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

Effect of Huangqi Gegen Decoction on Endothelial Function and Its Mechanisms in Patients With Qi-Yin Deficiency Syndrome and Type 2 Diabetes Mellitus at Very High Risk for Atherosclerotic Cardiovascular Disease

This clinical trial evaluates whether Huangqi Gegen Decoction can improve blood vessel function in adults with type 2 diabetes mellitus who are at very high risk of atherosclerotic cardiovascular disease and meet the traditional Chinese medicine criteria for Qi-Yin deficiency syndrome.

A total of 90 participants are randomly assigned in a 1:1 ratio to receive either Huangqi Gegen Decoction granules or matching placebo granules, in addition to their usual guideline-based treatment, for 12 weeks. Participants and investigators are blinded to treatment assignment.

The main outcome is flow-mediated dilation (FMD), a noninvasive measure of how well blood vessels dilate. The study also evaluates blood glucose control, blood markers related to endothelial function and inflammation, traditional Chinese medicine syndrome scores, and safety.

The investigators hypothesize that Huangqi Gegen Decoction, when added to conventional treatment, will improve endothelial function compared with placebo.

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.