Safety and Dose-Response of Bletilla Formosana in Prediabetic Subjects

This is a single‐center, Phase I/II, randomized, double‐blind, placebo‐controlled,parallel‐design trial. The primary goal is to translate robust preclinical findings‐whereBF extract was shown to inhibit neutrophil‐driven inflammation and improve glycemicparameters in animal models‐into clinical evidence.A total of 94 prediabetic subjects (defined by FPG 100‐125 mg/dL or HbA1c 5.7%‐6.4%) willbe enrolled.Participants will be randomized in a 2:2:1 ratio into one of the following three arms:High‐dose group: 3g Bletilla formosana powder daily. Low‐dose group: 1.5g Bletillaformosana powder plus 1.5g placebo daily. Placebo group: 3g inactive placebo powderdaily.The study consists of three distinct phases:Screening Phase: Up to 2 weeks for eligibility confirmation. Treatment Phase: 12 weeks oforal administration. Follow‐up Phase: 12 weeks post‐treatment to evaluate sustainedefficacy and safety outcomes.Phase I objectives focus on safety and tolerability, with adverse events (AEs) andserious adverse events (SAEs) graded according to CTCAE v5.0.Phase II objectives explore preliminary efficacy through changes in fasting plasmaglucose (FPG), HbA1c, and HOMA‐IR.Secondary endpoints include assessment of inflammatory biomarkers (TNF‐α, IL‐6, and CRP)and lipid profiles.Clinical assessments, including 12‐lead ECG and comprehensive laboratory testing, arescheduled at Screening, Week 6, Week 12 (end of treatment), and Week 24 (end of study).