Efficacy and Safety of American Ginseng (Penax Quinquefolius) Extract on Glycemic Control in Individuals With Type 2 Diabetes: A Double-blind, Randomized, Crossover Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- HbA1c
研究概览
简要总结
Objective: We aim to evaluate longer term efficacy and safety of AG as an add-on therapy in patients with type 2 diabetes controlled by conventional treatment. Materials and Methods: A total of 23 type 2 patients are enrolled in the study. Utilizing a double-blind, crossover design, the participants are randomized to receive either placebo or American ginseng extract (AG) 1g/meal=3g/day for 8-week, while maintained on their conventional diabetes treatment. Following ≥4-week washout period the participants are crossed over to another 8-week treatment arm. Throughout the study period, all individuals maintain their original diabetes treatment and regular lifestyle. The primary endpoint is HbA1c, and secondary are fasting blood glucose and insulin, blood pressure, serum nitrates/nitrites (NOx) and PAI-1. Safety parameters include liver, kidney and hemostatic functions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of type 2 diabetes of ≥1 year duration
- •BMI between 25-35kg/m^2
- •HbA1c between 6.5-8.5%
排除标准
- •Patients on insulin therapy
- •Impaired hepatic or renal function
- •Clinically manifested diabetic complications
- •Present cardiac problems
- •Uncontrolled hypoglycemia
- •Cigarette smokers
- •Alcohol consumption (>2 drinks per week)
- •Taking ginseng or other herb with possible hypoglycemic effect
- •Involvement in any other investigational drug studies
- •Changed medication during the course of the study periods or during the washout period
结局指标
主要结局
HbA1c
时间窗: 8 weeks
次要结局
- Fasting blood insulin(8 weeks)
- Plasminogen activator inhibitor-1 (PAI-1)(8 weeks)
- serum creatinine(8 weeks)
- Fasting blood glucose(8 weeks)
- Blood pressure(8 weeks)
- serum nitrates/nitrites (NOx)(8 weeks)
- Alanine amino-transferase (ALT)(8 weeks)