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

June 18, 2017 updated by: Yanming Xie, China Academy of Chinese Medical Sciences

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 hour and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

An anticipated sample size was caculated in this study, about 3000. Patients using Dazhuhongjingtian injection from 2017 to 2019 in 4 hospitals

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Dazhuhongjingtian's ADRs,especially number of participants with adverse events.
Time Frame: 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.
The registry procedure will last about 3 years only for patients using Dazhuhongjingtian

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Academy of Chinese Medical Sciences

Collaborators

Hospital of Changchun University of Traditional Chinese Medicine

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 19, 2017

Primary Completion (Anticipated)

July 19, 2017

Study Completion (Anticipated)

December 31, 2019

Study Registration Dates

First Submitted

June 14, 2017

First Submitted That Met QC Criteria

June 14, 2017

First Posted (Actual)

June 16, 2017

Study Record Updates

Last Update Posted (Actual)

June 20, 2017

Last Update Submitted That Met QC Criteria

June 18, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RSCMI-12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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