Metabolic Syndrome
Conditions
Interventions
Experimental Group:Participants in this group will receive TJC capsules in addition to standard treatment. Dose: 3 capsules 3 times daily (tid) by mouth. Duration: Intervention period of 26 weeks, fol
Placebo Group:In addition to standard treatment, participants in this group will receive a placebo capsule that is identical to TJC in appearance, size, color, formulation, weight, taste and odor. Dos
Sponsors
Guangdong Provincial Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
65 Years to 100 Years
Inclusion criteria
Inclusion criteria: INCLUSION CRITERIA: 4 of the following were met simultaneously (1) Age at =65 years (2) Patients meeting the diagnosis of metabolic syndrome (3) Meet the criteria of qi deficiency and blood stasis syndrome (4) People with high cardiovascular and cerebrovascular risk meeting any one of the following criteria: (1) Previous myocardial infarction 2) Previous stroke or transient cerebral hemorrhage Previous history of coronary carotid or peripheral arterial revascularization 4) Coronary carotid or lower extremity arterial stenosis >50% 5) Positive exercise stress test or history of symptomatic coronary artery disease documented by any cardiac imaging or unstable angina with electrocardiographic changes 6) Chronic heart failure (NYHA class II-III) 7)Chronic kidney disease (eGFR <60 ml/min/1.73 m2)
Exclusion criteria
Exclusion criteria: Exclusion criteria: Participants meeting any of the following conditions will be excluded. (1) Secondary lipid blood pressure or blood glucose abnormalities; (2) Type 1 diabetes; (3) Special populations such as pregnancy lactation or those with a history of allergy to the study medications; (4) Acute coronary or cerebrovascular events in the past 14 days; (5) Current plans for coronary carotid or peripheral artery reconstruction surgery; (6) Chronic heart failure (NYHA Class IV); (7) Undergoing continuous renal replacement therapy; (8) End-stage liver disease; (9) History of solid organ transplantation or currently awaiting solid organ transplantation; (10) Malignant tumors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite cardiovascular outcomes;Non-fatal myocardial infarction;All due to death;Cardiovascular causes of death and causes;Non-fatal stroke;Renal and Glucose-Related Retinal Microvascular Complex Outcomes; | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of peripheral vascular status;Vitamin D levels;Myocardial condition;Omics analysis;lipids;blood glucose;Traditional Chinese medicine symptom scores;Homeostatic Model Assessment of Insulin Resistance;waist-to-hip ratio;Blood pressure;Quality of life scores.;Cardiovascular Risk Assessment Index;Body Mass Index;Body fat analysis; | — |
Countries
China
Contacts
Public ContactZhenjie Liu
Guangdong Provincial Hospital of Traditional Chinese Medicine
Outcome results
None listed