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

This study has been completed.
Sponsor:
Collaborators:
Shanghai Greenvalley Pharmaceutical Co., Ltd.
Peking University
Information provided by (Responsible Party):
Suodi ZHAI, Peking University Third Hospital
ClinicalTrials.gov Identifier:
NCT01872520
First received: April 13, 2013
Last updated: October 26, 2015
Last verified: October 2015
  Purpose
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
Adverse Drug Reaction

Study Type: Observational [Patient Registry]
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Peking University Third Hospital:

Primary Outcome Measures:
  • The incidence of IDSDFSY induced adverse drug reaction [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • The rare adverse drug reactions to the IDSDFSY [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The manifestation, treatment and outcomes of the ADRs [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    To describe manifestation, treatment and outcomes of the ADRs.

  • The risk factors of the ADRs [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    To examine the risk factors of the ADRs.

  • The patients' characteristics who are prescribed IDSDFSY [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    To describe the patients' characteristics who are prescribed IDSDFSY.

  • The prescribing pattern of IDSDFSY in real world clinical practice [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    To characterize the prescribing pattern of IDSDFSY in real world clinical practice.

  • Off-label use of IDSDFSY [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    To describe and evaluate the off-label use of IDSDFSY.


Enrollment: 30180
Study Start Date: June 2012
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
the Injection of DanShenDuoFenSuanYan
Patient who use the Injection of DanShenDuoFenSuanYan

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.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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 
Study First Received: April 13, 2013
Last Updated: October 26, 2015
Health Authority: China: State Administration of Traditional Chinese Medicine of the People's Republic of China

Keywords provided by 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

ClinicalTrials.gov processed this record on August 25, 2016