Tongmai Jiangtang Capsule for Cardiovascular Clinical Outcomes in High-Risk Metabolic Syndrome Patients (TORCH-met)

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Metabolic Syndrome; Cerebrovascular Disease; Cardiovascular Disease (CKD); Qi Deficiency and Blood Stasis
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Estimated): 530
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510405
      • Guangdong Provincial Hospital of Traditional Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group (Tongmai Jiangtang Capsule Group); 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.; 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.
Placebo Comparator: Control Group (Placebo Group); 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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: 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.	From enrollment to the next 52 weeks

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2025
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: March 15, 2025
• First Submitted That Met QC Criteria: March 26, 2025
• First Posted (Actual): April 3, 2025

Study Record Updates

• Last Update Posted (Actual): June 13, 2025
• Last Update Submitted That Met QC Criteria: June 10, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Metabolic Syndrome; High Cardiovascular and Cerebrovascular Risk Metabolic Syndrome, HCR-MS; Qi-Deficiency and Blood Stasis Syndrome; Tongmai Jiangtang Capsule
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Pathologic Processes; Metabolic Diseases; Disease; Glucose Metabolism Disorders; Insulin Resistance; Hyperinsulinism; Syndrome; Cardiovascular Diseases; Metabolic Syndrome; Cerebrovascular Disorders
• Other Study ID Numbers: ZLiu

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No