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

June 10, 2025 updated by: Zhenjie Liu, Guangdong Provincial Hospital of Traditional Chinese Medicine

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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
530

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the next 52 weeks
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
From enrollment to the next 52 weeks
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.
From enrollment to the next 52 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
From enrollment to the next 52 weeks
All-cause mortality
Time Frame: From enrollment to the next 52 weeks
Any cause of death
From enrollment to the next 52 weeks
Renal and diabetes-related microvascular composite outcomes
Time Frame: From enrollment to the next 52 weeks
Including renal outcomes or diabetic retinopathy outcomes
From enrollment to the next 52 weeks
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).
From enrollment to the next 52 weeks
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).
From enrollment to the next 52 weeks
Blood pressure
Time Frame: From enrollment to the next 52 weeks
Including systolic blood pressure and systolic blood pressure
From enrollment to the next 52 weeks
BMI
Time Frame: From enrollment to the next 52 weeks
Body Mass Index
From enrollment to the next 52 weeks
waist-to-hip ratio
Time Frame: From enrollment to the next 52 weeks
waist-to-hip ratio
From enrollment to the next 52 weeks
HOMA-IR
Time Frame: From enrollment to the next 52 weeks
HOMA-IR=(Fasting Glucose (mmol/L)×Fasting Insulin (μU/mL))/22.5
From enrollment to the next 52 weeks
Body fat analysis
Time Frame: From enrollment to the next 52 weeks
Including Body Fat Percentage (BFP) and Visceral Fat Index (VFI)
From enrollment to the next 52 weeks
Vitamin D levels
Time Frame: From enrollment to the next 52 weeks
Vitamin D levels
From enrollment to the next 52 weeks
Assessment of peripheral vascular status
Time Frame: From enrollment to the next 52 weeks
Assessment of plaque or stenosis in the common carotid artery
From enrollment to the next 52 weeks
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.
From enrollment to the next 52 weeks
Cardiovascular risk indices
Time Frame: From enrollment to the next 52 weeks
Including the China-PAR Score, Framingham Risk Score, and QRISK3 Score.
From enrollment to the next 52 weeks
Traditional Chinese medicine symptom scores
Time Frame: From enrollment to the next 52 weeks
Including symptoms related to observation, hearing, questioning, and palpation.
From enrollment to the next 52 weeks
Quality of life scores.
Time Frame: From enrollment to the next 52 weeks
The Short-From-36 Health Survey, SF-36
From enrollment to the next 52 weeks
Omics analysis
Time Frame: From enrollment to the next 52 weeks
Including transcriptomics, proteomics, untargeted metabolomics, and microbiome analysis.
From enrollment to the next 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Guangdong Provincial Hospital of Traditional Chinese Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 24, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 15, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 3, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 13, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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