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

NCT07088523 · tracked via the Priya Life Science China tracker

Sponsor

Guangzhou University of Traditional Chinese Medicine

Phase

Phase 4

Started

2025-07-31

Last updated

2025-07-28

Condition(s) studied

Diabete MellitusIschemic Cardiovascular Disease

Investigational drug(s) / intervention(s)

Xintong Oral Liquid (Sequential Phase)Xintong Oral Liquid (Intensive Phase)TCM Syndrome Differentiation DecoctionStandard Treatment (Guideline-Based)

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.

Study 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).

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: * Age\>18 years; * Met the diagnostic criteria for myocardial infarction and type 2 diabetes mellitus; * Within 72 hours of myocardial infarction onset; * Met the diagnostic criteria of "toxins damaging collaterals"； * Voluntary participation in the study with consent forms signed. Exclusion Criteria: * Long-term (\>20 min) cardio-pulmonary resuscitation (CPR); * Critical illness due to STEMI (such as serious cardiogenic shock, uncontrolled acute left heart failure or pulmonary edema, malignant arrhythmias, explicit mechanical complications, etc. ); * Suspected aortic dissection or acute pulmonary embolism; * Bleeding history in any organ system within 1 month, or presence of active hemorrhage at any part of the body, or known hemorrhagic constitution, or severe coagulation disorder or current usage of anticoagulants; * Uncontrolled severe diabetic ketoacidosis; * Serious hepatic dysfunction or serious renal dysfunction ( ALT/AST≥3 ULN or eGFR\<30mL/min/1.73 m2 or equiring dialysis ); * Serious COPD or respiratory failure; * Severe infection (such as positive blood cultures, septic shock, and septic pneumonia, etc.); * Neuropsychiatric system diseases or unconscious and unable to cooperate with examination and treatment; * Malignancies or other conditions with expected survival time\<1 year or unsuitability to participate in this study due to other diseases; * Allergy to the ingredients of the research drugs; * Women who are in pregnancy or nursery; * Participation in clinical trial of other traditional Chinese medicine.

Primary outcome measure(s)

90-day Major Adverse Cardiovascular and Cerebrovascular Events (MACCEs) — 90 days
Composite of: 1) Myocardial re-infarction (Third Universal Definition of MI); 2) Emergent coronary revascularization; 3) Stroke (NIHSS ≥1, imaging-confirmed); 4) Cardiovascular death (adjudicated by endpoint committee).

Trial sites (1)

Facility	City	Region	Status
Guangdong Traditional Chinese Medicine Hospital	Guangzhou	Guangdong

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07088523 on ClinicalTrials.gov ↗ ← All trials in China