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

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.

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.

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.

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.

Sponsors & Collaborators

• TCM hospital of Sichuan Province

  collaborator UNKNOWN

• Xiyuan Hospital of CACMS

  collaborator UNKNOWN

• Shanxi Provincial hospital of Chinese Medicine

  collaborator UNKNOWN

• First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

  collaborator OTHER

• The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

  collaborator OTHER

• Yinchuan Brain-Heart Simultaneous Treatment Internet Hospital Co., Ltd

  collaborator UNKNOWN

• Guangdong Provincial Hospital of Traditional Chinese Medicine

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-24

Primary Completion

2028-07-31

Completion

2028-07-31

Countries

• China

Study Locations