A Registry Study on Shuxuetong (a Chinese Medicine Injection) Used in Twenty Hospitals (RSCMI-I)
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
This is the first academic registry study about adverse events or adverse drug reaction for Chinese medicine injection in mainland China.
It is well known that Chinese medicine injection is just limited in mainland China, which also be accepted by China health care system.
However, more and more adverse events or adverse drug reaction have been reported in recent years in the form of case report.
In order to improving monitoring adverse events or adverse drug reaction of Chinese medicine injection in hospital, registry study will be introduced in this area.
To calculate the incidence of adverse events or adverse drug reaction is one of the main aims for this study.
According to the 'rule of three', 30,000 cases need to be registered at least.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
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Beijing
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Beijing, Beijing, Kina, 100700
- Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- all inpatients use Shuxuetong injection in 20 selected hospitals during their hospital stay
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Shuxuetong injection
a cohort using Shuxuetong injection
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number of participants with adverse events; incidence of Shuxuetong'ADRs and identify factors that contributed to the occurrence of the adverse reaction
Tidsramme: to assess Shuxuetong's "adverse event" and "drug adverse reaction" during patients' hospital stay, administration information of Shuxuetong will be registered every day. The registry procedure will last 3 years only for patients using Shuxuetong.
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All participants will be followed for the duration of hospital stay, an expected average of 2 weeks.Patients using Shuxuetong will be registered on a registration form including disease background, Shuxuetong'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 Shuxuetong.
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to assess Shuxuetong's "adverse event" and "drug adverse reaction" during patients' hospital stay, administration information of Shuxuetong will be registered every day. The registry procedure will last 3 years only for patients using Shuxuetong.
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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Yan M Xie, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2009zx09502-030
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