Protein; DiseasePhase 1NCT05622877
The Proteomic Study and Early Intervention Study of Carotid Unstable Plaque
A Phase 1 study testing Qushi Formula, Zhu's Wenban Formula and Basic treatment in people with Protein; Disease and Carotid Artery Plaque, run by Guangzhou University of Traditional Chinese Medicine at 1 site in China.
Trial summary
A study on the prediction model of carotid unstable plaque protein and its early intervention. Protein antibody chip was used to detect the remaining biological samples, and patients with carotid artery unstable plaque with stroke risk were selected for interventional clinical trials. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Protein; Disease, Carotid Artery Plaque, Traditional Chinese Medicine
- What is being tested?
- Qushi Formula, Zhu's Wenban Formula and Basic treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 31 May 2023to 31 Dec 2024
- Phase
- Phase 1
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Wet syndrome scale assessment is consistent with wet syndrome diagnosis;
- Carotid color ultrasound indicated carotid artery unstable plaque.
- Protein chip analysis determined that the patients were at high risk of stroke
- Signing informed Consent
Who cannot join
- Carotid artery stenosis rate ≥50%;
- A definite or suspected diagnosis of vasculitis;
- Accompanied by infection, tumor, heart, liver and renal insufficiency (liver and
- kidney function more than twice the upper limit of normal value, cardiac function grade greater than or equal to 2);
- Patients with acute stroke or complicated with acute myocardial infarction and unstable angina pectoris;
- Pregnant or lactating women;
- A prior known allergy to the test drug or the test drug ingredient.
Trial locations and contacts
1 site in 1 country.
China1 site
Guangdong Province Hospital of Tradtional Chinese Medicine
Guangzhou, Guangdong, 510120
About this study
A study on the prediction model of carotid unstable plaque protein and its early intervention. Protein antibody chip was used to detect the remaining biological samples, and patients with carotid artery unstable plaque with stroke risk were selected for interventional clinical trials.
The selected patients were randomly divided into 3 groups, which were treated with Zhu's Wenban Formula (TCM compound granules), Qushi Formula (TCM compound granules) and placebo for 6 months, respectively. The size and number of carotid artery unstable plaques before and after 6 months were observed, and the occurrence of adverse reactions during the intervention period was observed.
- Being tested
- Qushi Formula, Zhu's Wenban Formula, placebo, Basic treatment
- Keywords
- Traditional Chinese Medicine, proteomic study, carotid atherosclerosis plaques
- Medical subject headings
- Disease, Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qushi FormulaDrug
Qushi Formula are decoction granules composed 8 traditional Chinese medicines, such as poria cocos, Macrocephalae Rhizoma, Polyporus, cassia twig, dried ginger and licorice, Etc.
Zhu's Wenban FormulaDrug
Zhu's Wenban granules are decoction granules composed of leech, panax notoginseng, Atractylodes Lancea and rhizome
placeboDrug
The placebo was composed of dextrin, powdered sugar, starch, and liquid caramel in the same color as the other two groups.
Basic treatmentOther
Basic diseases except hyperlipidemia were treated in accordance with the 2014 Chinese Guidelines for Secondary Prevention of Ischemic Stroke/Transient Ischemic Attack. Basic treatment includes conventional treatment such as comprehensive prevention and treatment (actively controlling basic diseases such as hypertension and diabetes and suggesting a good lifestyle), drug therapy (anti-inflammatory, lipid-regulating, anti-platelet aggregation, calcium channel blockers) and so on according to individual conditions of patients.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Group | Placebo comparator | Basic treatment according to the 2014 Chinese Guidelines for Secondary Prevention of Ischemic Stroke/Transient Ischemic Attack and placebo granules (6g/ bag, one bag each time, twice a day after meals); Receives: Drug: placebo; Other: Basic treatment |
| Qushi Formula Group | Experimental | Basic treatment according to the 2014 Chinese Guidelines for Secondary Prevention of Ischemic Stroke/Transient Ischemic Attack and Qushi Formula granules (6g/ bag, one bag each time, twice a day after meals); Receives: Drug: Qushi Formula; Other: Basic treatment |
| Zhu's Wenban Formula Group | Experimental | Basic treatment according to the 2014 Chinese Guidelines for Secondary Prevention of Ischemic Stroke/Transient Ischemic Attack and Zhu's Wenban Formula granules (6g/ bag, one bag each time, twice a day after meals); Receives: Drug: Zhu's Wenban Formula; Other: Basic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in carotid artery unstable plaque
Changes in carotid IMT and the total volume and number of unstable plaques before and after 6 months of treatment
Measured: 6 moths
Secondary outcomes (2)
Changes in blood lipids
The changes of triglyceride, total cholesterol, low density lipoprotein and high density lipoprotein before and after 6 months of treatment;
Measured: 6 moths
Number of new cardiovascular events
Number of cardiovascular and cerebrovascular events during 6 months of treatment and 6 months of follow-up
Measured: 12 moths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start31 May 2023 (estimated)
- Primary completion31 Jan 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Protein; DiseaseStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, jianwen guo, MD, Guangzhou University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05622877
- Sponsor's protocol ID
- SZ2021ZZ3205
- Status last verified
- Mar 2023
- First submitted
- 14 Nov 2022
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Proteomic Study and Early Intervention Study of Carotid Unstable Plaque
- ClinicalTrials.gov ID
- NCT05622877
- Acronym / sponsor ID
- SZ2021ZZ3205
- Keywords
- Traditional Chinese Medicine, proteomic study, carotid atherosclerosis plaques
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Guangzhou University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 31 May 2023 (estimated)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 21 Nov 2022 (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.
