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A randomized double-blind placebo-controlled study of Tongxinluo Capsules in the treatment of carotid atherosclerotic plaque

A randomized double-blind placebo-controlled study of Tongxinluo Capsules in the treatment of carotid atherosclerotic plaque

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070091
Enrollment
Unknown
Registered
2023-04-01
Start date
2023-04-01
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

Carotid atherosclerotic plaque

Interventions

Intervention group:Tongxinluo Capsules
Placebo group:Placebo

Sponsors

Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients with carotid atherosclerotic plaque diagnosed by color Doppler ultrasound; 2. Patients aged from 40 to 75 years, regardless of gender; 3. Patients with lumen stenosis less than 70%; 4. Patients who can take medicine for a long time; 5. Patients with informed consent and those who signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with acute cardiovascular and cerebrovascular diseases; 2. Patients with previous history of cerebral hemorrhage; 3. Patients with a positive occult blood test;or patients with active ulcer and bleeding tendency, long-term use of anticoagulant drugs (such as warfarin); 4. Patients with severe arrhythmia, atrial fibrillation and heart failure; 5. Patients with severe primary diseases such as liver, kidney, hematopoietic system, endocrine system and respiratory system, whose liver function is more than 2 times higher than the upper limit of normal value, and Cr is higher than the normal value; 6. Pregnant or lactating women, women with pregnancy plans in the near future; 7. Patients with allergic constitution; 8. Patients who are taking lipid-lowering medications 9. Patients who are taking dual antiplatelet drugs; 10.Patients taking antibiotics for recent 2 weeks 11. Any other life-threatening or serious disease that cannot be treated for 12 months will affect the evaluation results; 12. Other diseases or mental disorders that researchers believe may limit efficacy evaluation or patient follow-up; 13. Pacemaker implantation, metallic foreign bodies in the body, claustrophobia and seizures are contraindicated by MRI; 14. Patients who have participated in clinical trials of other drugs in recent 4 weeks.

Design outcomes

Secondary

MeasureTime frame
Stenosis rate;Intima media thickness;Normal Wall Index;thin fibrous cap;lipid-rich necrotic core volume;intraplaque hemorrhage volume;Plaque calcification volume;fibrous cap volume;blood lipids;blood pressure;hs-CRP;Vital signs;two liver functions;two renal function;

Primary

MeasureTime frame
Total plaque volume;

Countries

China

Contacts

Public ContactShengxian Wu

Dongzhimen Hospital of Beijing University of traditional Chinese Medicine

wushx@sina.com+86 13501382919

Outcome results

None listed

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