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Enrolling by Invitation

NCT Number: NCT06908473

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

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.

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Key information

Conditions

Metabolic Syndrome Brain Diseases Cardiovascular Disease (CKD) Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disease Cerebrovascular Disorders Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Qi Deficiency and Blood Stasis Vascular Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Guangdong Provincial Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, 510405, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Cardiovascular death

    Time frame: From enrollment to the next 52 weeks

    sudden cardiac death or death due to myocardial infarction, heart failure, stroke, or other cardiovascular causes.

  2. Non-fatal myocardial infarction

    Time frame: From enrollment to the next 52 weeks

    Including spontaneous, STEMI, NSTEMI, PCI-related, CABG-related, and silent acute myocardial infarction

  3. Non-fatal stroke

    Time frame: 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 outcomes

  1. Composite cardiovascular outcomes

    Time frame: 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

  2. All-cause mortality

    Time frame: From enrollment to the next 52 weeks

    Any cause of death

  3. Renal and diabetes-related microvascular composite outcomes

    Time frame: From enrollment to the next 52 weeks

    Including renal outcomes or diabetic retinopathy outcomes

  4. blood glucose

    Time frame: From enrollment to the next 52 weeks

    Including fasting plasma glucose (FPG), 2-hour postprandial blood glucose (2h PPG), and glycated hemoglobin (HbA1c).

  5. lipids

    Time frame: 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).

  6. Blood pressure

    Time frame: From enrollment to the next 52 weeks

    Including systolic blood pressure and systolic blood pressure

  7. BMI

    Time frame: From enrollment to the next 52 weeks

    Body Mass Index

  8. waist-to-hip ratio

    Time frame: From enrollment to the next 52 weeks

    waist-to-hip ratio

  9. HOMA-IR

    Time frame: From enrollment to the next 52 weeks

    HOMA-IR=(Fasting Glucose (mmol/L)×Fasting Insulin (μU/mL))/22.5

  10. Body fat analysis

    Time frame: From enrollment to the next 52 weeks

    Including Body Fat Percentage (BFP) and Visceral Fat Index (VFI)

  11. Vitamin D levels

    Time frame: From enrollment to the next 52 weeks

    Vitamin D levels

  12. Assessment of peripheral vascular status

    Time frame: From enrollment to the next 52 weeks

    Assessment of plaque or stenosis in the common carotid artery

  13. Cardiac function

    Time frame: From enrollment to the next 52 weeks

    Including Cardiac Enzymes, Troponin, BNP, Ejection Fraction (EF), Left Ventricular Myocardial Thickness, and Interventricular Septal Thickness.

  14. Cardiovascular risk indices

    Time frame: From enrollment to the next 52 weeks

    Including the China-PAR Score, Framingham Risk Score, and QRISK3 Score.

  15. Traditional Chinese medicine symptom scores

    Time frame: From enrollment to the next 52 weeks

    Including symptoms related to observation, hearing, questioning, and palpation.

  16. Quality of life scores.

    Time frame: From enrollment to the next 52 weeks

    The Short-From-36 Health Survey, SF-36

  17. Omics analysis

    Time frame: From enrollment to the next 52 weeks

    Including transcriptomics, proteomics, untargeted metabolomics, and microbiome analysis.

Sponsors and collaborators

Lead sponsor

Guangdong Provincial Hospital of Traditional Chinese Medicine

Other

Collaborators

  • First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
  • Shaanxi Provincial Hospital of Chinese Medicine
  • TCM hospital of Sichuan Province
  • The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
  • Xiyuan Hospital of CACMS
  • Yinchuan Brain-Heart Simultaneous Treatment Internet Hospital Co., Ltd

Registry information

Official study title

A Multicenter, Double-Blind, Randomized Controlled Study on the Impact of Tongmai Jiangtang Capsules on the Risk of Cardiovascular and Cerebrovascular Events in Metabolic Syndrome

Acronym: TORCH-met

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Apr 3, 2025
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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