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Clinical study on the efficacy and safety of AS plaques by regulating 1L17A/NF-KB pathway mediated macrophage polarization based on the theory of "Qi Channel and blood collaterality"

Clinical study on the efficacy and safety of AS plaques by regulating 1L17A/NF-KB pathway mediated macrophage polarization based on the theory of "Qi Channel and blood collaterality"

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001394
Enrollment
Unknown
Registered
2025-07-12
Start date
2025-08-01
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerotic plaque

Interventions

Experimental group:CS001 capsule, 4 capsules at a time, 3 times/day

Sponsors

School of Public Health, Zhejiang Chinese Medicine University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) The ultrasound diagnostic criteria for carotid atherosclerotic plaque were met; (2) Conforming to the diagnosis of TCM syndromes and accompanied by relevant clinical symptoms in TCM. (3) Age 18-75 years old (including 18 years old and 75 years old) male or female; (4) Bilateral or unilateral carotid atherosclerotic lesions; (5) intima-media thickness (IMT)=1.2mm; (6) Carotid ultrasound diagnosis of mild to moderate stenosis (<70%) plaque stability and no surgical intervention; (7) Sign informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients with atherosclerotic diseases have been diagnosed including coronary heart disease stroke peripheral vascular disease renal artery stenosis etc.; (2) Subjects with hemoglobin 7.8mmol/L LDL-C>5.0mmol/L); (12) Patients with severe hypertension and poor blood pressure control after intervention treatment (=160/90mmHg); (13) Heart failure and severe arrhythmia (persistent rapid atrial fibrillation atrial flutter frequent ventricular premature ventricular tachycardia second degree or more atrioventricular block); (14) Liver function AST ALT > 2N (N is the upper limit of normal value); Serum creatinine (Scr) > 176umol/L; (15) Patients with a life expectancy of less than 1 year; (16) Subjects with intellectual disability or mental illness who are unable to cooperate; (17) People who are allergic or allergic to the experimental drug (allergic to two or more foods or drugs); (18) Women who are pregnant breastfeeding and preparing to become pregnant;

Design outcomes

Primary

MeasureTime frame
Carotid plaque thickness;

Secondary

MeasureTime frame
The incidence rate of cardiovascular and cerebrovascular events;Narrowing rate of the lumen;Plaque stability;The therapeutic effect of individual TCM syndromes;The average intima-media thickness of the carotid artery (the average value of the inner middle layer of the carotid artery at 1 cm and 2 cm from the bifurcation of the common carotid artery on both sides and 1 cm from the bifurcation of the internal carotid artery on both sides);Curative effect of TCM syndrome;Lipid change;Carotid plaque area;

Countries

china

Contacts

Public Contactwang hongyang

School of Public Health Zhejiang Chinese Medicine University

wanghongyang0108@163.com+86 188 4619 7006

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026