drugset / Trial / NCT07088523

Traditional Chinese Medicine Intervention for Ischemic Cardiovascular Disease Comorbid With Diabetes Mellitus: An Efficacy Comparative Study

NCT07088523 ↗

Phase 4 Not yet recruiting 4205 enrolled Guangzhou University of Traditional Chinese Medicine
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The population with comorbid ischemic cardiovascular disease (ICD) and diabetes mellitus (DM) has been growing rapidly, characterized by high mortality rates and frequent vascular event recurrence. DM exacerbates ischemic heart disease incidence and significantly elevates mortality in this comorbid population. Polypharmacy in these patients increases risks of adverse drug interactions and imposes substantial healthcare burdens. The pathological mechanisms of comorbidity demonstrate significant alignment with the TCM. Experimental studies indicate that Xintong Oral Liquid can ameliorate myocardial ischemia through multiple mechanisms to improve vascular endothelial function and microvascular dysfunction. This study aims to investigate the long-term effects of TCM intervention in patients with comorbid ICD and DM within 72 hours of symptom onset, and to evaluate whether the TCM treatment approach-centered on Xintong Oral Liquid within an integrated general treatment and syndrome differentiation framework-demonstrates superiority over control therapy in reducing 90-day major adverse cardiovascular and cerebrovascular events (MACCEs).

Timeline

Start
2025-07-31
Primary completion
2026-12-31
Completion
2027-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject TCM Syndrome Differentiation Decoction Traditional medicine (herbal / TCM) — —
Subject Xintong Oral Liquid Unknown 10 ml Oral
Background Aspirin Small molecule 100 mg —
Background Atorvastatin Small molecule 20 mg —
Background Clopidogrel Small molecule 75 mg —
Background Metformin Small molecule 500 mg —