Adverse Drug EventNCT03640884
Post-marketing Safety Surveillance of Xueshuantong-Injection : a Registry Study
An observational study of Adverse Drug Event and Adverse Drug Reactions, run by Zhong Wang at 14 sites in China.
Trial summary
This registry aims to monitor the safety of Xueshuantong 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 Reactions, Anaphylactic Reaction
- What is being tested?
- Xueshuantong-Injection
- Type of treatment
- Injection or infusion
- How many people
- 30,000 participants
- Where
- 14 sitesChina
- Study dates
- 18 Feb 2019to Jun 2022
- How long will I take part?
- 2 Years
- 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 received the Xueshuantong-Injection for treatment will be consecutive included in this registry
Who may be able to join
- Patients who use Xueshuantong-Injection in the monitoring departments of certain hospitals
Who cannot join
- None
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
China14 sites, 14 recruiting
- Recruiting
Chinse Medical Hospital of Yangxin County
Binzhou, Shandong, 251800
Bingyi Qin, 86-15206898878
Bingyi Qin
- Recruiting
Central Hospital of Wafangdian City
Dalian, Liaoning, 116300
Qiang Zhao, 86-15542661833, ywk85603813@163.com
Qiang Zhao
- Recruiting
Jizhou City Hospital
Hengshui, Hebei, 053200
Zhuci Li, 86-13785829166
Zhuci Li
- Recruiting
Yangcheng County People's Hospital
Jincheng, Shanxi, 048100
Wangtai Cheng, 86-13934060268
Wangtai Cheng
- Recruiting
Lingshi Country People's Hospital
Jinzhong, Shanxi, 031300
Xiaoqin Wu, 86-13834185284
Xiaoqin Wu
- Recruiting
Donghai Country People's Hospital
Lianyungang, Jiangsu, 222300
Liangliang Xia, 86-15961321388
Liangliang Xia
- Recruiting
Lingyuan City Central Hospital
Lingyuan, Liaoning, 222500
Shuying Bai, 86-13842101618
Shuying Bai
- Recruiting
Tongbai County People's Hospital
Nanyang, Henan, 474750
Yuqian Liu, 86-13849716243
Yuqian Liu
- Recruiting
Lingbao 3th People's Hospital
Sanmenxia, Henan, 472500
Wenhui Li, 86-13569601991
Wenhui Li
- Recruiting
Weihai Wendeng District People's Hospital
Weihai, Shandong, 264422
Jinguo Zhao, 86-13561852177
Jinguo Zhao
- Recruiting
Dongxihu District People's Hospital
Wuhan, Hubei, 430040
Hanqiao Wang, 86-13707141018
Hanqiao Wang
- Recruiting
People's Hospital of Yichun City
Yichun, Jiangxi, 362201
Huilin Leng, 86-13870538072
Huilin Leng
- Recruiting
Shanxi Yuanping First People's Hospital
Yuanping, Shanxi, 034100
Yutian Zhang, 86-13994126666
Yutian Zhang
- Recruiting
People's Hospital of Dancheng County
Zhoukou, Henan, 477150
Yuwang Yang, 86-13333943936
Yuwang Yang
About this study
This registry aims to monitor the safety of Xueshuantong Injection and to identify the potential risk factors for the adverse drug reactions.
Read the detailed description
Xueshuantong-Injection is a kind of natural compound injection with Panax notoginseng saponins(PNS). It's a popular drug for improving blood circulation that focusing on central retinal vein occlusion, stroke sequela, internal ophthalmopathy, hyphema and so on. However, more and more case reports about the adverse drug events of Panax notoginseng saponins have been reported in recent years. Therefore, this registry of Xueshuantong-Injection aims to monitor the safety and find the incidence of adverse drug reactions to Xueshuantong-Injection. Moreover, this registry is highly concerned on identifying the potential risk factors for the adverse drug reactions.
- Conditions
- Adverse Drug Event, Adverse Drug Reactions, Anaphylactic Reaction, Severe Adverse Reactions
- Being tested
- Xueshuantong-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.
Xueshuantong-InjectionDrug
Also called Chenzhong
Xueshuantong-Injection is a kind of natural compound injection extracted from Chinese herb Notoginseng. The major bioactive ingredient is panax notoginseng saponins.
| Study group | Role | What they receive |
|---|---|---|
| Xueshuantong-Injection | Patients who received the Xueshuantong-Injection for treatment will be consecutive included in this registry. The investigators will record all the information about ADR, application of Xueshuantong-Injection and the combined medications, etc. Receives: Drug: Xueshuantong-Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of severe adverse reactions (SAR) of Xueshuantong-Injection
A serious adverse reactions (SAR) is any untoward medical occurrence suspected to be medicinal product-related that at any dose: Results in death, is life-threatening, NOTE: The term "life-threatening" in the definition of "serious" refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe. Requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or Is a congenital anomaly/birth defect.
