Clinical Research Directory

Inclusion Criteria: * Aged 18 to 75 years. * Diagnosed with type 2 diabetes mellitus, with fasting plasma glucose \<9.0 mmol/L and glycated hemoglobin (HbA1c) \<8.5%, and receiving a stable glucose-lowering treatment regimen without adjustment during the previous 3 months. * Type 2 diabetes mellitus with target-organ damage or at least 3 additional cardiovascular risk factors. * Meets the diagnostic criteria for Qi-Yin deficiency syndrome in traditional Chinese medicine, including: (a) primary symptoms of dry mouth and thirst, palpitations, and shortness of breath; (b) secondary symptoms including spontaneous sweating, fatigue, chest tightness, chest discomfort or pain, heat sensation in the palms and soles, polyuria, or constipation; and (c) dark-red tongue and weak, thready pulse. The diagnosis requires at least 2 primary symptoms together with supporting secondary symptoms and tongue/pulse findings, and must be confirmed by at least 2 traditional Chinese medicine physicians at attending-physician level or above. * Voluntarily participates in the study and provides written informed consent. * Has received stable conventional treatment for at least 3 months before enrollment, with the treatment regimen consistent with relevant Chinese clinical guidelines for diabetes and chronic coronary syndromes. Exclusion Criteria: * Allergy to the traditional Chinese medicines used in the study or a history of multiple drug allergies. * History of severe arrhythmia, including recurrent or symptomatic ventricular tachycardia or atrial fibrillation with rapid ventricular response, or New York Heart Association (NYHA) functional class III-IV heart failure. * Abnormal thyroid function, including hyperthyroidism or hypothyroidism, defined as thyroid-stimulating hormone below the lower limit of normal or greater than 1.5 times the upper limit of normal. * History of malignant tumor within the previous 5 years. * Major surgery within the previous 3 months or planned major surgery during the study period. * Long-term or repeated use of systemic glucocorticoids within the previous 3 months. * Active infectious disease at screening or randomization, psychiatric illness, pregnancy or breastfeeding, or any other condition considered by the investigator to make participation inappropriate. * Current use of other medications that may significantly affect systemic immune function. * Acute infection or an active inflammatory condition, such as a respiratory tract infection or recent surgery. * Hematologic disorders that may affect immune or inflammatory markers, including chronic myeloid leukemia, idiopathic thrombocytopenic purpura, or aplastic anemia. * Current use of long-acting nitrates or other medications that may affect vasodilatory function. * Use of other traditional Chinese medicine preparations or dietary supplements with known anti-inflammatory or antioxidant effects, such as curcumin or coenzyme Q10, within 1 month before screening.