Safety SurveillanceNCT02239237
Post-marketing Safety Surveillance of Compound Kuh-seng Injection: a Registry Study
An observational study of Safety Surveillance and Adverse Drug Events, run by Zhong Wang at 29 sites in China.
Trial summary
This registry aims to monitor the safety of Compound Kuh-seng Injection and to identify the potential risk factors for the adverse drug reactions. Compound Kuh-seng Injection is a kind of natural compound injection extracted from herbs Kuh-seng (Radix Sophorae Flavescentis) and Rhizoma Heterosmilacis Japonicae. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Safety Surveillance, Adverse Drug Events, Adverse Drug Reactions
- What is being tested?
- Compound Kuh-seng Injection
- Type of treatment
- Injection or infusion
- How many people
- 30,283 participants
- Where
- 29 sitesChina
- Study dates
- Sep 2014to Oct 2018
- 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 Compound Kushen Injection in the monitoring hospitals
Who may be able to join
- Patients who use Compound Kushen Injection in the monitoring hospitals
Who cannot join
- None
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
China29 sites
Chengdu Second People's Hospital
Chengdu, Sichuan, 610017
AVIC 363 Hospital
Chengdu, Sichuan, 610041
Teaching Hospital of Chengdu University of T.C.M.
Chengdu, Sichuan, 610072
HanDan Central Hospital
Handan, Hebei, 056001
Handan First Hospital
Handan, Hebei, 056002
Shandong Provincial Western Hospital
Jinan, Shandong, 250022
Jincheng General Hospital
Jincheng, Shanxi, 048006
Henan University Huaihe Hospital
Kaifeng, Henan, 475001
The Fourth People's Hospital of Linfen
Linfen, Shanxi, 041099
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, 471000
Luoyang Central Hospital Affiliated to Zhengzhou University
Luoyang, Henan, 471009
Qingdao Center Hospital
Qingdao, Shandong, 266031
Bai Qiu'en International Peace Hospital
Shijiazhuang, Hebei, 050082
Tai'an Central Hospital
Tai’an, Shandong, 271000
The 88th Hospital of People's Liberation Army
Tai’an, Shandong, 271002
People's Hospital of Xintai City
Tai’an, Shandong, 271200
Traditional Chinese Hospital of Shanxi
Taiyuan, Shanxi, 030012
Tianjin medical university cancer institute & hosptial
Tianjin, Tianjin Municipality, 300060
Weifang No.2 People's Hospital
Weifang, Shandong, 261041
Weihai Municipal Hospital
Weihai, Shandong, 264299
Xinxiang Central Hospital
Xinxiang, Henan, 453000
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, 453199
Xinyang Central Hospital
Xinyang, Henan, 464000
The Second People's Hospital of Yibin
Yibin, Sichuan, 644000
Yuncheng Central Hospital
Yuncheng, Shanxi, 044099
People's Hospital of Zhengzhou
Zhengzhou, Henan, 450003
Henan Cancer Hospital
Zhengzhou, Henan, 450008
The First Hospital of Henan College of Traditional Chinese Medicine
Zhengzhou, Henan, 451199
Central Hospital of Zibo
Zibo, Shandong, 255020
About this study
This registry aims to monitor the safety of Compound Kuh-seng Injection and to identify the potential risk factors for the adverse drug reactions. Compound Kuh-seng Injection is a kind of natural compound injection extracted from herbs Kuh-seng (Radix Sophorae Flavescentis) and Rhizoma Heterosmilacis Japonicae.
- Conditions
- Safety Surveillance, Adverse Drug Events, Adverse Drug Reactions, Severe Adverse Events, Severe Adverse Reactions
- Being tested
- Compound Kuh-seng Injection
- 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.
