NCT01005069已完成2 期
Phase-II Clinical Study: A Randomized, Double Blind, Dose Ranging, and Controlled Study to Evaluate the Efficacy of DLBS-32 in Subjects With Type-II Diabetes Mellitus
Dexa Medica Group2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2009年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Reduction of venous Fasting Plasma Glucose from baseline
研究概览
简要总结
The purpose of this study is to investigate clinical efficacy and safety of DLBS 32 in the management of subjects with type-II-diabetes mellitus and to determine the minimal effective dose of DLBS 32 for subjects with type-II-diabetes mellitus.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fasting capillary blood glucose of 127-249 mg/dL at screening
- •BMI >= 18.5 kg/m^2 or waist circumference of >= 90 cm (male) or >= 80 cm (female)
- •Normal liver function
- •Normal renal function
- •OHA-naive type-II-diabetic patients
排除标准
- •Symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
- •Uncontrolled hypertension
- •History of or current treatment with insulin
- •Current treatment with systemic corticosteroids or herbal (alternative) medicines
- •History of renal and/or liver disease
- •Pregnant or breast feeding females
研究组 & 干预措施
Treatment I
Experimental
干预措施: DLBS-32 (Drug)
Treatment II
Experimental
干预措施: DLBS-32 (Drug)
Treatment III
Experimental
干预措施: DLBS-32 (Drug)
Treatment IV
Experimental
干预措施: DLBS-32 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo capsule (Drug)
结局指标
主要结局
Reduction of venous Fasting Plasma Glucose from baseline
时间窗: every 2-week interval over 6 weeks of treatment
次要结局
- Reduction of 2h-post-prandial plasma glucose from baseline(six weeks)
- Change of homeostasis model assessment of insulin resistance (HOMA-IR) from baseline(six weeks)
- Change of high sensitivity C-reactive protein (hs-CRP) from baseline(six weeks)
- Liver Function, Renal Function, Adverse events(six weeks)
- Change in HbA1c from baseline(six weeks)
- Change in lipid profile from baseline(six weeks)
研究者
研究点 (2)
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