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

Phase 1

Recruiting

• Conditions: Carotid atherosclerosis

• Registration Number: ITMCTR2000004046
• Lead Sponsor: Dongzhimen Hospital of Beijing University of traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean intima-media thickness;

Secondary Outcome Measures

Name	Time	Method
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;