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A Registry Study of Shuxuening Injection Used in Hospitals in China (RSCMI-VII)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Beijing University of Chinese Medicine
Information provided by (Responsible Party):
Xie Yanming, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier:
NCT01752946
First received: December 15, 2012
Last updated: December 19, 2012
Last verified: December 2012
  Purpose

The purpose of this study is get to know what and how Shuxuening injection in hospital results in adverse events or adverse drug reactions from a cohort event monitoring.


Condition
Coronary Disease
Intracranial Embolism
Stroke
Angina Pectoris
Vasospasm

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Registry Study of Shuxuening (a Chinese Medicine Injection) Used in Hospitals in China

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Incidence of Shuxuening injection's ADRs and factors contributed to the occurrence of the adverse reaction [ Time Frame: to assess Shuxuening's "adverse event" and "drug adverse reaction" during patients' hospital stay, administration information of Shuxuening will be registered every day. The registry procedure will last 2 years only for patients using Shuxuening. ] [ Designated as safety issue: Yes ]
    All participants will be followed for the duration of hospital stay, an expected average of 2 weeks. Patients using Shuxuening will be registered on a registration form including disease background, Shuxuening's administration, and extraction information from hospital information system. When the patients occurs allergic reaction during using Shuxuening injection, it also need to collect patient's biological samples. 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 Shuxuening injection.


Estimated Enrollment: 30000
Study Start Date: October 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Detailed Description:

Ginkgo leaf is major component of Shuxuening injection. Although some western countries product similar injections and use them, Shuxuening injection also regarded as Chinese medicine injection. As a TCM injection, the most important thing is how to safety use it in practice.

In order to improving monitoring adverse events or adverse drug reaction of Chinese medicine injection in hospital, registry study is suitable method in this area. Otherwise, nested case control study is used to find out the mechanism of allergic reaction.

Calculate the incidence of adverse events or adverse drug reaction is one of the main aims for this study. Safety surveillance on Chinese Medicine injection is an important problem that needs to be sorted out through large sample observational study.

According to the 'rule of three', 30,000 cases need to be registered at least. The aim population is who using Shuxuening injection's during inpatient time from December 2012 to December 2014.

Data will be collected for three departments as following:

Form A (green): demographic information ;Form B (pink): adverse drug events/reaction; Form C (white): extracted information from hospital information system and laboratory information system.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

According to the 'rule of three', 30,000 cases need to be registered at least. The aim population is who using Shuxuening injection's during inpatient time from December 2012 to December.2014 in more than 30 hospitals in China.

Criteria

Inclusion Criteria:

  • Patients using Shuxuening 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: NCT01752946

Sponsors and Collaborators
China Academy of Chinese Medical Sciences
Beijing University of Chinese Medicine
Investigators
Principal Investigator: Yan M Xie, BA Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
  More Information

No publications provided

Responsible Party: Xie Yanming, Deputy Director, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT01752946     History of Changes
Other Study ID Numbers: 2009zx09502-030-07
Study First Received: December 15, 2012
Last Updated: December 19, 2012
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
Intracranial Embolism
Arterial Occlusive Diseases
Arteriosclerosis
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Chest Pain
Embolism and Thrombosis
Heart Diseases
Intracranial Embolism and Thrombosis
Myocardial Ischemia
Nervous System Diseases
Pain
Signs and Symptoms
Thromboembolism
Thrombosis
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014