NCT03189199

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

A Registry Study on Safety Surveillance of Dazhuhongjingtian (a Chinese Medicine

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 3,000 (estimated)
• Sponsor: China Academy of Chinese Medical Sciences · Academic / Other
• Sex: All
• Age: 1 Hour
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Heart Disease

Interventions

Type	Name	Description
OTHER	a 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.

Timeline

• Start date: 2017-06-19
• Primary completion: 2017-07-19
• Completion: 2019-12-31
• First posted: 2017-06-16
• Last updated: 2017-06-20