Safety SurveillanceNCT04479553
Post-marketing Safety Surveillance of Qizhi Tongluo Capsules:a Registry Study.
An observational study of Safety Surveillance and Adverse Drug Events, run by Zhong Wang at 14 sites in China.
Trial summary
This registry aims to monitor the safety of Qizhi Tongluo Capsules and to identify the potential risk factors for its adverse drug reactions. 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?
- Qizhi Tongluo Capsules
- Type of treatment
- Pill or oral medicine
- How many people
- 30,000 participants
- Where
- 14 sitesChina
- Study dates
- 17 Aug 2020to Dec 2023
- How long will I take part?
- 3 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 use Qizhi Tongluo Capsules in the monitoring hospitals.
Who may be able to join
- Patients who use Qizhi Tongluo Capsules in the monitoring hospitals.
Who cannot join
- None
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
China14 sites, 11 recruiting
- Recruiting
Affiliated Hospital of Changzhi Institute of traditional Chinese Medicine
Changzhi, Shanxi, 046000
Jinbin Guo, 13111251707, changzhizynb@126.com
- Recruiting
Ningming County Hospital of Chinese Medicine
Changzuo, Guangxi, 532500
Jie Liu
- Not yet recruiting
Fangchenggang City Hospital of Chinese Medicine
Fangchenggang, Guangxi, 538021
Haizhen Pan
- Recruiting
The Second Affiliated Hospital of Shandong University of Chinese Medicine
Jinan, Shandong, 250001
Xingchen Wang
- Recruiting
Luohe Hospital of traditional Chinese Medicine
Luohe, Henan, 462000
Yingmin Song, 13623957063, sym26567@163.com
- Recruiting
The First Affiliated Hospital of Guangxi University of Chinese Medicine
Nanning, Guangxi, 530023
Peng Wu
- Recruiting
Shanglin County Hospital of Chinese Medicine
Nanning, Guangxi, 530500
Guige Tan
- Recruiting
Long'an County Hospital of Chinese Medicine
Nanning, Guangxi, 532799
Zhenming Lu
- Withdrawn
The First Affiliated Hospital of Nanyang Medical College
Nanyang, Henan, 473000
- Recruiting
The Second Affiliated Hospital of Nanyang Medical College
Nanyang, Henan, 473000
Wanqun Wang
- Not yet recruiting
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, 453199
Ping Zhang, zhangpingsjnk@163.com
- Withdrawn
Affiliated Hospital of Yanbian University
Yanbian, Jilin, 133000
- Not yet recruiting
The First Affiliated Hospital of Henan University of traditional Chinese Medicine
Zhengzhou, Henan, 450003
Xinzhi Wang, 18638189355, znqznq@163.com
- Withdrawn
The Third Affiliated Hospital of Henan University of traditional Chinese Medicine
Zhengzhou, Henan, 450003
About this study
This registry aims to monitor the safety of Qizhi Tongluo Capsules and to identify the potential risk factors for its adverse drug reactions.
- Conditions
- Safety Surveillance, Adverse Drug Events, Adverse Drug Reactions, Severe Adverse Events, Severe Adverse Reactions
- Being tested
- Qizhi Tongluo Capsules
- 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.
Qizhi Tongluo CapsulesDrug
Qizhi Tongluo Capsule, a Chinese patent medicine composed of 26 Chinese herbs, has been approved by China Food and Drug Administration for treating recovery period of ischemic stroke (drug approval numbers: B20171001).
