Carotid Artery PlaquePhase 2SpchimNCT03072225
Study on Vulnerable Plaque of Carotid Artery With Chinese Herbal and Insects Medicine
A Phase 2 study testing Herbal Medicine C-117 in people with Carotid Artery Plaque, run by Guangzhou University of Traditional Chinese Medicine.
Trial summary
The investigators want treat Vulnerable plaque of carotid artery with a herbal and insects Chinese medicine. Designing a RCT trial to prove the effect and safety. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Plaque
- What is being tested?
- Herbal Medicine C-117
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Mar 2017to Dec 2018
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet the diagnostic criteria of carotid artery atherosclerosis;
- Ultrasound of carotid artery atherosclerosis plaque specifies it as unstable plaque (including malacoplakia and mixed plaque);
Who cannot join
- mRS Rating higher than or equal to 3 before joining the trail group;
- Carotid artery stenosis is higher than or equal to 50%;
- Confirmed as or suspected to be vasculitis;
- With infection, tumor or insufficient heart, liver and kidney functions (renal function higher than twice of upper limit in normal limit, HYHA heart function grading higher than or equal to level 2 );
- With acute myocardial infarction and unstable angina pectoris;
- With acute cerebral arterial thrombosis;
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- lesion: Severe stenosis or occlusion of distal intracranial vessels;
- Pregnant women or lactating mothers;
- With known history of allergy to the drugs of the trial.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Randomized Controlled Clinical Study on Vulnerable Plaque of Carotid Artery With Chinese Herbal and Insects Medicine
The investigators want treat Vulnerable plaque of carotid artery with a herbal and insects Chinese medicine. Designing a RCT trial to prove the effect and safety.
Read the detailed description
Vulnerable plaque of carotid artery is the important intervention target for primary prevention and secondary prevention of cerebral arterial thrombosis, but there are no effective, safe and prevalent treatment measures against it. The development that traditional Chinese medicine has achieved in treating plaque of carotid artery shows that great accomplishment could be made within this area. Academia should engage in clinical research on regulated treatment methods in traditional Chinese medicine with long-term intervention and high patient compliance, providing strong evidence for evidence-based medicine and guidance to clinical practice.
- Conditions
- Carotid Artery Plaque
- Being tested
- Herbal Medicine C-117, The Placebo of Herbal Medicine C-117
- Keywords
- herbal medicine, stroke, vulnerable plaques of carotid artery
- Medical subject headings
- Carotid Stenosis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Herbal Medicine C-117Drug
Herbal Medicine C-117 formula including 2 herbals and 2 insects
The Placebo of Herbal Medicine C-117Drug
The Placebo of Herbal Medicine C-117 formula including 4 herbals
| Study group | Role | What they receive |
|---|---|---|
| Herbal Medicine C-117 | Experimental | Herbal Medicine C-117 Prescription (6g/bag，one bag each time, twice a day.) for 6 months Receives: Drug: Herbal Medicine C-117 |
| The Placebo of Herbal Medicine C-117 | Placebo comparator | Placebo of Herbal Medicine C-117 (6g/bag，one bag each time, twice a day.) for 6 months Receives: Drug: The Placebo of Herbal Medicine C-117 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total number of all-cause mortality and all-cause stroke within 12 months
After drug-use 6 months, observe all-cause mortality and all-cause stroke (hemorrhage or ischemic).
Measured: 1 years
Secondary outcomes (3)
The nature of Vulnerable plaque of carotid artery through color ultrasound
At the time of 6 months, observe the nature of Vulnerable plaque of carotid artery through color ultrasound, comparing with the result before using drugs
Measured: 6 months
The number of Vulnerable plaque of carotid artery through color ultrasound
At the time of 6 months, observe the nature of Vulnerable plaque of carotid artery through color ultrasound, comparing with the result before using
Measured: 6 months
Blood lipid levels
At the time of 6 months, the investigators will observe the blood lipid levels
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2017
- Study startMar 2017 (estimated)
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carotid Artery PlaqueStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianwen Guo, MD, Principal investigator, Guangdong Province Hospital of Tradtional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03072225
- Sponsor's protocol ID
- YN2014LN08
- Acronym
- Spchim
- Status last verified
- Feb 2017
- First submitted
- 18 Feb 2017
- Last updated
- 7 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gong B, Chen X, Lin R, Zhang F, Zhong J, Zhang Q, Zhou Y, Li H, Zeng L, Jiang Z, Guo J. Safety and Efficacy of the C-117 Formula for Vulnerable Carotid Artery Plaques (Spchim): A Randomized Double-Blind Controlled Pilot Study. Evid Based Complement Alternat Med. 2019 Jul 17;2019:9746492. doi: 10.1155/2019/9746492. eCollection 2019.
