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

NCT06908473 | Enrolling By Invitation Phase 3 DMC

• 1 other identifier: ZLiu
• Study Type: interventional
• Target: 530
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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.

Conditions

Metabolic Syndrome; Cardiovascular Disease (CKD); Cerebrovascular Disease; Qi Deficiency and Blood Stasis

Keywords

Metabolic Syndrome; High Cardiovascular and Cerebrovascular Risk Metabolic Syndrome, HCR-MS; Qi-Deficiency and Blood Stasis Syndrome; Tongmai Jiangtang Capsule

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (17)

• Composite cardiovascular outcomes

  From enrollment to the next 52 weeks

• All-cause mortality

  From enrollment to the next 52 weeks

• Renal and diabetes-related microvascular composite outcomes

  From enrollment to the next 52 weeks

• blood glucose

  From enrollment to the next 52 weeks

• lipids

  From enrollment to the next 52 weeks

Study Arms (2)

Experimental Group (Tongmai Jiangtang Capsule Group)

EXPERIMENTAL

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.

Control Group (Placebo Group)

PLACEBO COMPARATOR

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

Interventions

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.

Experimental Group (Tongmai Jiangtang Capsule Group)

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.

Control Group (Placebo Group)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Guangdong Provincial Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, 510405, China

Location

Related Publications (1)

• 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.

  PMID: 24176437 BACKGROUND

MeSH Terms

Conditions

Metabolic Syndrome; Cardiovascular Diseases; Cerebrovascular Disorders

Interventions

Color; Dosage Forms; Weights and Measures; Taste

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Light; Optical Phenomena; Physical Phenomena; Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques; Sensation; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: March 15, 2025
• First Posted: April 3, 2025
• Study Start: April 24, 2025
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)