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Evaluation of the clinical efficacy of Guanxinning tablets in the treatment of patients with carotid atherosclerotic plaque

Evaluation of the clinical efficacy of Guanxinning tablets in the treatment of patients with carotid atherosclerotic plaque

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100005440
Enrollment
Unknown
Registered
2021-12-24
Start date
2021-12-21
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Carotid atherosclerotic plaque formation

Interventions

test group :Conventional treatment + Guanxinning tablets

Sponsors

Dongzhimen Hospital, Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Participate voluntarily, understand and sign the informed consent form (2) Age =18 years old and =75 years old, regardless of gender (3) Meet the diagnostic criteria: IMT=1.5mm, protruding from the vascular cavity or limited thickening, And higher than 50% of the surrounding IMT (4) Syndrome differentiation accords with TCM "Heart and Blood Stasis Syndrome"

Exclusion criteria

Exclusion criteria: (1) Carotid artery plaque stenosis =70% (2) History of carotid endarterectomy (3) Poor hypertension control, defined as resting at two independent examinations before randomization Systolic blood pressure =180mmHg and/or diastolic blood pressure =110mmHg (4) Occurred within 3 months: acute coronary syndrome, stroke, transient brain deficiency Blood attack; heart, carotid or other large blood vessel surgery; percutaneous coronary intervention or carotid movement Angioplasty or coronary artery bypass graft and other heart surgery (5) Major surgery within 6 months before randomization (6) Patients with hemoglobin concentration =9g/dL and/or blood system diseases (7) Patients with heart failure and severe arrhythmia (persistent rapid atrial fibrillation, atrial flutter, frequent Ventricular premature, ventricular tachycardia, atrioventricular block above second degree), or combined with liver, kidney, hematopoietic system, Nervous system, endocrine system and other serious primary diseases, tumor patients and mental patients (8) Life expectancy is less than 1 year (9) Participated in other drug clinical trials within 1 month (10) Known to be allergic to the research drug (including its ingredients) (11) Patients who are taking Chinese medicines or proprietary Chinese medicines that have similar ingredients to Guanxinning tablets or have the effect of resolving phlegm and turbidity (12) Pregnancy (positive pregnancy test) or breastfeeding; failure to take medicine Use women of childbearing age (15-49 years old) who observe strict contraceptive measures (13) According to the judgement of the investigator, the patient cannot complete the study or cannot comply with the requirements of the study Demand (due to management reasons or other reasons)

Design outcomes

Primary

MeasureTime frame
Carotid artery intima-media thickness;

Secondary

MeasureTime frame
Segmental fat analysis;Blood lipids;Cardiovascular and cerebrovascular disease incidence;Visceral fat grade;Body fat percentage;

Countries

china

Contacts

Public ContactZhang lijing
dzmyyccu@163.com84013181

Outcome results

None listed

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