| Study group | Role | What they receive |
|---|---|---|
| Qizhi Tongluo Capsules | Qizhi Tongluo Capsules will be given to the patients, and the investigators will record all the information including ADR, application of Qizhi Tongluo Capsules and the combined medications, etc. Receives: Drug: Qizhi Tongluo Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of adverse drug reactions (ADR) to the Qizhi Tongluo Capsules
Measured: 3 years
Secondary outcomes (6)
The incidence of adverse drug event (ADE) to the Qizhi Tongluo Capsules
Measured: 3 years
The incidence of new ADRs to the Qizhi Tongluo Capsules
Measured: 3 years
The incidence of serious adverse drug event (SADE) to the Qizhi Tongluo Capsules
Measured: 3 years
Changes in biological indicators of patients with serious adverse events
Patients with serious adverse events and suspected unintended serious adverse reactions should be tested for liver function (ALT, AST, ALP, TBIL, DBIL)
Measured: 3 years
Changes in biological indicators of patients with serious adverse events
Patients with serious adverse events and suspected unintended serious adverse reactions should be tested for renal function (BUN, SCr, UA)
Measured: 3 years
Changes in biological indicators of patients with serious adverse events
Patients with serious adverse events and suspected unintended serious adverse reactions should be tested for immune indicators (IgA, IgE, T-lymphocyte, B lymphocyte, cell surface antigen, serum histamine concentration and complement).
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 posted21 Jul 2020
- Study start17 Aug 2020
- Primary completionSep 2023 (estimated)
- Study completionDec 2023 (estimated)
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
- 30,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Zhong Wang
- Sponsor type
- University, hospital or other
- Collaborators
- Shanxi Zhendong Pharmacy Co., Ltd
- Responsible party
- Sponsor-investigator, Zhong Wang, China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04479553
- Sponsor's protocol ID
- QZTL-V1.0
- Status last verified
- Nov 2022
- First submitted
- 17 Jul 2020
- Last updated
- 15 Nov 2022
- 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 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Safety Surveillance of Qizhi Tongluo Capsules:a Registry Study.
- ClinicalTrials.gov ID
- NCT04479553
- Acronym / sponsor ID
- QZTL-V1.0
- Conditions
- Safety Surveillance, Adverse Drug Events, Adverse Drug Reactions, Severe Adverse Events, Severe Adverse Reactions
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- Zhong WangUniversity, hospital or other
- Collaborators
- Shanxi Zhendong Pharmacy Co., Ltd
- Study start
- 17 Aug 2020 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 21 Jul 2020 (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 Qizhi Tongluo Capsules and to identify the potential risk factors for its adverse drug reactions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Qizhi Tongluo Capsules | – | Drug: Qizhi Tongluo CapsulesQizhi Tongluo Capsules will be given to the patients, and the investigators will record all the information including ADR, application of Qizhi Tongluo Capsules 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 Qizhi Tongluo Capsules in the monitoring hospitals.
Key inclusion criteria (1 listed)
- Patients who use Qizhi Tongluo Capsules 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 |
|---|---|---|
| Qizhi Tongluo CapsulesQizhi Tongluo Capsule, a Chinese patent medicine composed of 26 Chinese herbs, has been approved by China Food and Drug Administration for treating recovery period of ischemic stroke (drug approval numbers: B20171001). | Drug | Qizhi Tongluo Capsules |
Primary outcome
The incidence of adverse drug reactions (ADR) to the Qizhi Tongluo Capsules
Time frame: 3 years
6 secondary outcomes
The incidence of adverse drug event (ADE) to the Qizhi Tongluo Capsules
Time frame: 3 years
The incidence of new ADRs to the Qizhi Tongluo Capsules
Time frame: 3 years
The incidence of serious adverse drug event (SADE) to the Qizhi Tongluo Capsules
Time frame: 3 years
Changes in biological indicators of patients with serious adverse events
Time frame: 3 years
Changes in biological indicators of patients with serious adverse events
Time frame: 3 years
Changes in biological indicators of patients with serious adverse events
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
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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.
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 Safety Surveillance and Adverse Drug Events, 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 15 Nov 2022. 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 (86-10-64093207, 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 adverse drug reactions (ADR) to the Qizhi Tongluo Capsules (time frame: 3 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 15 Nov 2022.