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NCT Number: NCT01872520

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

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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Key information

Conditions

Adverse Drug Reaction Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The incidence of IDSDFSY induced adverse drug reaction

    Time frame: 3 years

  2. The rare adverse drug reactions to the IDSDFSY

    Time frame: 3 years

Secondary outcomes

  1. The manifestation, treatment and outcomes of the ADRs

    Time frame: 3 years

    To describe manifestation, treatment and outcomes of the ADRs.

  2. The risk factors of the ADRs

    Time frame: 3 years

    To examine the risk factors of the ADRs.

  3. The patients' characteristics who are prescribed IDSDFSY

    Time frame: 3 years

    To describe the patients' characteristics who are prescribed IDSDFSY.

  4. The prescribing pattern of IDSDFSY in real world clinical practice

    Time frame: 3 years

    To characterize the prescribing pattern of IDSDFSY in real world clinical practice.

  5. Off-label use of IDSDFSY

    Time frame: 3 years

    To describe and evaluate the off-label use of IDSDFSY.

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Collaborators

  • Peking University
  • Shanghai Greenvalley Pharmaceutical Co., Ltd.

Registry information

Official study title

Post-marketing Safety Surveillance of the Injection of DanShenDuoFenSuanYan (the Injection of Depsides Salts From Salvia Miltiorrhiza): A Real World Study

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jun 7, 2013
Registry last updated
Oct 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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