A Registry Study on Reduning（a Chinese Medicine Injection）Used in Hospitals in China
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|ClinicalTrials.gov Identifier: NCT01824719|
Recruitment Status : Unknown
Verified April 2013 by Yanming Xie, China Academy of Chinese Medical Sciences.
Recruitment status was: Recruiting
First Posted : April 5, 2013
Last Update Posted : April 5, 2013
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.
|Condition or disease|
|Upper Respiratory Tract Infection; Acute Tracheobronchitis|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||3000 participants|
|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|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||April 2013|
|Estimated Study Completion Date :||April 2013|
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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01824719
|Institute of Basic Research in Clinical Medicine||Recruiting|
|Beijing, Beijing, China, 100700|
|Contact: Jiang J Jie 010-64014411 ext 2802 firstname.lastname@example.org|
|Principal Investigator: Xie M Yan, BA|
|Principal Investigator:||Xie Y Ming||China Academy of Chinese Medical Sciences|