Measured: 2 years
Secondary outcomes (6)
The incidence of adverse drug reactions (ADR) of Xueshuantong-Injection
Measured: 2 years
The incidence of adverse events （AE）of Xueshuantong-Injection
Measured: 2 years
The incidence of serious adverse events （SAE）of Xueshuantong-Injection
Measured: 2 years
The incidence of anaphylactic reaction of Xueshuantong-Injection
Measured: 2 years
The incidence of new ADRs of Xueshuantong-Injection
Measured: 2 years
The effective rate of Xueshuantong-Injection
The proportion of the patients whose drug effect is considered as "effective" by investigator
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start18 Feb 2019
- Primary completionDec 2021 (estimated)
- Study completionJun 2022 (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
- 30,000 participants (estimated)
- Target duration
- 2 Years
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, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical SciencesJinmin Liu, M.D., Principal investigator, Dongfang Hospital Affiliated to Beijing University of traditional Chinese medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03640884
- Sponsor's protocol ID
- Xueshuantong--V2.0
- Status last verified
- Jul 2021
- First submitted
- 17 Aug 2018
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Safety Surveillance of Xueshuantong-Injection : a Registry Study
- ClinicalTrials.gov ID
- NCT03640884
- Acronym / sponsor ID
- Xueshuantong--V2.0
- Conditions
- Adverse Drug Event, Adverse Drug Reactions, Anaphylactic Reaction, Severe Adverse Reactions
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- Zhong WangUniversity, hospital or other
- Study start
- 18 Feb 2019 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 21 Aug 2018 (actual)
- 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 Xueshuantong Injection and to identify the potential risk factors for the adverse drug reactions.
Detailed description
Xueshuantong-Injection is a kind of natural compound injection with Panax notoginseng saponins(PNS). It's a popular drug for improving blood circulation that focusing on central retinal vein occlusion, stroke sequela, internal ophthalmopathy, hyphema and so on. However, more and more case reports about the adverse drug events of Panax notoginseng saponins have been reported in recent years. Therefore, this registry of Xueshuantong-Injection aims to monitor the safety and find the incidence of adverse drug reactions to Xueshuantong-Injection. Moreover, this registry is highly concerned on identifying the potential risk factors for the adverse drug reactions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Xueshuantong-Injection | – | Drug: Xueshuantong-InjectionPatients who received the Xueshuantong-Injection for treatment will be consecutive included in this registry. The investigators will record all the information about ADR, application of Xueshuantong-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 received the Xueshuantong-Injection for treatment will be consecutive included in this registry
Key inclusion criteria (1 listed)
- Patients who use Xueshuantong-Injection in the monitoring departments of certain 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 |
|---|---|---|
| Xueshuantong-InjectionAlso: ChenzhongXueshuantong-Injection is a kind of natural compound injection extracted from Chinese herb Notoginseng. The major bioactive ingredient is panax notoginseng saponins. | Drug | Xueshuantong-Injection |
Primary outcome
The incidence of severe adverse reactions (SAR) of Xueshuantong-Injection
Time frame: 2 years
A serious adverse reactions (SAR) is any untoward medical occurrence suspected to be medicinal product-related that at any dose: Results in death, is life-threatening, NOTE: The term "life-threatening" in the definition of "serious" refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe. Requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or Is a congenital anomaly/birth defect.
6 secondary outcomes
The incidence of adverse drug reactions (ADR) of Xueshuantong-Injection
Time frame: 2 years
The incidence of adverse events （AE）of Xueshuantong-Injection
Time frame: 2 years
The incidence of serious adverse events （SAE）of Xueshuantong-Injection
Time frame: 2 years
The incidence of anaphylactic reaction of Xueshuantong-Injection
Time frame: 2 years
The incidence of new ADRs of Xueshuantong-Injection
Time frame: 2 years
The effective rate of Xueshuantong-Injection
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 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
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
Jinmin Liu, M.D. principal investigator
Dongfang Hospital Affiliated to Beijing University of traditional Chinese medicine
14 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 Reactions, run by Zhong Wang at 14 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: status not confirmed, as of the sponsor's last update on 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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?
Contact Zhong Wang, M.D. (8610-64093140, zhonw@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of severe adverse reactions (SAR) of Xueshuantong-Injection (time frame: 2 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 7 Jul 2021.