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| Name | Class |
|---|---|
| TCM hospital of Sichuan Province | UNKNOWN |
| Xiyuan Hospital of CACMS | UNKNOWN |
| Shaanxi Provincial Hospital of Chinese Medicine | OTHER |
| First Teaching Hospital of Tianjin University of Traditional Chinese Medicine |
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group (Tongmai Jiangtang Capsule Group) | Experimental | Participants in this Arm will receive Tongmai Jiangtang Capsule (TJC) in addition to standard treatment. Dosage: Three capsules, three times daily (tid), taken orally. Duration: The intervention period is 26 weeks, followed by a 26-week follow-up. Objective: This Arm aims to evaluate the efficacy of TJC in reducing cardiovascular and cerebrovascular event risks in patients with metabolic syndrome at high cardiovascular risk (HCR-MS). Participants will adhere to the study protocol, attending regular visits and examinations to assess efficacy and safety. |
|
| Control Group (Placebo Group) | Placebo Comparator | 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. Dosage: Three placebo capsules, three times daily (tid), taken orally. Duration: The intervention period is 26 weeks, followed by a 26-week follow-up. Objective: This Arm serves as a control to compare the efficacy of TJC against a placebo. Participants will adhere to the study protocol, attending regular visits and examinations to assess the efficacy and safety of the placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Participants will receive Tongmai Jiangtang Capsule (TJC) in addition to standard treatment. | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular death | sudden cardiac death or death due to myocardial infarction, heart failure, stroke, or other cardiovascular causes. | From enrollment to the next 52 weeks |
| Non-fatal myocardial infarction | Including spontaneous, STEMI, NSTEMI, PCI-related, CABG-related, and silent acute myocardial infarction | From enrollment to the next 52 weeks |
| Non-fatal stroke | Meet any one of the following criteria:
| From enrollment to the next 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Composite cardiovascular outcomes | death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization, or hospitalization for unstable angina or heart failure | From enrollment to the next 52 weeks |
| All-cause mortality |
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Inclusion Criteria:
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.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial Hospital of Traditional Chinese Medicine | Guangzhou | Guangdong | 510405 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24176437 | Result | Marso SP, Poulter NR, Nissen SE, Nauck MA, Zinman B, Daniels GH, Pocock S, Steinberg WM, Bergenstal RM, Mann JF, Ravn LS, Frandsen KB, Moses AC, Buse JB. Design of the liraglutide effect and action in diabetes: evaluation of cardiovascular outcome results (LEADER) trial. Am Heart J. 2013 Nov;166(5):823-30.e5. doi: 10.1016/j.ahj.2013.07.012. Epub 2013 Oct 2. |
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| OTHER |
| The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine | OTHER |
| Yinchuan Brain-Heart Simultaneous Treatment Internet Hospital Co., Ltd | UNKNOWN |
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|
| A placebo capsule that is identical in appearance, size, color, formulation, weight, taste, and smell to TJC | Drug | 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. |
|
Any cause of death |
| From enrollment to the next 52 weeks |
| Renal and diabetes-related microvascular composite outcomes | Including renal outcomes or diabetic retinopathy outcomes | From enrollment to the next 52 weeks |
| blood glucose | Including fasting plasma glucose (FPG), 2-hour postprandial blood glucose (2h PPG), and glycated hemoglobin (HbA1c). | From enrollment to the next 52 weeks |
| lipids | Including total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C). | From enrollment to the next 52 weeks |
| Blood pressure | Including systolic blood pressure and systolic blood pressure | From enrollment to the next 52 weeks |
| BMI | Body Mass Index | From enrollment to the next 52 weeks |
| waist-to-hip ratio | waist-to-hip ratio | From enrollment to the next 52 weeks |
| HOMA-IR | HOMA-IR=(Fasting Glucose (mmol/L)×Fasting Insulin (μU/mL))/22.5 | From enrollment to the next 52 weeks |
| Body fat analysis | Including Body Fat Percentage (BFP) and Visceral Fat Index (VFI) | From enrollment to the next 52 weeks |
| Vitamin D levels | Vitamin D levels | From enrollment to the next 52 weeks |
| Assessment of peripheral vascular status | Assessment of plaque or stenosis in the common carotid artery | From enrollment to the next 52 weeks |
| Cardiac function | Including Cardiac Enzymes, Troponin, BNP, Ejection Fraction (EF), Left Ventricular Myocardial Thickness, and Interventricular Septal Thickness. | From enrollment to the next 52 weeks |
| Cardiovascular risk indices | Including the China-PAR Score, Framingham Risk Score, and QRISK3 Score. | From enrollment to the next 52 weeks |
| Traditional Chinese medicine symptom scores | Including symptoms related to observation, hearing, questioning, and palpation. | From enrollment to the next 52 weeks |
| Quality of life scores. | The Short-From-36 Health Survey, SF-36 | From enrollment to the next 52 weeks |
| Omics analysis | Including transcriptomics, proteomics, untargeted metabolomics, and microbiome analysis. | From enrollment to the next 52 weeks |
| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D002318 | Cardiovascular Diseases |
| D002561 | Cerebrovascular Disorders |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D003116 | Color |
| D004304 | Dosage Forms |
| D014894 | Weights and Measures |
| D013649 | Taste |
| ID | Term |
|---|---|
| D008027 | Light |
| D055620 | Optical Phenomena |
| D055585 | Physical Phenomena |
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |
| D012677 | Sensation |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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