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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Peking University Third Hospital
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: June 5, 2013
Last verified: June 2013
  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

Further study details as provided by Peking University Third Hospital:

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

Estimated Enrollment: 30400
Study Start Date: June 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (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

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:

  • none
  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

Contacts
Contact: Suodi ZHAI +8615611908515 zhaisuodi@163.com

Locations
China, Beijing
Peking university third hospital Recruiting
Beijing, Beijing, China, 100191
Contact: Suodi ZHAI, B.S.    +8615611908515    zhaisuodi@163.com   
Principal Investigator: Suodi ZHAI, B.S.         
Sponsors and Collaborators
Suodi ZHAI
Shanghai Greenvalley Pharmaceutical Co., Ltd.
Peking University
  More Information

No publications provided

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: June 5, 2013
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 Toxicity
Poisoning
Substance-Related Disorders
Lithospermate B
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 29, 2014