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The treatment of carotid atherosclerosis with Decoction for Smoothing Qi and resolving phlegmin: a randomized, double-blind, placebo-controlled study

The treatment of carotid atherosclerosis with Decoction for Smoothing Qi and resolving phlegmin: a randomized, double-blind, placebo-controlled study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000004046
Enrollment
Unknown
Registered
2020-09-03
Start date
2020-09-05
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 atherosclerosis

Interventions

Sponsors

Dongzhimen Hospital of Beijing University of traditional 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 with qi stagnation and phlegm coagulation syndrome diagnosed in TCM; 3. Patients aged from 40 to 65 years old, regardless of gender; 4. Patients with lumen stenosis < 70%; 5. Patients who can persist in taking medicine for a long time; 6. Patients who have informed consent and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with acute cardiovascular and cerebrovascular diseases; 2. Patients with previous history of intracerebral hemorrhage; 3. Patients with active ulcer and bleeding tendency, those who take anticoagulant drugs (such as warfarin) for a long time; 4. Patients diagnosed as vulnerable plaque of carotid atherosclerosis; 5. Patients with severe arrhythmia, atrial fibrillation and heart failure; 6. Patients with severe liver, kidney, hematopoietic system, endocrine system, respiratory system and other primary diseases, liver function is more than 1.5 times higher than the upper limit of normal value, and Cr is higher than normal value; 7. Pregnant or lactating women, women with short-term pregnancy plan; 8. Patients with allergic constitution; 9. Patients who are taking lipid-lowering drugs; 11. Patients who are using dual antiplatelet drugs; 12. Patients with any other life-threatening or serious diseases can not complete the treatment for 3 months, so as to affect the evaluation results; 13. Other diseases or mental disorders that may limit the efficacy evaluation or follow-up of the patients, the researchers believe; 14. Patients who have participated in clinical trials of other drugs in the past 4 weeks.

Design outcomes

Primary

MeasureTime frame
Mean intima-media thickness;

Secondary

MeasureTime frame
Decrease of plaque area;Percentage decrease of plaque thickness;Decrease of plaque thickness;TCM syndrome;Carotid artery stenosis rate;blood fat;Percentage decrease of plaque area;

Countries

China

Contacts

Public ContactWu Shengxian

Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine

wushx@sina.com+86 13501382919

Outcome results

None listed

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