A study on the prediction model of carotid unstable plaque protein and its early intervention. Protein antibody chip was used to detect the remaining biological samples, and patients with carotid artery unstable plaque with stroke risk were selected for interventional clinical trials.
The selected patients were randomly divided into 3 groups, which were treated with Zhu's Wenban Formula (TCM compound granules), Qushi Formula (TCM compound granules) and placebo for 6 months, respectively. The size and number of carotid artery unstable plaques before and after 6 months were observed, and the occurrence of adverse reactions during the intervention period was observed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo Group | Placebo comparator | Drug: placebo, Other: Basic treatmentBasic treatment according to the 2014 Chinese Guidelines for Secondary Prevention of Ischemic Stroke/Transient Ischemic Attack and placebo granules (6g/ bag, one bag each time, twice a day after meals); |
| Qushi Formula Group | Experimental | Drug: Qushi Formula, Other: Basic treatmentBasic treatment according to the 2014 Chinese Guidelines for Secondary Prevention of Ischemic Stroke/Transient Ischemic Attack and Qushi Formula granules (6g/ bag, one bag each time, twice a day after meals); |
| Zhu's Wenban Formula Group | Experimental | Drug: Zhu's Wenban Formula, Other: Basic treatmentBasic treatment according to the 2014 Chinese Guidelines for Secondary Prevention of Ischemic Stroke/Transient Ischemic Attack and Zhu's Wenban Formula granules (6g/ bag, one bag each time, twice a day after meals); |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Wet syndrome scale assessment is consistent with wet syndrome diagnosis;
- Carotid color ultrasound indicated carotid artery unstable plaque.
- Protein chip analysis determined that the patients were at high risk of stroke
- Signing informed Consent
Key exclusion criteria (7 listed)
- Carotid artery stenosis rate ≥50%;
- A definite or suspected diagnosis of vasculitis;
- Accompanied by infection, tumor, heart, liver and renal insufficiency (liver and
- kidney function more than twice the upper limit of normal value, cardiac function grade greater than or equal to 2);
- Patients with acute stroke or complicated with acute myocardial infarction and unstable angina pectoris;
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 |
|---|---|---|
| Qushi FormulaQushi Formula are decoction granules composed 8 traditional Chinese medicines, such as poria cocos, Macrocephalae Rhizoma, Polyporus, cassia twig, dried ginger and licorice, Etc. | Drug | Qushi Formula Group |
| Zhu's Wenban FormulaZhu's Wenban granules are decoction granules composed of leech, panax notoginseng, Atractylodes Lancea and rhizome | Drug | Zhu's Wenban Formula Group |
| placeboThe placebo was composed of dextrin, powdered sugar, starch, and liquid caramel in the same color as the other two groups. | Drug | Placebo Group |
| Basic treatmentBasic diseases except hyperlipidemia were treated in accordance with the 2014 Chinese Guidelines for Secondary Prevention of Ischemic Stroke/Transient Ischemic Attack. Basic treatment includes conventional treatment such as comprehensive prevention and treatment (actively controlling basic diseases such as hypertension and diabetes and suggesting a good lifestyle), drug therapy (anti-inflammatory, lipid-regulating, anti-platelet aggregation, calcium channel blockers) and so on according to individual conditions of patients. | Other | Placebo Group, Qushi Formula Group, Zhu's Wenban Formula Group |
Primary outcome
Changes in carotid artery unstable plaque
Time frame: 6 moths
Changes in carotid IMT and the total volume and number of unstable plaques before and after 6 months of treatment
2 secondary outcomes
Changes in blood lipids
Time frame: 6 moths
Number of new cardiovascular events
Time frame: 12 moths
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Qushi Formula, Zhu's Wenban Formula and Basic treatment in people with Protein; Disease and Carotid Artery Plaque, run by Guangzhou University of Traditional Chinese Medicine at 1 site 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 4 inclusion and 7 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 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Changes in carotid artery unstable plaque (time frame: 6 moths). 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 14 Mar 2023.