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

Completed

• Conditions: Adverse Drug Reaction

• Registration Number: NCT01872520
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-06
• Study First Submitted: 2013-04-13
• Study First Submitted QC: 2013-06-05
• Study First Posted: 2013-06-07
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-26
• Last Update Posted: 2015-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30180

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The rare adverse drug reactions to the IDSDFSY	3 years
The incidence of IDSDFSY induced adverse drug reaction	3 years

Secondary Outcome Measures

Name	Time	Method
The patients' characteristics who are prescribed IDSDFSY	3 years	To describe the patients' characteristics who are prescribed IDSDFSY.
Off-label use of IDSDFSY	3 years	To describe and evaluate the off-label use of IDSDFSY.
The manifestation, treatment and outcomes of the ADRs	3 years	To describe manifestation, treatment and outcomes of the ADRs.
The risk factors of the ADRs	3 years	To examine the risk factors of the ADRs.
The prescribing pattern of IDSDFSY in real world clinical practice	3 years	To characterize the prescribing pattern of IDSDFSY in real world clinical practice.

Trial Locations

Locations (36)

First Hospital Of Qinhuangdao; 🇨🇳 Qinhuangdao, Hebei, China

The Military General Hospital of Beijing PLA; 🇨🇳 Beijing, Beijing, China

China S.C.H.J. Hospital Of TCM; 🇨🇳 Hejiang, Sichuan, China

Minhang District Central Hospital; 🇨🇳 Shanghai, Shanghai, China

Longhua Hospital Shanghai University of TCM; 🇨🇳 Shanghai, Shanghai, China

Guang'anmen Hospital affiliatied to China Academy of Chinese Medical Sciences; 🇨🇳 Beijing, Beijing, China

Peking university third hospital; 🇨🇳 Beijing, Beijing, China

The First Affiliated Hospital of Bengbu Medical College; 🇨🇳 Bengbu, Anhui, China

The General Hospital of People's Liberation Army(301 hospital); 🇨🇳 Beijing, Beijing, China

The Second Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China

Hebei General Hospital; 🇨🇳 Shijiazhuang, Hebei, China

Wuhan Hospital of Traditional Chinese Medicine; 🇨🇳 Wuhan, Hubei, China

Wuhan Asia Heart Hospital; 🇨🇳 Wuhan, Hubei, China

Hubei Provincial Hospital of TCM; 🇨🇳 Wuhan, Hubei, China

Wuhan Integrated TCM and Western Medicine Hospital; 🇨🇳 Wuhan, Hubei, China

Weinan Central Hospital; 🇨🇳 Weinan, Shaanxi, China

Shaanxi Province Hospital of Traditional Chinese Medicine; 🇨🇳 Xi'an, Shaanxi, China

Zhangjiagang Hospital Of Traditional Chinese Medicine; 🇨🇳 Zhangjiagang, Jiangsu, China

Xijing hospital; 🇨🇳 Xi'an, Shaanxi, China

Tangdu Hospital; 🇨🇳 Xi'an, Shaanxi, China

Shaanxi Provincial People's Hospital; 🇨🇳 Xi'an, Shaanxi, China

Shanghai Huangpu District Central Hospital; 🇨🇳 Shanghai, Shanghai, China

Yanan University Affiliated Hospital; 🇨🇳 Yan'an, Shaanxi, China

Shuguang Hospital Shanghai University of Traditional Chinese Medicine; 🇨🇳 Shanghai, Shanghai, China

Central Hospital Of Qingpu District, Shanghai; 🇨🇳 Shanghai, Shanghai, China

Huashan Hospital Fudan University; 🇨🇳 Shanghai, Shanghai, China

Sichuan 2nd Hospital Of TCM; 🇨🇳 Chengdu, Sichuan, China

Hospital Of Chengdu Office Of People's Government of Tibetan Autonomous Region (Hospital.C.T.); 🇨🇳 Chengdu, Sichuan, China

Affiliated Hospital of Chengdu University; 🇨🇳 Chengdu, Sichuan, China

The First Affiliated Hospital of the Medical College, Shihezi University; 🇨🇳 Shihezi, Xinjiang, China

AVIC 363 Hospital; 🇨🇳 Chengdu, Sichuan, China

The Fifth Affiliated Hospital of Xinjiang Medical University; 🇨🇳 Urumqi, Xinjiang, China

Chest Hospital of Xinjiang Uygur Autonomous Region; 🇨🇳 Urumqi, Xinjiang, China

Traditional Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region; 🇨🇳 Urumqi, Xinjiang, China

People's Hospital of Xinjiang Uygur Autonomous Region; 🇨🇳 Urumqi, Xinjiang, China

The First Affiliated Hospital of Xinjiang Medical University; 🇨🇳 Urumqi, Xinjiang, China