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Traditional Chinese Medicine Intervention for Ischemic Cardiovascular Disease Comorbid With Diabetes Mellitus: An Efficacy Comparative Study
Sponsor: Guangzhou University of Traditional Chinese Medicine
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).
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
4205
Start Date
2025-07-31
Completion Date
2027-12-31
Last Updated
2025-07-28
Healthy Volunteers
No
Interventions
Xintong Oral Liquid (Sequential Phase)
Xintong Oral Liquid (Lunan Pharmaceutical), 10 mL tid po from week 5 to 52.
Xintong Oral Liquid (Intensive Phase)
Xintong Oral Liquid (Lunan Pharmaceutical), 20 mL tid po for 4 weeks.
TCM Syndrome Differentiation Decoction
Individualized herbal decoction based on TCM diagnosis (four diagnostic methods), administered for 14 days during intensive phase.
Standard Treatment (Guideline-Based)
Combination therapy including: 1. Antiplatelet: aspirin 100 mg/day + clopidogrel 75 mg/day. 2. Lipid-lowering: atorvastatin 20 mg/day. 3. Antidiabetic: metformin 500 mg bid (max 2000 mg/day). \*Doses may be adjusted per local guidelines or patient tolerance.
Locations (1)
Guangdong Traditional Chinese Medicine Hospital
Guangzhou, Guangdong, China