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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
ChiCTR
Registry ID
ChiCTR2100054694
Enrollment
Unknown
Registered
2021-12-24
Start date
2021-12-21
Completion date
Unknown
Last updated
2022-12-05

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

Sponsors

Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Voluntarily participate, understand and sign the informed consent; 2. Aged 18 to 75 years, gender is not limited; 3. Meet the diagnostic criteria: IMT>=1.5mm, protruding from the vascular lumen or localized thickening, and higher than 50% of the surrounding IMT; 4. Syndrome differentiation is in line with TCM "heart-blood stasis syndrome".

Exclusion criteria

Exclusion criteria: 1. Carotid plaque stenosis to >=70%; 2. History of carotid endarterectomy; 3. Poorly controlled hypertension, defined as resting systolic blood pressure >=180 mmHg and/or diastolic blood pressure >=110 mmHg at two independent examinations prior to randomization; 4. Occurred within 3 months: acute coronary syndrome, stroke, transient ischemic attack; cardiac, carotid or other major vessel surgery; percutaneous coronary intervention or carotid angioplasty or coronary artery bypass grafting and other cardiac surgery; 5. Major surgery within 6 months prior to randomization; 6. Hemoglobin concentration <=9g/dL and/or patients with hematological diseases; 7. Combined with heart failure and severe arrhythmia (sustained rapid atrial fibrillation, atrial flutter, frequent ventricular premature beats, ventricular tachycardia, second-degree or higher atrioventricular block), or combined with liver, kidney, hematopoietic system, nervous system, Serious primary diseases such as endocrine system, tumor patients and mental patients; 8. Life expectancy is less than 1 year; 9. Participated in clinical trials of other drugs within 1 month; 10. Known to be allergic to the study drug (including its ingredients); 11. Patients who are taking traditional Chinese medicines or proprietary Chinese medicines with similar composition to Guanxinning Tablets or with the effect of resolving phlegm and turbidity; 12. Pregnancy (positive pregnancy test) or breastfeeding; women of childbearing age (15-49 years old) who fail to use strict contraception during medication; 13. According to the judgment of the investigator, the patient cannot complete the study or comply with the requirements of the study (for administrative reasons or other reasons).

Design outcomes

Primary

MeasureTime frame
Carotid artery intima-media thickness;

Secondary

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

Countries

china

Contacts

Public ContactZhang Lijing

Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine

dzmyyccu@163.com+86 84013181

Outcome results

None listed

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