Coronary Heart Disease
Conditions
Brief summary
The purpose of this study is to make a cohort event monitoring to see whether and how Dazhuhongjingtian injection in hospital results in adverse events or adverse drug reactions
Detailed description
Safety surveillance on Chinese Medicine injection is an important problem that needs to be sorted out ,because in mainland China hospitals ,Chinese Medicine Injection are used widely. Population for taking medicine characteristics,the incidence rate of ADR and other uncertain factors influence can few be found now.A registry study for Dazhuhongjingtian injection safety surveillance with 3000 patients will be conducted from June.2017 to Dec.2019.Eligibility criteria Patients who will use Dazhuhongjingtian injection in 4 selected hospitals from2017-2019.
Interventions
OTHERa cohort using Dazhuhongjingtian injection
All patients will be measured and assessed at the time Dazhuhongjingtian Injection is administered to them until they discharge. Patients using Dazhuhongjingtian Injection will be registered on a registration form including disease background, Dazhuhongjingtian Injection'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 Dazhuhongjingtian Injection.
Sponsors
Hospital of Changchun University of Traditional Chinese Medicine
China Academy of Chinese Medical Sciences
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Hours to No maximum
Healthy volunteers
No
Inclusion criteria
\- An anticipated sample size was caculated in this study, about 3000. Patients using Dazhuhongjingtian injection from 2017 to 2019 in 4 hospitals
Exclusion criteria
none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Dazhuhongjingtian's ADRs,especially number of participants with adverse events. | The registry procedure will last about 3 years only for patients using Dazhuhongjingtian | All patients will be measured and assessed at the time Dazhuhongjingtian is administered to them until they discharge. Patients using Dazhuhongjingtian will be registered on a registration form including disease background, Dazhuhongjingtian'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 Dazhuhongjingtian. |
Contacts
Primary ContactYan Ming Xie, BA
Backup ContactLian Xin Wang, doctor
Outcome results
None listed