The significance of monocyte subsets changes induced by gut microbial metabolites in AS and the intervention mechanism research of Huatan Quyu Jiedu Tongmai Formula

Phase 1

• Conditions: atherosclerosis and blood-lipid metabolic disorder

• Registration Number: ITMCTR1900002730
• Lead Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences

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: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Aged 25-65 years old, male or female;
2. TCM Syndrome differentiation is phlegm stasis;
3. Meeting the diagnostic criteria of atherosclerosis and blood-lipid metabolic disorder;
4. Patients with carotid intima-media thickness (IMT)>=1.0mm or visible plaque and carotid artery stenosis < 70%;
5. Patients with smoking history (>20 cigarettes per day), obesity (BMI >28), hyperlipidemia and family history;
6. The basic principle of freely given informed consent for all subjects.

Exclusion Criteria

1. Patients with chest pain, dizziness and headache due to cardio-cerebrovascular diseases, such as unstable angina, myocardial infarction, etc. or caused by severe neurosis, menopausal syndrome, other chest diseases and craniocerebral lesions, such as vasculogenic stroke, etc.;
2. Severe liver and kidney function damage, with alanine aminotransferase> 3 times of the upper limit of normal, or serum creatinine was high than the upper limit;
3. Combined with major systemic diseases such as the nervous system, and immune system, or poorly controlled chronic diseases such as hypertension and diabetes;
4. Those who have complicated accompanying syndromes, including deficiency of 'qi' and 'yi', 'zhong-qi sinking' or 'hyperactivity of liver yang';
5. Allergy constitution;
6. Women of child-bearing age who are in pregnancy or lactation;
7. Patients who participated in other drug clinical trials in the past 1 months;
8. Mental disorders who failure to correctly express wishes or communicate;
9. Drug abusers or addicts.

Study & Design

• Study Type: Basic Science
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maximum IMT of anterior and posterior walls of carotid artery;The syndrome scorings of the phlegm stasis;

Secondary Outcome Measures

Name	Time	Method
Maximum plaque area of short and long axis of carotid artery;vascular endothelial function;The four methods of diagnosis;Blood biochemistry;Carotid stenosis rate or vessel diameter;