A Registry Study on Reduning（a Chinese Medicine Injection）Used in Hospitals in China
a Study of Clinical Safety Monitoring and the Mechanism of Anaphylactic Reaction Used Reduning(a Chinese Medicine Injection)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.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studieorter
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Beijing
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Beijing, Beijing, Kina, 100700
- Rekrytering
- Institute of Basic Research in Clinical Medicine
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Huvudutredare:
- Xie M Yan, BA
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Kontakt:
- Jiang J Jie
- Telefonnummer: 2802 010-64014411
- E-post: studentjiangjunjie@tom.com
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Patients using Reduning injection from January to March 2013
Exclusion Criteria:
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Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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Allergic group
All patients who used Reduning Injection have anaphylaxis.
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Control group
All patients who used Reduning Injection don't have anaphylaxis.One allergic group patient should matched four control group patients.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
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Number of participants with anaphylactic reaction;the blood routine examination of participants with anaphylactic reaction
Tidsram: 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
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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
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Samarbetspartners och utredare
Utredare
- Huvudutredare: Xie Y Ming, China Academy of Chinese Medical Sciences
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 200907001-5-6-1
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