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Post-marketing Safety Surveil...

Post-marketing Safety Surveillance of the Injection of DanShenDuoFenSuanYan A Real World Study

Last Updated: 2015-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2015-09-30

Brief Summary

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Magnesium Lithospermate B, the main constituent of the Injection of DanShenDuoFenSuanYan (the Injection of Depsides Salts From Salvia Miltiorrhiza), is the active ingredient of Salvia Miltiorrhiza. This study record clinical use of The injection of DanShenDuoFenSuanYan in the real world, and observe the adverse drug reactions/ adverse drug events during treatment.

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Detailed Description

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As a traditional chinese medicine, the Injection of DanShenDuoFenSuanYan (the Injection of Depsides Salts From Salvia Miltiorrhiza) was approved by State Food and Drug Administration of China in May,2005. This cardiovascular drug is one of the few Traditional Chinese Medicine pharmaceuticals where the active ingredients have been identified in the molecular levels. In its 8 years marketing in China, there is no serious adverse drug reactions.

In this study, clinical pharmacists in selected hospitals will record the clinical use and the adverse drug reactions/ adverse drug events of this injection.

This real world study for the Injection of DanShenDuoFenSuanYan with 30400 patients will be conducted from June.2012 to May.2014.

Conditions

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Adverse Drug Reaction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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the Injection of DanShenDuoFenSuanYan

Patient who use the Injection of DanShenDuoFenSuanYan

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients who use the Injection of DanShenDuoFenSuanYan in 30 hospitals in china(including the inpatient and the outpatient(only in some hospitals which can get the information)).

Exclusion Criteria

* none

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Suodi ZHAI

Suodi ZHAI, Department of Pharmacy, Peking University Third Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Suodi ZHAI, B.S.

Role: STUDY_CHAIR

Peking University Third Hospital

Locations

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The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Site Status

Guang'anmen Hospital affiliatied to China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, China

Site Status

Peking university third hospital

Beijing, Beijing Municipality, China

Site Status

The Military General Hospital of Beijing PLA

Beijing, Beijing Municipality, China

Site Status

The General Hospital of People's Liberation Army(301 hospital)

Beijing, Beijing Municipality, China

Site Status

First Hospital Of Qinhuangdao

Qinhuangdao, Hebei, China

Site Status

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Site Status

Hebei General Hospital

Shijiazhuang, Hebei, China

Site Status

Wuhan Hospital of Traditional Chinese Medicine

Wuhan, Hubei, China

Site Status

Wuhan Asia Heart Hospital

Wuhan, Hubei, China

Site Status

Wuhan Integrated TCM and Western Medicine Hospital

Wuhan, Hubei, China

Site Status

Hubei Provincial Hospital of TCM

Wuhan, Hubei, China

Site Status

Zhangjiagang Hospital Of Traditional Chinese Medicine

Zhangjiagang, Jiangsu, China

Site Status

Weinan Central Hospital

Weinan, Shaanxi, China

Site Status

Tangdu Hospital

Xi'an, Shaanxi, China

Site Status

Xijing hospital

Xi'an, Shaanxi, China

Site Status

Shaanxi Province Hospital of Traditional Chinese Medicine

Xi'an, Shaanxi, China

Site Status

Shaanxi Provincial People's Hospital

Xi'an, Shaanxi, China

Site Status