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

PHASE3Enrolling by invitationINTERVENTIONAL
Enrollment

530

Participants

Timeline

Start Date

April 24, 2025

Primary Completion Date

July 31, 2028

Study Completion Date

July 31, 2028

Conditions
Metabolic SyndromeCardiovascular Disease (CKD)Cerebrovascular DiseaseQi 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.

Trial Locations (1)

510405

Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou

All Listed Sponsors
collaborator

TCM hospital of Sichuan Province

UNKNOWN

collaborator

Xiyuan Hospital of CACMS

UNKNOWN

collaborator

Shanxi Provincial hospital of Chinese Medicine

UNKNOWN

collaborator

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

OTHER

collaborator

The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

OTHER

collaborator

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

UNKNOWN

lead

Guangdong Provincial Hospital of Traditional Chinese Medicine

OTHER