Chronic Coronary Syndrome Complicated with Type 2 Diabetes Mellitus
Conditions
Interventions
Chuanzhi Qingyu Formula Treatment Group:Chuanzhi Qingyu Formula Granules
Sponsors
China Academy of Traditional Chinese Medicine, Xiyuan Hospital
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Age 40-75 years (inclusive), regardless of gender; (2) Meeting diagnostic criteria for type 2 diabetes mellitus; (3) Meeting diagnostic criteria for chronic coronary syndrome; (4) Meeting TCM syndrome criteria for "intermingled blood stasis and toxin"; (5) HbA1c remains between 6.5%-8.0% after =3 months of standard hypoglycemic treatment; (6) Voluntary participation with signed informed consent.
Exclusion criteria
Exclusion criteria: (1) Comorbid structural or severe functional heart diseases including but not limited to: severe valvular heart disease, obstructive hypertrophic cardiomyopathy, acute myocarditis, cardiogenic shock, severe heart failure (NYHA class III-IV or Killip class III-IV), dilated cardiomyopathy, uncontrolled hypertension (SBP=180mmHg or DBP=110mmHg); (2) Severe arrhythmias requiring intervention (e.g., sustained ventricular tachycardia, atrial fibrillation with rapid ventricular rate unresponsive to medication, high-grade AV block); (3) Acute coronary syndrome (ACS) within 3 months prior to enrollment or history of PCI/CABG; (4) Comorbid autoimmune diseases, malignancies with radio/chemotherapy, thyroid/parathyroid diseases, hematological disorders; (5) Significant hepatic impairment within 6 months (ALT or AST =3×ULN); (6) Pregnant or lactating women; (7) Allergy or contraindications to study drugs/components; (8) Participation in other clinical trials within 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seattle Angina Questionnaire Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting Blood Glucose;Fasting Insulin;Insulin Resistance Index;Troponin T;NT-proBNP;Carotid Intima-Media Thickness;Canadian Cardiovascular Society (CCS) Angina Classification;Weekly Angina Attack Frequency Record;Triglyceride;Total Cholesterol;Low-density lipoprotein cholesterol;High-density lipoprotein cholesterol;glycated hemoglobin; | — |
Countries
China
Contacts
Public ContactZhang Yan
China Academy of Traditional Chinese Medicine, Xiyuan Hospital
Outcome results
None listed