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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Longhua Hospital
Information provided by (Responsible Party):
Yanming Xie, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier:
NCT01781676
First received: January 30, 2013
Last updated: May 13, 2013
Last verified: April 2013
  Purpose

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
Coronary Heart Disease
Angina Pectoris
Stroke

Study Type: Observational [Patient Registry]
Study Design: 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

Resource links provided by NLM:


Further study details as provided by China Academy of Chinese Medical Sciences:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]
    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).


Estimated Enrollment: 30000
Study Start Date: January 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
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.

Criteria

Inclusion Criteria:

Patients using Kudiezi(Yueanxin) injection from 2012 to 2014

Exclusion Criteria:

none

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01781676

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

No publications provided

Responsible Party: Yanming Xie, Deputy Director, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT01781676     History of Changes
Other Study ID Numbers: RSCMI-Ⅷ
Study First Received: January 30, 2013
Last Updated: May 13, 2013
Health Authority: China: State Administration of Traditional Chinese Medicine of the People's Republic of China

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

ClinicalTrials.gov processed this record on October 21, 2014