A Registry Study on Safety Surveillance of Dazhuhongjingtian (a Chinese Medicine Injection) Used in China

• Conditions: Coronary Heart Disease

• Registration Number: NCT03189199
• Lead Sponsor: China Academy of Chinese Medical Sciences

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.

Study Timeline

• Status Verified: 2017-06
• Study First Submitted: 2017-06-14
• Study First Submitted QC: 2017-06-14
• Study First Posted: 2017-06-16
• Last Update Submitted: 2017-06-18
• Study Start: 2017-06-19
• Last Update Posted: 2017-06-20
• Primary Completion: 2017-07-19
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.