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A randomized double-blind placebo-controlled study of Neixiao Ruanmai Decoction in the treatment of carotid atherosclerotic plaque

A randomized double-blind placebo-controlled study of neixiao Ruanmai Decoction in the treatment of carotid atherosclerotic plaque

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068761
Enrollment
Unknown
Registered
2023-02-28
Start date
2022-09-01
Completion date
Unknown
Last updated
2023-05-22

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:Neixiao Ruanmai Decoction
Control group:Neixiao Ruanmai Placebo

Sponsors

Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients with carotid atherosclerotic plaque diagnosed by color Doppler ultrasound; 2. Patients aged from 40 to 65 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 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 1.5 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. Any other life-threatening or serious disease that cannot be treated for 12 months will affect the evaluation results; 11. Other diseases or mental disorders that researchers believe may limit efficacy evaluation or patient follow-up; 12. Pacemaker implantation, metallic foreign bodies in the body, claustrophobia and seizures are contraindicated by MRI; 13. Patients who have participated in clinical trials of other drugs in recent 4 weeks.

Design outcomes

Primary

MeasureTime frame
Total plaque volume;

Secondary

MeasureTime frame
Stenosis rate;Intima media thickness;Plaque thickness reduction;Percentage decrease in plaque thickness (cross section);Plaque area decline;Percentage of plaque area decrease (longitudinal section);blood lipids;blood pressure;hs-CRP;SAA;

Countries

China

Contacts

Public ContactShengxian Wu

Dongzhimen Hospital of Beijing University of traditional Chinese Medicine

wushx@sina.com13501382919

Outcome results

None listed

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