NCT01120873已完成3 期
Phase 3 Study of 3D in Metabolic Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Total cholesterol
研究概览
简要总结
To evaluate the effect of Metamin 3D on improvement of glucose and lipid on Taiwanese subjects with metabolic syndrome.
详细描述
The Metamin 3D consists of mixed extractives of nature plants, including soy bean protein, bitter melon, red yeast rice, green algae and trisodium glycyrrhizinate. the improvement of lipid and glucose was reported respectively previously. We design a prospective, double-blinded and placebo-controlled study to evaluate the improvement on metabolic syndrome.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 30 and 75 years
- •Fasting plasma glucose >= 100 mg/dl
- •Triglyceride >= 150 mg/dl
- •one of the criteria following
- •HDL <40 mg/dl in man or <50 mg/dl in woman
- •Blood pressure >= 135/85 mmHg or anti-hypertension drug treatment
- •Waist >90cm in man or 80cm in woman
- •Signed the inform consent
排除标准
- •Fasting plasma glucose > 180mg/dl
- •Treated by more than two types oral hypoglycemic agents in past 3 months
- •Treated continuously by anti-lipid agents for 3 months in past 6 months
- •Treated by thiazolidinedione or digitalis at present
- •Serum creatine > 2.5mg/dl
- •Liver function (GOT or GPT) more than 3-fold upper limit
- •Severe systemic disease by investigator's judgement
- •Pregnant or nursing women
- •Enrolled in other clinical study in recent 1 month
研究组 & 干预措施
Metamin 3D
Experimental
A randomized, double-blinded and placebo-controlled study
干预措施: Metamin 3D (Drug)
结局指标
主要结局
Total cholesterol
时间窗: 12 weeks
To assess the change of total cholesterol between 0 and 12 weeks
次要结局
- Total cholesterol(4 and 8 weeks)
- Triglycerides(12 weeks)
- Low-density lipoprotein cholesterol(4, 8 and 12 weeks)
- The plasma insulin by meal tolerant test(4 and 8 weeks)
- Glycosylated hemoglobin(12 weeks)
- Fasting plasma glucose(12 weeks)
- Systolic and diastolic blood pressure(4, 8 and 12 weeks)
- The plasma glucose by meal tolerant test(12 weeks)
- Aspartate aminotransferase(12 weeks)
- Alanine aminotransferase(12 weeks)
- Creatinine(12 weeks)
研究者
研究点 (1)
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