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

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ClinicalTrials.gov Identifier: NCT01872520
Recruitment Status : Completed
First Posted : June 7, 2013
Last Update Posted : October 27, 2015
Sponsor:
Collaborators:
Shanghai Greenvalley Pharmaceutical Co., Ltd.
Peking University
Information provided by (Responsible Party):
Suodi ZHAI, Peking University Third Hospital

Brief Summary:
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.

Condition or disease
Adverse Drug Reaction

Detailed Description:

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.


Study Type : Observational [Patient Registry]
Actual Enrollment : 30180 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Weeks
Official Title: Post-marketing Safety Surveillance of the Injection of DanShenDuoFenSuanYan (the Injection of Depsides Salts From Salvia Miltiorrhiza): A Real World Study
Study Start Date : June 2012
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

Group/Cohort
the Injection of DanShenDuoFenSuanYan
Patient who use the Injection of DanShenDuoFenSuanYan



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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))
Criteria

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:


Information from the National Library of Medicine

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): NCT01872520


  Show 36 Study Locations
Sponsors and Collaborators
Peking University Third Hospital
Shanghai Greenvalley Pharmaceutical Co., Ltd.
Peking University
Investigators
Study Chair: Suodi ZHAI, B.S. Peking University Third Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Suodi ZHAI, Suodi ZHAI, Department of Pharmacy, Peking University Third Hospital, Peking University Third Hospital
ClinicalTrials.gov Identifier: NCT01872520     History of Changes
Other Study ID Numbers: PekingUTH-Pharmacy-001
First Posted: June 7, 2013    Key Record Dates
Last Update Posted: October 27, 2015
Last Verified: October 2015

Keywords provided by Suodi ZHAI, Peking University Third Hospital:
the Injection of DanShenDuoFenSuanYan
Magnesium Lithospermate B
Safety
Real World Study

Additional relevant MeSH terms:
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders