Cardiovascular Disease (CKD), Cerebrovascular Disease, Metabolic Syndrome, Qi Deficiency and Blood Stasis
Conditions
Keywords
Metabolic Syndrome, High Cardiovascular and Cerebrovascular Risk Metabolic Syndrome, HCR-MS, Qi-Deficiency and Blood Stasis Syndrome, Tongmai Jiangtang Capsule
Brief summary
1. Conduct a large-sample, multicenter, superiority, double-blind, randomized controlled clinical trial to verify the efficacy of TJC in reducing the risk of cardiovascular and cerebrovascular events in patients with metabolic syndrome at high cardiovascular and cerebrovascular risk (HCR-MS). 2. Further construct an evaluation system for the long-term cardiovascular and cerebrovascular benefits of traditional Chinese medicine in regulating glucose and lipid metabolism through the evaluative study of the cardiovascular and cerebrovascular benefits of TJC.
Interventions
DRUGParticipants will receive Tongmai Jiangtang Capsule (TJC) in addition to standard treatment.
Intervention Agent: The study employs Tongmai Jiangtang Capsule (TJC), a traditional Chinese medicine compound formulated based on TCM theory. It has the functions of Nourishing Yin, clearing heat and activating blood circulation, and can comprehensively regulate glucose and lipid metabolism as well as improve cardiovascular and cerebrovascular functions. Intervention Population: The study focuses on patients with metabolic syndrome at high cardiovascular and cerebrovascular risk (HCR-MS) who meet the TCM criteria for Qi-deficiency and Blood Stasis syndrome, reflecting personalized and precision intervention. Intervention Design: A long-term study design with 26 weeks of intervention followed by 26 weeks of follow-up is adopted to comprehensively assess the short-term efficacy and long-term cardiovascular benefits of TJC. Control Design: The study employs a double-blind, randomized, placebo-controlled method.
DRUGA placebo capsule that is identical in appearance, size, color, formulation, weight, taste, and smell to TJC
Participants in this Arm will receive a placebo capsule that is identical in appearance, size, color, formulation, weight, taste, and smell to TJC, in addition to standard treatment.
Sponsors
TCM hospital of Sichuan Province
Xiyuan Hospital of CACMS
Shanxi Provincial hospital of Chinese Medicine
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Yinchuan Brain-Heart Simultaneous Treatment Internet Hospital Co., Ltd
Guangdong Provincial Hospital of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age: Participants must be aged ≥65 years. * Participants must meet the diagnostic criteria for metabolic syndrome according to the 2020 Chinese Type 2 Diabetes Prevention Guidelines, which includes at least three of the following criteria:①Central obesity: Waist circumference ≥90 cm for men, ≥85 cm for women.②Hyperglycemia: Fasting blood glucose ≥6.1 mmol/L or 2-hour post-load glucose ≥7.8 mmol/L, or a confirmed diagnosis of diabetes with ongoing treatment.③Hypertension: Blood pressure ≥130/85 mmHg or a confirmed diagnosis of hypertension with ongoing treatment.④Elevated triglycerides (TG): ⑤Fasting TG ≥1.70 mmol/L. Low HDL cholesterol: Fasting HDL-C \<1.04 mmol/L. * Participants must meet the criteria for Qi-deficiency and Blood Stasis syndrome, which includes specific symptoms and signs such as fatigue, shortness of breath, stabbing pain, ecchymosis, and a tongue with purple discoloration or petechiae. * High Cardiovascular Risk: Participants must have at least one of the following: * History of myocardial infarction. * History of stroke or transient ischemic attack. ③History of coronary, carotid, or peripheral artery revascularization. * Coronary, carotid, or lower limb artery stenosis \>50%. ⑤Positive exercise stress test or documented symptomatic coronary heart disease, or unstable angina with ECG changes. * Chronic heart failure (NYHA Class II-III). ⑦Chronic kidney disease (eGFR \<60 ml/min/1.73m²).
