A Phase 3 interventional study of Participants will receive Tongmai Jiangtang Capsule (TJC) in addition to standard treatment. and A placebo capsule that is identical in appearance, size, color, formulation, weight, taste, and smell to TJC in Metabolic Syndrome, Cardiovascular Disease (CKD) and Cerebrovascular Disease, sponsored by Guangdong Provincial Hospital of Traditional Chinese Medicine. Enrolling by invitation at 1 site in China. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-06-13.
Sponsored by Guangdong Provincial Hospital of Traditional Chinese Medicine · Phase 3, Interventional, and Treatment
2,116 studies on the registry are indexed under Metabolic Syndrome; 347 are open to participants now.
This study's planned enrollment of 530 is above the median of 60 across 1,572 interventional studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →Guangdong Provincial Hospital of Traditional Chinese Medicine is the lead sponsor of 42 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Low HDL cholesterol: Fasting HDL-C \<1.04 mmol/L.
High Cardiovascular Risk: Participants must have at least one of the following:
History of myocardial infarction.
History of stroke or . 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 changes.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Participants will receive Tongmai Jiangtang Capsule (TJC) in addition to standard treatment.
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.
Drug: A placebo capsule that is identical in appearance, size, color, formulation, weight, taste, and smell to TJC
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.
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.
Cardiovascular death
sudden cardiac death or death due to myocardial infarction, heart failure, stroke, or other cardiovascular causes.
Time frame: From enrollment to the next 52 weeks
Non-fatal myocardial infarction
Including spontaneous, STEMI, NSTEMI, PCI-related, CABG-related, and silent acute myocardial infarction
Time frame: From enrollment to the next 52 weeks
Non-fatal stroke
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.
Time frame: From enrollment to the next 52 weeks
Composite cardiovascular outcomes
death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization, or hospitalization for unstable angina or heart failure
Time frame: From enrollment to the next 52 weeks
All-cause mortality
Any cause of death
Time frame: From enrollment to the next 52 weeks
Renal and diabetes-related microvascular composite outcomes
Including renal outcomes or diabetic retinopathy outcomes
Time frame: 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).
Time frame: 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).
Time frame: From enrollment to the next 52 weeks
Blood pressure
Including systolic blood pressure and systolic blood pressure
Time frame: From enrollment to the next 52 weeks
BMI
Body Mass Index
Time frame: From enrollment to the next 52 weeks
waist-to-hip ratio
waist-to-hip ratio
Time frame: From enrollment to the next 52 weeks
HOMA-IR
HOMA-IR=(Fasting Glucose (mmol/L)×Fasting Insulin (μU/mL))/22.5
Time frame: From enrollment to the next 52 weeks
Body fat analysis
Including Body Fat Percentage (BFP) and Visceral Fat Index (VFI)
Time frame: From enrollment to the next 52 weeks
Vitamin D levels
Vitamin D levels
Time frame: From enrollment to the next 52 weeks
Assessment of peripheral vascular status
Assessment of plaque or stenosis in the common carotid artery
Time frame: 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.
Time frame: From enrollment to the next 52 weeks
Cardiovascular risk indices
Including the China-PAR Score, Framingham Risk Score, and QRISK3 Score.
Time frame: From enrollment to the next 52 weeks
Traditional Chinese medicine symptom scores
Including symptoms related to observation, hearing, questioning, and palpation.
Time frame: From enrollment to the next 52 weeks
Quality of life scores.
The Short-From-36 Health Survey, SF-36
Time frame: From enrollment to the next 52 weeks
Omics analysis
Including transcriptomics, proteomics, untargeted metabolomics, and microbiome analysis.
Time frame: From enrollment to the next 52 weeks
Plan to share: Yes
Supporting information: Study protocol
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Guangdong Provincial Hospital of Traditional Chinese Medicine