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

Launched by GUANGDONG PROVINCIAL HOSPITAL OF TRADITIONAL CHINESE MEDICINE · Mar 26, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Tongmai Jiangtang Capsule (TJC) to see if it can help reduce the risk of heart and brain-related problems in older adults who have metabolic syndrome, a condition that increases the chances of heart disease and stroke. The researchers want to find out if TJC can improve long-term health by better managing blood sugar and fat levels. This study will involve many participants and will be conducted in a way that neither the participants nor the researchers know who is receiving the real treatment or a placebo (a non-active pill).

To be eligible for this trial, participants must be at least 65 years old and meet specific health criteria, including having metabolic syndrome and showing signs of a condition called "Qi-deficiency and Blood Stasis," which can involve feelings of fatigue and weakness. Participants should also have a history of serious heart or brain issues, like a heart attack or stroke. Those who are pregnant, have certain severe health conditions, or have had recent health emergencies won't be able to join. If you participate, you can expect regular check-ups and support from the research team as they monitor your health throughout the study.

Gender

ALL

Eligibility criteria

• 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.