Adverse Drug EventNCT02559960
Post-marketing Safety Surveillance of Breviscapine Powder-Injection : a Registry Study
An observational study of Adverse Drug Event and Adverse Drug Reaction, run by Zhong Wang at 15 sites in China.
Trial summary
This registry aims to monitor the safety of Breviscapine Powder-Injection and to identify the potential risk factors for the adverse drug reactions. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Adverse Drug Event, Adverse Drug Reaction, Chinese Medicine
- What is being tested?
- Breviscapine Powder-Injection
- Type of treatment
- Injection or infusion
- How many people
- 20,000 participants
- Where
- 15 sitesChina
- Study dates
- Sep 2015to Dec 2021
- 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 Breviscapine Powder-Injection in the monitoring departments of centain hospitals
Who may be able to join
- Patients who use Breviscapine Powder-Injection in the monitoring departments of centain hospitals
Who cannot join
- None
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
China15 sites
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
The People's Hospital of Zuanjiang District, Chongqing City
Chongqing, Chongqing Municipality, 401420
People's Hospital of Jun County
Hebi, Henan, 456250
The Red Cross Hosptal of Yunnan
Kunming, Yunnan, 650021
First Affilicated Hospital of Kunming Medical University
Kunming, Yunnan, 650032
Mudanjiang City Second People's Hospital
Mudanjiang, Heilongjiang, 157013
Shanxi Provincial Hospital of Traditional Chinese Medicine
Taiyuan, Shanxi, 030012
Changzheng Hospital of Tianjin City
Tianjin, Tianjin Municipality, 300021
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
People's Hospital of Changge City
Xuchang, Henan, 461599
Zaozhuang Hospital of T.C.M
Zaozhuang, Shandong, 277000
Shandong Energy Zaozhuang Mining Group Center Hospital
Zaozhuang, Shandong, 277800
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450014
Zhengzhou Second Hospital
Zhengzhou, Henan, 450015
The First Hospital of Henan College of Traditional Chinese Medicine
Zhengzhou, Henan, 451199
About this study
This registry aims to monitor the safety of Breviscapine Powder-Injection and to identify the potential risk factors for the adverse drug reactions.
Read the detailed description
Breviscapine Powder-Injection is a kind of natural compound injection with high purity of Scutellarin-Na (over 98%). It's a popular drug for ischemic diseases, as cerebral ischemic stroke, coronary heart disease or angor pectoris. However, more and more case reports about the adverse drug events of Chinese medicine injections extracted from Dengzhanhua (herba erigernotis) (Breviscapine is one of the most common compounds in it) have been reported in recent 10 years. Therefore, this registry of Breviscapine Powder-Injection aims to monitor the safety of Breviscapine Powder-Injection and to identify the potential risk factors for the adverse drug reactions.
- Being tested
- Breviscapine Powder-Injection
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions, Anaphylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breviscapine Powder-InjectionDrug
Also called Zhusheyong Deng-zhan-hua-su
Patients will be given Breviscapine Powder-Injection according to their disease condition in the real world. The investigator only can record the information on the usage of the drug and the relevant medications without any interventions.
| Study group | Role | What they receive |
|---|---|---|
| Breviscapine Powder-Injection | Breviscapine Powder-Injection will be given to the patients, and the investigators will record all the information including ADR, application of Breviscapine Powder-Injection and the combined medications, etc. Receives: Drug: Breviscapine Powder-Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of anaphylactic reaction to Breviscapine Powder-Injection
Measured: 1 years
Secondary outcomes (6)
The incidence of severe adverse events (SAEs) to Breviscapine Powder-Injection
Measured: 1 years
The incidence of new SAEs to Breviscapine Powder-Injection
Measured: 1 years
The incidence of adverse drug events (ADEs) to Breviscapine Powder-Injection
Measured: 1 years
The incidence of new ADEs to Breviscapine Powder-Injection
Measured: 1 years
The effective rate of Breviscapine Powder-Injection
The proportion of the patients whose drug effect is considered as "effective" by investigator.
Measured: 1 years
The patient satisfaction rate for the therapy of Breviscapine Powder-Injection
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionAug 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse Drug EventStudies of the same condition, open and under way.
- 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
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhong Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhong Wang, China Academy of Chinese Medical Sciences
- Investigators
- Zhong Wang, M.D., Study director, China Academy of Chinese Medical SciencesXin-zhi Wang, Principal investigator, The First Hospital of Henan College of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02559960
- Sponsor's protocol ID
- Dengzhan-V1.0
- Status last verified
- Apr 2021
- First submitted
- 24 Sep 2015
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Safety Surveillance of Breviscapine Powder-Injection : a Registry Study
- ClinicalTrials.gov ID
- NCT02559960
- Acronym / sponsor ID
- Dengzhan-V1.0
- Study type
- Observational
- Recruitment status
- Suspended
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Zhong WangUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 25 Sep 2015 (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.
This registry aims to monitor the safety of Breviscapine Powder-Injection and to identify the potential risk factors for the adverse drug reactions.
Detailed description
Breviscapine Powder-Injection is a kind of natural compound injection with high purity of Scutellarin-Na (over 98%). It's a popular drug for ischemic diseases, as cerebral ischemic stroke, coronary heart disease or angor pectoris. However, more and more case reports about the adverse drug events of Chinese medicine injections extracted from Dengzhanhua (herba erigernotis) (Breviscapine is one of the most common compounds in it) have been reported in recent 10 years. Therefore, this registry of Breviscapine Powder-Injection aims to monitor the safety of Breviscapine Powder-Injection and to identify the potential risk factors for the adverse drug reactions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breviscapine Powder-Injection | – | Drug: Breviscapine Powder-InjectionBreviscapine Powder-Injection will be given to the patients, and the investigators will record all the information including ADR, application of Breviscapine Powder-Injection and the combined medications, etc. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who use Breviscapine Powder-Injection in the monitoring departments of centain hospitals
Key inclusion criteria (1 listed)
- Patients who use Breviscapine Powder-Injection in the monitoring departments of centain hospitals
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breviscapine Powder-InjectionAlso: Zhusheyong Deng-zhan-hua-suPatients will be given Breviscapine Powder-Injection according to their disease condition in the real world. The investigator only can record the information on the usage of the drug and the relevant medications without any interventions. | Drug | Breviscapine Powder-Injection |
Primary outcome
The incidence of anaphylactic reaction to Breviscapine Powder-Injection
Time frame: 1 years
6 secondary outcomes
The incidence of severe adverse events (SAEs) to Breviscapine Powder-Injection
Time frame: 1 years
The incidence of new SAEs to Breviscapine Powder-Injection
Time frame: 1 years
The incidence of adverse drug events (ADEs) to Breviscapine Powder-Injection
Time frame: 1 years
The incidence of new ADEs to Breviscapine Powder-Injection
Time frame: 1 years
The effective rate of Breviscapine Powder-Injection
Time frame: 1 years
The patient satisfaction rate for the therapy of Breviscapine Powder-Injection
Time frame: 1 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
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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.
Zhong Wang, M.D. study director
China Academy of Chinese Medical Sciences
Xin-zhi Wang principal investigator
The First Hospital of Henan College of Traditional Chinese Medicine
15 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 Event and Adverse Drug Reaction, run by Zhong Wang at 15 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: paused, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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?
Results are not available in the source record.
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 anaphylactic reaction to Breviscapine Powder-Injection (time frame: 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2021.