A Phase I/II Randomized, Double-Blind, Placebo-Controlled Pilot Trial Evaluating the Safety and Dose-Response of Bletilla Formosana in Prediabetic Subjects
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 94
- 试验地点
- 3
- 主要终点
- Number of Participants with at Least One Treatment-Emergent Adverse Event (AE)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
To ensure blinding, the investigational product (BF powder) and the placebo (starch with caramel coloring) are identically packaged in standardized, light-blocking plastic bottles and labeled only with unique subject codes. All participants receive the same number of sachets (one in the morning and one in the evening) so that the appearance, dosage form, and administration frequency remain indistinguishable across all treatment arms. The randomization code is securely maintained by the Traditional Chinese Medicine Pharmacy and will not be disclosed to investigators or participants until database lock.
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 30-70 years.
- •Prediabetes defined by any of the following:
- •Fasting Plasma Glucose (FPG) of 100-125 mg/dL, or
- •Glycated hemoglobin (HbA1c) of 5.7%-6.4%.
- •Willingness to provide written informed consent and comply with study procedures.
排除标准
- •Established type 1 or type 2 diabetes mellitus, or recent use of oral antidiabetic agents or insulin (within 3 months).
- •Abnormal liver function, defined as Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) exceeding 2-fold the upper reference limit (≥2 × ULN) at screening.
- •Abnormal renal function, defined as serum creatinine (Cr) >1.5 mg/dL or Estimated Glomerular Filtration Rate (eGFR) <60 mL/min/1.73 m².
- •Gastrointestinal disorders that may affect drug absorption, such as gastrostomy, enterostomy, severe chronic diarrhea, or malabsorption syndrome.
- •Severe comorbidities within the past 6 months, including major stroke, myocardial infarction, major trauma, or major surgery.
- •Recent use of medications (within 1 month) that may significantly alter blood glucose or lipids, such as systemic corticosteroids or non-stable doses of lipid-lowering agents.
- •Malignant tumor under active treatment, or immunodeficiency/autoimmune disorders requiring immunosuppressive therapy.
- •Psychiatric disorders or cognitive impairment that may affect protocol compliance.
- •Active use of other investigational drugs within 3 months prior to screening.
- •Pregnancy or lactation.
结局指标
主要结局
Number of Participants with at Least One Treatment-Emergent Adverse Event (AE)
时间窗: From baseline to Week 24.
Incidence of all adverse events (AEs) graded by CTCAE v5.0.
Number of Participants with Serious Adverse Events (SAEs)
时间窗: From baseline to Week 24
Number of participants experiencing life-threatening or fatal events according to ICH-GCP definitions.
Change from Baseline in Fasting Plasma Glucose (FPG) (mg/dL)
时间窗: Baseline, Week 6, Week 12, and Week 24.
Change in fasting blood sugar levels to assess the preliminary glycemic efficacy of Bletilla formosana.
Change from Baseline in Glycated Hemoglobin (HbA1c) (%)
时间窗: Baseline, Week 6, Week 12, and Week 24.
Assessment of average blood glucose control over time.
Change from Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
时间窗: Baseline, Week 6, Week 12, and Week 24.
Calculated using fasting insulin and glucose levels to assess changes in insulin sensitivity.
次要结局
- Change from Baseline in Tumor Necrosis Factor-alpha (TNF-α) (pg/mL)(Baseline, Week 6, Week 12, and Week 24.)
- Change from Baseline in Interleukin-6 (IL-6) (pg/mL)(Baseline, Week 6, Week 12, and Week 24.)
- Change from Baseline in C-reactive protein (CRP) (mg/dL)(Baseline, Week 6, Week 12, and Week 24.)
- Change from Baseline in Total Cholesterol (mg/dL)(Baseline, Week 6, Week 12, and Week 24.)
- Change from Baseline in High-Density Lipoprotein (HDL) (mg/dL)(Baseline, Week 6, Week 12, and Week 24.)
- Change from Baseline in Low-Density Lipoprotein (LDL) (mg/dL)(Baseline, Week 6, Week 12, and Week 24.)
- Change from Baseline in Triglycerides (TG) (mg/dL)(Baseline, Week 6, Week 12, and Week 24.)
研究者
YUAN-CHIEH YEH
Associate Professor / Attending Physician
Chang Gung Memorial Hospital