A Registry Study on Shuxuetong (a Chinese Medicine Injection) Used in Twenty Hospitals

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01508403

Acronym

RSCMI-I

Enrollment

30000

Registered

2012-01-12

Start date

2012-01-31

Completion date

2015-12-31

Last updated

2013-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke

Brief summary

The purpose of this study is to make a cohort event monitoring to see whether and how Shuxuetong injection in hospital results in adverse events or adverse drug reactions.

Detailed description

This is the first academic registry study about adverse events or adverse drug reaction for Chinese medicine injection in mainland China. It is well known that Chinese medicine injection is just limited in mainland China, which also be accepted by China health care system. However, more and more adverse events or adverse drug reaction have been reported in recent years in the form of case report. In order to improving monitoring adverse events or adverse drug reaction of Chinese medicine injection in hospital, registry study will be introduced in this area. To calculate the incidence of adverse events or adverse drug reaction is one of the main aims for this study. According to the 'rule of three', 30,000 cases need to be registered at least.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* all inpatients use Shuxuetong injection in 20 selected hospitals during their hospital stay

Design outcomes

Primary

Measure	Time frame	Description
Number of participants with adverse events; incidence of Shuxuetong'ADRs and identify factors that contributed to the occurrence of the adverse reaction	to assess Shuxuetong's adverse event and drug adverse reaction during patients' hospital stay, administration information of Shuxuetong will be registered every day. The registry procedure will last 3 years only for patients using Shuxuetong.	All participants will be followed for the duration of hospital stay, an expected average of 2 weeks.Patients using Shuxuetong will be registered on a registration form including disease background, Shuxuetong'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 Shuxuetong.

Countries

China

Outcome results