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

NCT03189199 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 3000

Last updated 2017-06-20

No results posted yet for this study

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Hospital of Changchun University of Traditional Chinese Medicine

    collaborator UNKNOWN

  • China Academy of Chinese Medical Sciences

    lead OTHER

Principal Investigators

  • Yan Ming Xie, BA · Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

Eligibility

Min Age
1 Hour
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-19
Primary Completion
2017-07-19
Completion
2019-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03189199 on ClinicalTrials.gov