PubMed 31391862
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Clinical Study on Vulnerable Plaque of Carotid Artery With Chinese Herbal and Insects Medicine
- ClinicalTrials.gov ID
- NCT03072225
- Acronym / sponsor ID
- Spchim / YN2014LN08
- Conditions
- Carotid Artery Plaque
- Keywords
- herbal medicine, stroke, vulnerable plaques of carotid artery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Guangzhou University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Mar 2017 (estimated)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 7 Mar 2017 (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.
The investigators want treat Vulnerable plaque of carotid artery with a herbal and insects Chinese medicine. Designing a RCT trial to prove the effect and safety.
Detailed description
Vulnerable plaque of carotid artery is the important intervention target for primary prevention and secondary prevention of cerebral arterial thrombosis, but there are no effective, safe and prevalent treatment measures against it. The development that traditional Chinese medicine has achieved in treating plaque of carotid artery shows that great accomplishment could be made within this area. Academia should engage in clinical research on regulated treatment methods in traditional Chinese medicine with long-term intervention and high patient compliance, providing strong evidence for evidence-based medicine and guidance to clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Herbal Medicine C-117 | Experimental | Drug: Herbal Medicine C-117Herbal Medicine C-117 Prescription (6g/bag，one bag each time, twice a day.) for 6 months |
| The Placebo of Herbal Medicine C-117 | Placebo comparator | Drug: The Placebo of Herbal Medicine C-117Placebo of Herbal Medicine C-117 (6g/bag，one bag each time, twice a day.) for 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Meet the diagnostic criteria of carotid artery atherosclerosis;
- Ultrasound of carotid artery atherosclerosis plaque specifies it as unstable plaque (including malacoplakia and mixed plaque);
Key exclusion criteria (9 listed)
- mRS Rating higher than or equal to 3 before joining the trail group;
- Carotid artery stenosis is higher than or equal to 50%;
- Confirmed as or suspected to be vasculitis;
- With infection, tumor or insufficient heart, liver and kidney functions (renal function higher than twice of upper limit in normal limit, HYHA heart function grading higher than or equal to level 2 );
- 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 |
|---|---|---|
| Herbal Medicine C-117Herbal Medicine C-117 formula including 2 herbals and 2 insects | Drug | Herbal Medicine C-117 |
| The Placebo of Herbal Medicine C-117The Placebo of Herbal Medicine C-117 formula including 4 herbals | Drug | The Placebo of Herbal Medicine C-117 |
Primary outcome
The total number of all-cause mortality and all-cause stroke within 12 months
Time frame: 1 years
After drug-use 6 months, observe all-cause mortality and all-cause stroke (hemorrhage or ischemic).
3 secondary outcomes
The nature of Vulnerable plaque of carotid artery through color ultrasound
Time frame: 6 months
The number of Vulnerable plaque of carotid artery through color ultrasound
Time frame: 6 months
Blood lipid levels
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2017.
- Derived from this study: PubMed 31391862Gong B, Chen X, Lin R, Zhang F, Zhong J, Zhang Q, Zhou Y, Li H, Zeng L, Jiang Z, Guo J. Safety and Efficacy of the C-117 Formula for Vulnerable Carotid Artery Plaques (Spchim): A Randomized Double-Blind Controlled Pilot Study. Evid Based Complement Alternat Med. 2019 Jul 17;2019:9746492. doi: 10.1155/2019/9746492. eCollection 2019.
- Individual participant dataSharing planned: No
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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.
Jianwen Guo, MD principal investigator
Guangdong Province Hospital of Tradtional Chinese Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Herbal Medicine C-117 in people with Carotid Artery Plaque, run by Guangzhou University of Traditional Chinese Medicine.
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 2 inclusion and 9 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 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Jianwen Guo, Bachelor (020-81887233, jianwen_guo@msn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The total number of all-cause mortality and all-cause stroke within 12 months (time frame: 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03072225, which also lists 1 linked publication.
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 Mar 2017.