Exclusion criteria
* Secondary Abnormalities: Secondary abnormalities in lipids, blood pressure, or blood glucose. * Type 1 Diabetes: Participants with Type 1 diabetes mellitus. * Special Populations: Pregnant or breastfeeding individuals, or those with a history of allergy to the study medication. * Recent Acute Events: Acute coronary or cerebrovascular events within the past 14 days. * Upcoming Revascularization: Planned coronary, carotid, or peripheral artery revascularization. * Severe Heart Failure: Chronic heart failure (NYHA Class IV). * End-Stage Liver Disease: Participants with end-stage liver disease. * Solid Organ Transplantation: History of solid organ transplantation or awaiting solid organ transplantation. * Malignant Tumors: Participants with a history of malignant tumors. * Other Serious Conditions: Any other serious medical conditions that may interfere with the study or pose a risk to the participant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular death | From enrollment to the next 52 weeks | sudden cardiac death or death due to myocardial infarction, heart failure, stroke, or other cardiovascular causes. |
| Non-fatal myocardial infarction | From enrollment to the next 52 weeks | Including spontaneous, STEMI, NSTEMI, PCI-related, CABG-related, and silent acute myocardial infarction |
| Non-fatal stroke | From enrollment to the next 52 weeks | Meet any one of the following criteria: * Acute neurological dysfunction documented by CT/MRI, attributable to vascular causes with other etiologies excluded; ② Transient ischemic attack (TIA) lasting \<24 hours; ③ Microhemorrhage: Round hypointense lesions \<5-10 mm on MRI. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| blood glucose | From enrollment to the next 52 weeks | Including fasting plasma glucose (FPG), 2-hour postprandial blood glucose (2h PPG), and glycated hemoglobin (HbA1c). |
| lipids | From enrollment to the next 52 weeks | Including total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C). |
| Blood pressure | From enrollment to the next 52 weeks | Including systolic blood pressure and systolic blood pressure |
| BMI | From enrollment to the next 52 weeks | Body Mass Index |
| waist-to-hip ratio | From enrollment to the next 52 weeks | waist-to-hip ratio |
| HOMA-IR | From enrollment to the next 52 weeks | HOMA-IR=(Fasting Glucose (mmol/L)×Fasting Insulin (μU/mL))/22.5 |
| Body fat analysis | From enrollment to the next 52 weeks | Including Body Fat Percentage (BFP) and Visceral Fat Index (VFI) |
| Composite cardiovascular outcomes | From enrollment to the next 52 weeks | death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization, or hospitalization for unstable angina or heart failure |
| Assessment of peripheral vascular status | From enrollment to the next 52 weeks | Assessment of plaque or stenosis in the common carotid artery |
| Cardiac function | From enrollment to the next 52 weeks | Including Cardiac Enzymes, Troponin, BNP, Ejection Fraction (EF), Left Ventricular Myocardial Thickness, and Interventricular Septal Thickness. |
| Cardiovascular risk indices | From enrollment to the next 52 weeks | Including the China-PAR Score, Framingham Risk Score, and QRISK3 Score. |
| Traditional Chinese medicine symptom scores | From enrollment to the next 52 weeks | Including symptoms related to observation, hearing, questioning, and palpation. |
| Quality of life scores. | From enrollment to the next 52 weeks | The Short-From-36 Health Survey, SF-36 |
| Omics analysis | From enrollment to the next 52 weeks | Including transcriptomics, proteomics, untargeted metabolomics, and microbiome analysis. |
| Vitamin D levels | From enrollment to the next 52 weeks | Vitamin D levels |
| All-cause mortality | From enrollment to the next 52 weeks | Any cause of death |
| Renal and diabetes-related microvascular composite outcomes | From enrollment to the next 52 weeks | Including renal outcomes or diabetic retinopathy outcomes |
Countries
China
Outcome results
None listed