Compound Kuh-seng InjectionDrug
Also called Compound Kushen Injection, Fufang Kushen Zhusheye
Compound Kuh-seng Injection is a kind of natural compound injection extracted from Chinese herbs Kuh-seng (Radix Sophorae Flavescentis) and Rhizoma Heterosmilacis Japonicae. The major bioactive ingredients include oxymatrine，sophocarpidine, matrine, flavonoid etc.
| Study group | Role | What they receive |
|---|---|---|
| Compound Kuh-seng Injection | Compound Kuh-seng Injection will be given to the patients, and the investigators will record all the information including ADR, application of Compound Kuh-seng Injection and the combined medications, etc. Receives: Drug: Compound Kuh-seng 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) to the Compound Kuh-seng Injection
Measured: 2 years
Secondary outcomes (4)
The incidence of adverse drug reactions (ADR) to Compound Kuh-seng Injection
Measured: 2 years
The incidence of anaphylactic reaction to Compound Kuh-seng Injection
Measured: 2 years
The incidence of new ADRs to Compound Kuh-seng Injection
Measured: 2 years
The incidence of new SARs to Compound Kuh-seng Injection
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 posted12 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionJun 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety SurveillanceStudies 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
- 30,283 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhong Wang
- Sponsor type
- University, hospital or other
- Collaborators
- Shanxi Zhendong pharmaceutical Co. LTD.
- 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 SciencesZhan-Yu Pan, Ph.D., Principal investigator, Tianjin medical university cancer institute & hosptial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02239237
- Sponsor's protocol ID
- Kuh-seng1.0
- Status last verified
- Oct 2018
- First submitted
- 10 Sep 2014
- Last updated
- 10 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Safety Surveillance of Compound Kuh-seng Injection: a Registry Study
- ClinicalTrials.gov ID
- NCT02239237
- Acronym / sponsor ID
- Kuh-seng1.0
- Conditions
- Safety Surveillance, Adverse Drug Events, Adverse Drug Reactions, Severe Adverse Events, Severe Adverse Reactions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30,283 participants (actual)
- Lead sponsor
- Zhong WangUniversity, hospital or other
- Collaborators
- Shanxi Zhendong pharmaceutical Co. LTD.
- Study start
- Sep 2014 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 12 Sep 2014 (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 Compound Kuh-seng Injection and to identify the potential risk factors for the adverse drug reactions. Compound Kuh-seng Injection is a kind of natural compound injection extracted from herbs Kuh-seng (Radix Sophorae Flavescentis) and Rhizoma Heterosmilacis Japonicae.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Compound Kuh-seng Injection | – | Drug: Compound Kuh-seng InjectionCompound Kuh-seng Injection will be given to the patients, and the investigators will record all the information including ADR, application of Compound Kuh-seng 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 Compound Kushen Injection in the monitoring hospitals
Key inclusion criteria (1 listed)
- Patients who use Compound Kushen Injection in the monitoring 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 |
|---|---|---|
| Compound Kuh-seng InjectionAlso: Compound Kushen Injection, Fufang Kushen ZhusheyeCompound Kuh-seng Injection is a kind of natural compound injection extracted from Chinese herbs Kuh-seng (Radix Sophorae Flavescentis) and Rhizoma Heterosmilacis Japonicae. The major bioactive ingredients include oxymatrine，sophocarpidine, matrine, flavonoid etc. | Drug | Compound Kuh-seng Injection |
Primary outcome
The incidence of severe adverse reactions (SAR) to the Compound Kuh-seng Injection
Time frame: 2 years
4 secondary outcomes
The incidence of adverse drug reactions (ADR) to Compound Kuh-seng Injection
Time frame: 2 years
The incidence of anaphylactic reaction to Compound Kuh-seng Injection
Time frame: 2 years
The incidence of new ADRs to Compound Kuh-seng Injection
Time frame: 2 years
The incidence of new SARs to Compound Kuh-seng Injection
Time frame: 2 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 10 Oct 2018.
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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
Zhan-Yu Pan, Ph.D. principal investigator
Tianjin medical university cancer institute & hosptial
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Safety Surveillance and Adverse Drug Events, run by Zhong Wang at 29 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 10 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 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 severe adverse reactions (SAR) to the Compound Kuh-seng 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 10 Oct 2018.