Clinical trial NCT03072225: Study on Vulnerable Plaque of Carotid Artery With Chinese Herbal and Insects Medicine
Official title: Randomized Controlled Clinical Study on Vulnerable Plaque of Carotid Artery With Chinese Herbal and Insects Medicine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Carotid Artery Plaque
Keywords: herbal medicine
stroke
vulnerable plaques of carotid artery
Lead sponsor: Guangzhou University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2017-03-07
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Meet the diagnostic criteria of carotid artery atherosclerosis;
2. Ultrasound of carotid artery atherosclerosis plaque specifies it as unstable plaque (including malacoplakia and mixed plaque);

Exclusion Criteria:

1. mRS Rating higher than or equal to 3 before joining the trail group;
2. Carotid artery stenosis is higher than or equal to 50%;
3. Confirmed as or suspected to be vasculitis;
4. 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 );
5. With acute myocardial infarction and unstable angina pectoris;
6. With acute cerebral arterial thrombosis;
7. lesion: Severe stenosis or occlusion of distal intracranial vessels;
8. Pregnant women or lactating mothers;
9. With known history of allergy to the drugs of the trial.

Primary outcomes:
measure: The total number of all-cause mortality and all-cause stroke within 12 months
timeFrame: 1 years
Secondary outcomes:
measure: The nature of Vulnerable plaque of carotid artery through color ultrasound
timeFrame: 6 months
measure: The number of Vulnerable plaque of carotid artery through color ultrasound
timeFrame: 6 months
measure: Blood lipid levels
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Guangdong Province Hospital of Tradtional Chinese Medicine
name: Jianwen Guo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.