Adverse Drug ReactionNCT01872520
Post-marketing Safety Surveillance of the Injection of DanShenDuoFenSuanYan A Real World Study
An observational study of Adverse Drug Reaction, run by Peking University Third Hospital at 36 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Adverse Drug Reaction
- Type of treatment
- Injection or infusion
- How many people
- 30,180 participants
- Where
- 36 sitesChina
- Study dates
- Jun 2012to Sep 2015
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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))
Who may be able to join
- 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)).
Who cannot join
- none
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
China36 sites
Guang'anmen Hospital affiliatied to China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100053
Peking university third hospital
Beijing, Beijing Municipality, 100191
The Military General Hospital of Beijing PLA
Beijing, Beijing Municipality, 100700
The General Hospital of People's Liberation Army(301 hospital)
Beijing, Beijing Municipality, 100853
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233004
Sichuan 2nd Hospital Of TCM
Chengdu, Sichuan, 610031
Hospital Of Chengdu Office Of People's Government of Tibetan Autonomous Region (Hospital.C.T.)
Chengdu, Sichuan, 610041
Affiliated Hospital of Chengdu University
Chengdu, Sichuan, 610081
AVIC 363 Hospital
Chengdu, Sichuan
China S.C.H.J. Hospital Of TCM
Hejiang, Sichuan, 646200
First Hospital Of Qinhuangdao
Qinhuangdao, Hebei, 66000
Shanghai Huangpu District Central Hospital
Shanghai, Shanghai Municipality, 200002
Shuguang Hospital Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200021
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, 200031
Longhua Hospital Shanghai University of TCM
Shanghai, Shanghai Municipality, 200032
Minhang District Central Hospital
Shanghai, Shanghai Municipality, 201100
Central Hospital Of Qingpu District, Shanghai
Shanghai, Shanghai Municipality, 201700
The First Affiliated Hospital of the Medical College, Shihezi University
Shihezi, Xinjiang, 832008
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
Hebei General Hospital
Shijiazhuang, Hebei, 50051
The Fifth Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830000
Traditional Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, 830000
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, 830001
Chest Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, 830049
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830054
Weinan Central Hospital
Weinan, Shaanxi
Wuhan Hospital of Traditional Chinese Medicine
Wuhan, Hubei, 430014
Wuhan Asia Heart Hospital
Wuhan, Hubei, 430022
Wuhan Integrated TCM and Western Medicine Hospital
Wuhan, Hubei, 430022
Hubei Provincial Hospital of TCM
Wuhan, Hubei, 430061
Tangdu Hospital
Xi'an, Shaanxi, 710000
Xijing hospital
Xi'an, Shaanxi, 710000
Shaanxi Province Hospital of Traditional Chinese Medicine
Xi'an, Shaanxi, 710003
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, 710068
Yanan University Affiliated Hospital
Yan’an, Shaanxi, 716000
Zhangjiagang Hospital Of Traditional Chinese Medicine
Zhangjiagang, Jiangsu, 215600
About this study
Official title: Post-marketing Safety Surveillance of the Injection of DanShenDuoFenSuanYan (the Injection of Depsides Salts From Salvia Miltiorrhiza): 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.
Read the 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.
- Conditions
- Adverse Drug Reaction
- Keywords
- the Injection of DanShenDuoFenSuanYan, Magnesium Lithospermate B, Safety, Real World Study
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| the Injection of DanShenDuoFenSuanYan | Patient who use the Injection of DanShenDuoFenSuanYan |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of IDSDFSY induced adverse drug reaction
Measured: 3 years
The rare adverse drug reactions to the IDSDFSY
Measured: 3 years
Secondary outcomes (5)
The manifestation, treatment and outcomes of the ADRs
To describe manifestation, treatment and outcomes of the ADRs.
Measured: 3 years
The risk factors of the ADRs
To examine the risk factors of the ADRs.
Measured: 3 years
The patients' characteristics who are prescribed IDSDFSY
To describe the patients' characteristics who are prescribed IDSDFSY.
Measured: 3 years
The prescribing pattern of IDSDFSY in real world clinical practice
To characterize the prescribing pattern of IDSDFSY in real world clinical practice.
Measured: 3 years
Off-label use of IDSDFSY
To describe and evaluate the off-label use of IDSDFSY.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study startJun 2012
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adverse Drug ReactionStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30,180 participants (actual)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Greenvalley Pharmaceutical Co., Ltd., Peking University
- Responsible party
- Principal investigator, Suodi ZHAI, Peking University Third Hospital
- Investigators
- Suodi ZHAI, B.S., Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01872520
- Sponsor's protocol ID
- PekingUTH-Pharmacy-001
- Status last verified
- Oct 2015
- First submitted
- 13 Apr 2013
- Last updated
- 27 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yan YY, Yang YH, Wang WW, Pan YT, Zhan SY, Sun MY, Zhang H, Zhai SD. Post-Marketing Safety Surveillance of the Salvia Miltiorrhiza Depside Salt for Infusion: A Real World Study. PLoS One. 2017 Jan 26;12(1):e0170182. doi: 10.1371/journal.pone.0170182. eCollection 2017.
PubMed 28125608
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Safety Surveillance of the Injection of DanShenDuoFenSuanYan (the Injection of Depsides Salts From Salvia Miltiorrhiza): A Real World Study
- ClinicalTrials.gov ID
- NCT01872520
- Acronym / sponsor ID
- PekingUTH-Pharmacy-001
- Conditions
- Adverse Drug Reaction
- Keywords
- the Injection of DanShenDuoFenSuanYan, Magnesium Lithospermate B, Safety, Real World Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30,180 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Shanghai Greenvalley Pharmaceutical Co., Ltd., Peking University
- Study start
- Jun 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 7 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| the Injection of DanShenDuoFenSuanYan | – | –Patient who use the Injection of DanShenDuoFenSuanYan |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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))
Key inclusion criteria (1 listed)
- 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)).
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The incidence of IDSDFSY induced adverse drug reaction
Time frame: 3 years
The rare adverse drug reactions to the IDSDFSY
Time frame: 3 years
5 secondary outcomes
The manifestation, treatment and outcomes of the ADRs
Time frame: 3 years
The risk factors of the ADRs
Time frame: 3 years
The patients' characteristics who are prescribed IDSDFSY
Time frame: 3 years
The prescribing pattern of IDSDFSY in real world clinical practice
Time frame: 3 years
Off-label use of IDSDFSY
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2015.
- Derived from this study: PubMed 28125608Yan YY, Yang YH, Wang WW, Pan YT, Zhan SY, Sun MY, Zhang H, Zhai SD. Post-Marketing Safety Surveillance of the Salvia Miltiorrhiza Depside Salt for Infusion: A Real World Study. PLoS One. 2017 Jan 26;12(1):e0170182. doi: 10.1371/journal.pone.0170182. eCollection 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suodi ZHAI, B.S. study chair
Peking University Third Hospital
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adverse Drug Reaction, run by Peking University Third Hospital at 36 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of IDSDFSY induced adverse drug reaction (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01872520, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2015.