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【ChiCTR-TRC-14004215】丹參葛根膠囊治療間隔性跛行伴外周動脈疾病的臨床研究

基本信息
登记号

ChiCTR-TRC-14004215

试验状态

尚未开始

药物名称

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药物类型

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规范名称

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首次公示信息日的期

2014-01-28

临床申请受理号

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靶点

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适应症

Intermittent Claudication in Patients with Peripheral Arterial Disease

试验通俗题目

丹參葛根膠囊治療間隔性跛行伴外周動脈疾病的臨床研究

试验专业题目

丹參葛根膠囊治療間隔性跛行伴外周動脈疾病的臨床研究

申办单位信息
申请人联系人
申请人名称
联系人邮箱
联系人邮编

联系人通讯地址
临床试验信息
试验目的

To determine a novel Treatment of Intermittent Claudication in Patients with Peripheral Arterial Disease Using Traditional Chinese Medicine.

试验分类
试验类型

随机平行对照

试验分期

Ⅳ期

随机化

RCT

盲法

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试验项目经费来源

Health Medical Research Fund

试验范围

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目标入组人数

226

实际入组人数

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第一例入组时间

2014-07-04

试验终止时间

1990-01-01

是否属于一致性

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入选标准

Men and women 40 years or older; at least 3-month history of stable IC (Rutherford class 2 or 3) secondary to lower extremity PAD; PAD defined as resting ABI <0.90 in at least 1 limb and a >=10mmHg decrease in ankle artery blood pressure after exercise. In patients with non-compressible vessels (ABI >1.50), the toe–brachial index (TBI) at rest has to be <0.70; Reproducible walking distances with <25% variance between 2 baseline treadmill tests and who terminated all screening treadmill tests solely because of IC pain;

排除标准

Critical limb ischemia defined by ischemic rest pain, ulceration, or gangrene (Rutherford class >=4); Major lower limb amputation (above or below knee amputation); Surgical or endovascular revascularization for PAD within 3 months; Exercise limitation due to significant concomitant disease (e.g. severe hip or knee arthritis, coronary artery disease, heart failure, chronic obstructive airway disease); Concomitant anticoagulation therapy (e.g. warfarin); Pregnancy or breastfeeding; Unable to complete the screening and follow-up treadmill protocols.;

研究者信息
研究负责人姓名
试验机构

Department of Medicine & Therapeutics, The Chinese University of Hong Kong

研究负责人电话
研究负责人邮箱
研究负责人邮编

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联系人通讯地址
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