A Registry Study on Reduning（a Chinese Medicine Injection）Used in Hospitals in China
This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in January 2013.
The purpose of this study is to make a event monitoring to see whether Reduning injection is safe and the characteristic and mechanism of anaphylactic reaction used Reduning injection in hospitals in China.
Upper Respiratory Tract Infection;
|Study Type:||Observational [Patient Registry]|
|Study Design:||Time Perspective: Prospective|
|Target Follow-Up Duration:||15 Days|
|Official Title:||a Study of Clinical Safety Monitoring and the Mechanism of Anaphylactic Reaction Used Reduning(a Chinese Medicine Injection)in Hospitals in China|
- Number of participants with anaphylactic reaction;the blood routine examination of participants with anaphylactic reaction [ Time Frame: to assess Reduning's 'anaphylactic reaction' .during patients' hospital stay, administration information of Reduning will be registered every day. The registry procedure will last 3 month only for patients using Reduning ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||April 2013|
|Estimated Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
All patients who used Reduning Injection have anaphylaxis.
All patients who used Reduning Injection don't have anaphylaxis.One allergic group patient should matched four control group patients.
It is very common that Chinese Medicine Injection used in hospitals in mainland China. However safety problems rose in recent years. There could be many uncertain factors influence Chinese Medicine Injection in clinical practice.
In order to ensure the safety of public drug use and lower drug-induced risks, a registry study for Reduning injection safety surveillance with 3000 patients will be conducted from Jan.2013 to Mar.2013.At the same time,Patients who have anaphylactic reaction are selected as the allergic group and not have anaphylactic reaction are selected as the control group.The proportion of allergic group and control group is 1:4.All the patients who are selected should draw blood.
Eligibility criteria Patients who will use Reduning injection in selected hospitals.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01824719
|Institute of Basic Research in Clinical Medicine||Recruiting|
|Beijing, Beijing, China, 100700|
|Contact: Jiang J Jie 010-64014411 ext 2802 email@example.com|
|Principal Investigator: Xie M Yan, BA|
|Principal Investigator:||Xie Y Ming||China Academy of Chinese Medical Sciences|