NCT00728403Unknown2 期
Long Term Metabolic and Therapeutic Effects of Combined Treatment of American Ginseng (Panax Quinquefolius L.) Extract and Korean Red Ginseng (Steamed Panax C.A. Meyer) Extract in the Treatment of Type 2 Diabetes
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- HbA1c levels and insulin sensitivity index using 3 different indices: ISI, HOMA, QUICKI
研究概览
简要总结
The study is a 2 phase double blind randomized placebo control trial. The objective is to asses the metabolic and therapeutic effects of American Ginseng (Panax quinquefolius L.) extract and Korean Red Ginseng (steamed Panax C.A. Meyer) extract in the management of type 2 diabetes in a 12 week period. One Hundred and twenty subjects with type 2 diabetes (hyperglycemia key inclusion criteria: HbAlc≥6.5% - ≤ 8.1% ) will participate in the study (36 men and 36 post-menopausal women).
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
- •presence of type 2 diabetes (at least 1 year) as defined by A1c between ≥6.5% and ≤8.1%, at recruitment,
- •treatment with diet or oral hypoglycemic medication be unchanged starting at least 2 months prior to the beginning of the study (at recruitment, week -8)
- •between the age of 40 and 75 years
- •systolic blood pressure <140 and diastolic blood pressure <90
- •clinically euthyroid (measuring T3 and T4)
- •normal renal and liver functions
- •post-menopausal or non-pregnant women (Post-menopausal includes: those females with more than a year of cessation of menstruation)
- •a negative result on a pregnancy test administered at screening
- •subjects taking an effective form of birth control (example: condom, abstinence, etc.)
- •willing to comply with the study protocol and sign a consent form
排除标准
- •individuals with bleeding disorders
- •individuals with allergies to nitroglycerin
- •planned surgery, pregnancy or breastfeeding
- •taking insulin; clinically significant diabetes complications (retinopathy, nephropathy, or neuropathy); serum triglycerides ≥ 4.5 mmol/L
- •increased A1c level of more than 2% from baseline during the study
- •history of angina or heart attack
- •use of ginseng or any natural health products with glucose modulating and/or anti-platelet activity within 2 months
- •BMI > 35 kg/m2 including a weight fluctuation of + 2kg during treatment periods
- •smoke cigarettes; alcohol intake > 2 drinks/day
- •the presence of any conditions which, in the opinion of the investigator, might jeopardize the health and safety of the subject or study personnel or adversely affect the study results, if the subject participated in the study
- •Subjects taking Warfarin or Coumadin, prescription NSAIDs, chronic use of high-dose (>81mg) non-prescription NSAIDs, or selective serotonin reuptake inhibitors and monoamine oxidase inhibitors, or sympathomimetics or medications affecting nitric oxide levels, or any known or suspected sensitivity to any of the ingredients in the test product or placebo cannot participate in the study.
结局指标
主要结局
HbA1c levels and insulin sensitivity index using 3 different indices: ISI, HOMA, QUICKI
时间窗: Weeks -4, 0, 6, 12
次要结局
- Cholesterol, triglycerides, fasting & post-prandial blood glucose and insulin, C-reactive protein, lipid peroxidation, blood pressure, endothelial function, body fat composition(Weeks -4, 0, 6, 12)
研究者
研究点 (2)
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