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

This is a single‐center, randomized, double‐blind, placebo‐controlled clinical trialconducted at Putuo Hospital, Shanghai University of Traditional Chinese Medicine.Eligible participants are adults aged 18 to 75 years with type 2 diabetes mellitus, veryhigh risk of atherosclerotic cardiovascular disease, and Qi‐Yin deficiency syndromeaccording to traditional Chinese medicine criteria. Participants are randomly assigned ina 1:1 ratio to the experimental group or the placebo control group.Both groups continue stable conventional treatment for diabetes and cardiovascular riskmanagement. The experimental group receives Huangqi Gegen Decoction granules in additionto conventional treatment, while the control group receives matching placebo granules inaddition to conventional treatment. The intervention period is 12 weeks. The studymedication and placebo are designed to have similar appearance, packaging, andadministration, and participants and investigators remain blinded to treatmentassignment.Participants are assessed at baseline and followed during the 12‐week treatment period.Flow‐mediated dilation is assessed as the primary measure of endothelial function.Additional assessments include glucose metabolism, biomarkers related to endothelialfunction and inflammation, traditional Chinese medicine syndrome scores, and safetyoutcomes. Adverse events and concomitant medications are monitored throughout the study.The study is designed to determine whether adding Huangqi Gegen Decoction to conventionaltreatment provides additional improvement in endothelial function and related clinicalmeasures compared with conventional treatment plus placebo.