This study evaluates the safety and preliminary efficacy of Bletilla formosana (BF), a traditional herbal medicine, in adults with prediabetes. Prediabetes is a high-risk condition where blood sugar levels are elevated, often leading to type 2 diabetes. While lifestyle changes are the standard treatment, researchers are exploring herbal supplements as a complementary way to support metabolic health. Preclinical research has shown that BF possesses anti-inflammatory properties and may help regulate blood glucose. Participants in this study will be randomly assigned to receive either a high dose of BF, a low dose of BF, or a placebo (an inactive substance) for 12 weeks. The total study duration is approximately 24 weeks, involving four clinic visits for blood tests and safety monitoring to see how BF affects blood sugar markers and inflammation.
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-where BF extract was shown to inhibit neutrophil-driven inflammation and improve glycemic parameters 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%) will be 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 Bletilla formosana powder plus 1.5g placebo daily. Placebo group: 3g inactive placebo powder daily. The study consists of three distinct phases: Screening Phase: Up to 2 weeks for eligibility confirmation. Treatment Phase: 12 weeks of oral administration. Follow-up Phase: 12 weeks post-treatment to evaluate sustained efficacy and safety outcomes. Phase I objectives focus on safety and tolerability, with adverse events (AEs) and serious adverse events (SAEs) graded according to CTCAE v5.0. Phase II objectives explore preliminary efficacy through changes in fasting plasma glucose (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, are scheduled at Screening, Week 6, Week 12 (end of treatment), and Week 24 (end of study).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
94
A traditional Chinese medicinal herb (Taiwanese ground orchid). The raw material is derived from the approved botanical species and medicinal part listed in the Taiwan Herbal Pharmacopoeia.
An inactive powder matching the appearance and dosage form of the BF powder, consisting of starch and caramel coloring.
Keelung Chang Gung Memorial Hospital
Keelung, Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan, Taiwan
Taoyuan Chang Gung Memorial Hospital
Taoyuan, Taiwan
Number of Participants with at Least One Treatment-Emergent Adverse Event (AE)
Incidence of all adverse events (AEs) graded by CTCAE v5.0.
Time frame: From baseline to Week 24.
Number of Participants with Serious Adverse Events (SAEs)
Number of participants experiencing life-threatening or fatal events according to ICH-GCP definitions.
Time frame: From baseline to Week 24
Change from Baseline in Fasting Plasma Glucose (FPG) (mg/dL)
Change in fasting blood sugar levels to assess the preliminary glycemic efficacy of Bletilla formosana.
Time frame: Baseline, Week 6, Week 12, and Week 24.
Change from Baseline in Glycated Hemoglobin (HbA1c) (%)
Assessment of average blood glucose control over time.
Time frame: Baseline, Week 6, Week 12, and Week 24.
Change from Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Calculated using fasting insulin and glucose levels to assess changes in insulin sensitivity.
Time frame: Baseline, Week 6, Week 12, and Week 24.
Change from Baseline in Tumor Necrosis Factor-alpha (TNF-α) (pg/mL)
To evaluate the anti-inflammatory effects of Bletilla formosana.
Time frame: Baseline, Week 6, Week 12, and Week 24.
Change from Baseline in Interleukin-6 (IL-6) (pg/mL)
To evaluate the anti-inflammatory effects of Bletilla formosana.
Time frame: Baseline, Week 6, Week 12, and Week 24.
Change from Baseline in C-reactive protein (CRP) (mg/dL)
To evaluate the anti-inflammatory effects of Bletilla formosana.
Time frame: Baseline, Week 6, Week 12, and Week 24.
Change from Baseline in Total Cholesterol (mg/dL)
Assessment of lipid profiles using standard laboratory methods
Time frame: Baseline, Week 6, Week 12, and Week 24.
Change from Baseline in High-Density Lipoprotein (HDL) (mg/dL)
Assessment of lipid profiles using standard laboratory methods.
Time frame: Baseline, Week 6, Week 12, and Week 24.
Change from Baseline in Low-Density Lipoprotein (LDL) (mg/dL)
Assessment of lipid profiles using standard laboratory methods.
Time frame: Baseline, Week 6, Week 12, and Week 24.
Change from Baseline in Triglycerides (TG) (mg/dL)
Assessment of lipid profiles using standard laboratory methods.
Time frame: Baseline, Week 6, Week 12, and Week 24.
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