Huangqi Gegen Decoction for Endothelial Function in Type 2 Diabetes at Very High ASCVD Risk

Prior treatment

• 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.
• Current use of other medications that may significantly affect systemic immune function.
• 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.

Other illness

• 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.
• History of malignant tumor within the previous 5 years.
• Active infectious disease at screening or randomization, psychiatric illness, pregnancy or breastfeeding, or any other condition considered by the investigator to make participation inappropriate.
• 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.

Other

• 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.

• 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.