NCT01578837已完成1 期
Efficacy and Safety of Combined Rg3-enriched Korean Red Ginseng (Panax Ginseng C.A. Meyer) and American Ginseng (Panax Quinquefolius) as Poly-therapy in the Management of Concomitant Hypertension in Type 2 Diabetes
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- Change in Mean 24 hour Systolic Ambulatory Blood Pressure at 12 weeks
研究概览
简要总结
The study is a combined Phase-I like (safety) and Phase-II like (efficacy) double blind randomized placebo controlled trial. The objective is to investigate whether the combination of AG and Rg3-enriched Korean Red ginseng added to conventional medical treatment are effective and safe in the long-term management of high blood pressure while managing type 2 diabetes. Eighty-five subjects with type 2 diabetes and concomitant high blood pressure (key inclusion criteria: HbA1c ≥ 6.5%- ≤ 8.0%) will be recruited for the study.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •between the age of 40 and 75 years
- •type 2 diabetes (at least 1 year duration, HbA1c ≥ 6.5%- ≤ 8.0%, treated with diet and/or oral hypoglycemic medications)
- •clinically diagnosed and treated hypertension according to Canadian Diabetes Association Clinical Practice Guidelines
- •normal thyroid, kidney and liver functions
- •female subjects recruited for the study must be post-menopausal or had absence of menstruation for ≥ 1 year or is taking contraceptive precautions
排除标准
- •insulin therapy
- •history of angina, myocardial infarction or stroke
- •systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg
- •use of ginseng within 1 month start of study
- •BMI >35 kg/m2
- •smoking cigarettes
- •alcohol intake of > 2 drinks/day
- •recently given blood
- •have an upcoming planned surgery
- •GFR <60 mL/min/1.73m2
- •prolonged QT (>20 ms) interval as assessed by ECG
- •changes to use of natural health products that may effect blood pressure and/or diabetes
- •weight change more than +/- 3 kg/month
- •HIV infection, inflammatory bowel disease, celiac disease, heart disease, bleeding disorder, sleep disorder, arrhythmia
- •pregnant or breastfeeding
- •use of anticoagulant (excluding aspirin), antiplatelet, sedative, sympathomimetic, photosensitizing or anti-depressant drugs
- •hormone replacement therapy, furosemide, morphine, glucocorticoids
- •presence of any conditions which, in the opinion of the Qualified Investigator, might jeopardize the health and safety of the subject or study personnel, or adversely affect the study results
- •known sensitivity or allergy to any test product or placebo ingredients
研究组 & 干预措施
Wheat Bran
Placebo Comparator
100 % Natural Wheat Bran capsule
干预措施: Wheat Bran (Dietary Supplement)
Ginseng
Experimental
Combined Rg3-enriched Korean Red Ginseng and American Ginseng capsule
干预措施: Ginseng (Dietary Supplement)
结局指标
主要结局
Change in Mean 24 hour Systolic Ambulatory Blood Pressure at 12 weeks
时间窗: 12 Weeks
次要结局
- Change in HbA1c(12 Weeks)
- Change in RHI at 12 weeks(12 weeks)
- Change in Pulse Pressure(12 Weeks)
- Change in Calculated HOMA-Insulin Sensitivity(12 Weeks)
- Change in Central Augmentation Index and pulse wave analysis(12 Weeks)
- Change in Pulse Wave Velocity at 12 Weeks(12 Weeks)
- Change in low-grade body inflammation (hs-CRP)(12 Weeks)
- Change in lipids at 12 weeks(12 weeks)
- Change in Mean 24 hour Diastolic, daytime and nighttime Ambulatory Blood pressure at 12 Weeks(12 Weeks)
- Change in Fasting Insulin(12 Weeks)
- Change in Fasting Glucose(12 Weeks)
研究者
研究点 (4)
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