YJP-14 Capsules for the Treatment of Endothelial Dysfunction in Patients With Diabetes Mellitus
Multicenter, Randomized, Double Blind, Placebo-controlled, Phase II Clinical Trial to Evaluate the Safety and Efficacy of YJP-14 Capsules for the Treatment of Endothelial Dysfunction in Patients With Diabetes Mellitus
研究概览
详细说明
The primary purpose of this study is to demonstrate superior effect of YJP-14 three doses, 25, 50 and 100 mg t.i.d on endothelial dysfunction in diabetes mellitus indicated as mean change difference of flow-mediated dilation (FMD), compared to placebo group after treatment of 12 weeks.
The secondary purposes of this study are divided into three as follows;
- Clinically significant effect of YJP-14 three doses, 25, 50 and 100 mg t.i.d on endothelial dysfunction in diabetes mellitus indicated as mean change difference of FMD, compared to placebo group after treatment of 8 weeks.
- Clinically significant effect of YJP-14 three doses, 25, 50 and 100 mg t.i.d on insulin resistance in diabetes mellitus indicated as mean change difference of Homeostasis Model Assessment-Insulin Resistance (HOMA-IR), compared to placebo group after treatment of 4, 8 and 12 weeks.
- Clinically significant effect of YJP-14 three doses, 25, 50 and 100 mg t.i.d on mean change difference of blood pressure in diabetes mellitus, compared to placebo group after treatment of 4, 8 and 12 weeks.
The exploratory purposes of this study are divided into two as follows;
- Clinically significant effect of YJP-14 three doses, 25, 50 and 100 mg t.i.d on blood glucose level in diabetes mellitus indicated as mean change difference of HbA1c, compared to placebo group after treatment of 12 weeks.
- Clinically significant effect of YJP-14 three doses, 25, 50 and 100 mg t.i.d on vascular stiffness in diabetes mellitus indicated as mean change difference of blood lipids (LDL, HDL and TG), compared to placebo group after treatment of 12 weeks.
研究类型
注册 (预期的)
阶段
- 阶段2
联系人和位置
学习地点
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Seoul、大韩民国、110-744
- Internal medicine, Seoul National University Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
Adult-onset DM (defined as fasting glucose greater than 125 mg/dl or by ongoing treatment with an oral hypoglycemic agent), Endothelial dysfunction: FMD below 6.7%, LDL cholesterol level less than 140 mg/dl, Patients agreed to Informed Consent Form
Exclusion Criteria: (Key exclusion criteria) Uncontrolled arterial hypertension (above 139/90 mmHg) or hypotension (below 80/50 mmHg), Severe diabetic complication: diabetic nephropathy, diabetic neuropathy, diabetic retinopathy, diabetic vascular complications
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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安慰剂比较:Placebo t.i.d.
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An 50% ethanolic extract of Lindera obtusiloba stems
其他名称:
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安慰剂比较:YJP-14 25 mg t.i.d.
YJP-14 25 mg t.i.d.
YJP-14 is a 50% ethanolic extract of Lindera obtusiloba stems.
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An 50% ethanolic extract of Lindera obtusiloba stems
其他名称:
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安慰剂比较:YJP-14 50 mg t.i.d.
YJP-14 50 mg t.i.d.
YJP-14 is a 50% ethanolic extract of Lindera obtusiloba stems.
|
An 50% ethanolic extract of Lindera obtusiloba stems
其他名称:
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安慰剂比较:YJP-14 100 mg t.i.d.
YJP-14 is a 50% ethanolic extract of Lindera obtusiloba stems.
YJP-14 100 mg t.i.d.
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An 50% ethanolic extract of Lindera obtusiloba stems
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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Flow-mediated dilation (FMD)
大体时间:12 weeks
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12 weeks
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次要结果测量
结果测量 |
大体时间 |
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Flow-mediated dilation (FMD) Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) Systolic and Diastolic Blood Pressure
大体时间:8 weeks
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8 weeks
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Homeostasis model assessment-insulin resistance (HOMA-IR)
大体时间:4, 8, 12 weeks
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4, 8, 12 weeks
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Systolic and Diastolic Blood Pressure
大体时间:4, 8, 12 weeks
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4, 8, 12 weeks
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其他结果措施
结果测量 |
大体时间 |
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HbA1c Serum lipids (LDL, HDL and TG)
大体时间:12 weeks
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12 weeks
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Serum Lipids (LDL, HDL and TG)
大体时间:12 weeks
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12 weeks
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合作者和调查者
调查人员
- 首席研究员:Byung-Hee Oh, M.D., Ph.D.、Seoul National University Hospital
出版物和有用的链接
一般刊物
- Lee JO, Oak MH, Jung SH, Park DH, Auger C, Kim KR, Lee SW, Schini-Kerth VB. An ethanolic extract of Lindera obtusiloba stems causes NO-mediated endothelium-dependent relaxations in rat aortic rings and prevents angiotensin II-induced hypertension and endothelial dysfunction in rats. Naunyn Schmiedebergs Arch Pharmacol. 2011 Jun;383(6):635-45. doi: 10.1007/s00210-011-0643-9. Epub 2011 May 2.
- Lee JO, Auger C, Park DH, Kang M, Oak MH, Kim KR, Schini-Kerth VB. An ethanolic extract of Lindera obtusiloba stems, YJP-14, improves endothelial dysfunction, metabolic parameters and physical performance in diabetic db/db mice. PLoS One. 2013 Jun 3;8(6):e65227. doi: 10.1371/journal.pone.0065227. Print 2013.
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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YJP-14的临床试验
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Robert Jones and Agnes Hunt Orthopaedic and District...Smith & Nephew, Inc.招聘中
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Centers for Disease Control and PreventionInternational Centre for Diarrhoeal Disease Research, Bangladesh完全的