academy of Chinese Medical Sciences

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 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.

Condition or disease
Coronary Heart Disease Angina Pectoris Stroke

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 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.

Study Type : Observational [Patient Registry]
Estimated Enrollment : 30000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 14 Days
Official Title: Registry Study Intensive Hospital Monitoring Protocol of Kudiezi Injection ( Yueanxin ) 's Clinical Safety
Study Start Date : January 2012
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Number of participants with adverse events;incidence of Kudiezi(Yueanxin)'ADRs and identify factors that contributed to the occurrence of the adverse reaction [ Time Frame: 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. ]
    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).

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
An anticpcipated sample size was caculated in this study,about 30000.Patients using Kudiezi injection from 2012 to 2014 in more than 20 hospital.

Inclusion Criteria:

Patients using Kudiezi(Yueanxin) injection from 2012 to 2014

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01781676

China, Beijing
Institute of Basic Research in Clinical Medicine
Beijing, Beijing, China, 100700
Sponsors and Collaborators
China Academy of Chinese Medical Sciences
Longhua Hospital
Principal Investigator: Xie Y Ming, BA China Academy of Chinese Medical Sciences

Responsible Party: Yanming Xie, Deputy Director, China Academy of Chinese Medical Sciences Identifier: NCT01781676     History of Changes
Other Study ID Numbers: RSCMI-Ⅷ
First Posted: February 1, 2013    Key Record Dates
Last Update Posted: May 14, 2013
Last Verified: April 2013

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Angina Pectoris
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Chest Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms