Tongmai Jiangtang Capsule for Cardiovascular Clinical Outcomes in High-Risk Metabolic Syndrome Patients

Phase 3

• Conditions: Metabolic Syndrome; Cardiovascular Disease (CKD); Cerebrovascular Disease; Qi Deficiency and Blood Stasis
• Interventions: Drug: Participants will receive Tongmai Jiangtang Capsule (TJC) in addition to standard treatment.; Drug: A placebo capsule that is identical in appearance, size, color, formulation, weight, taste, and smell to TJC

• Registration Number: NCT06908473
• Lead Sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-15
• Study First Submitted QC: 2025-03-26
• Study First Posted: 2025-04-03
• Study Start: 2025-04-24
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-10
• Last Update Posted: 2025-06-13
• Primary Completion: 2028-07-31
• Study Completion: 2028-07-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 530

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group (Tongmai Jiangtang Capsule Group)	Participants will receive Tongmai Jiangtang Capsule (TJC) in addition to standard treatment.	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)	A 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. 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.

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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
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
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)
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
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.

Trial Locations

Locations (1)

Guangdong Provincial Hospital of Traditional Chinese Medicine; 🇨🇳 Guangzhou, Guangdong, China