NL-OMON43867已完成不适用
Beneficial effects of the amino-acid food supplement L-Citrulline in Participants with Peripheral artery disease - CIPER
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* 40 years or older males and postmenopausal women;
- •* male participants must agree to using an adequate form of contraception during the study period;
- •* 6-month history of stable intermittent claudication (IC) due to PAD;
- •* PAD secondary to atherosclerosis with significant claudication (Fontaine class II defined as IC, or Fontaine class III defined as pain at rest);
- •* IC characterised by pain, ache, cramp, numbness or severe fatigue involving muscles of one or both lower extremities, reproducibly provoked by walking and relieved by rest;
- •* ankle-brachial index (ABI) at rest of <0.9 and at least 25% decrease in ABI within 1 min during exercise recovery;
- •* capacity to walk more than 2 min/15 meters but no more than 12 min on a treadmill using the Skinner-Gardner protocol;
- •* walking limited by claudication, not coexisting conditions; and
- •* difference between two consecutive baseline exercise treadmill tests of <25% during the 3-weeks run-in period; and
- •* no change in medications or physical activity within 3 months prior to enrolment.
排除标准
- •* Women of child-bearing potential;
- •* Current enrolment in another clinical trial and/or ingestion of another investigational product within the past 30 days before enrolment;
- •* PAD of non-atherosclerotic nature;
- •* Fontaine class IV i.e. ulcer or gangrene;
- •* leg amputation above the ankle;
- •* peripheral vascular surgery, sympathectomy, peripheral angioplasty or stent insertion within the previous 3 months;
- •* myocardial infarction, unstable angina, percutaneous transluminal coronary angioplasty or coronary artery bypass graft surgery within the previous 3 months;
- •* uncontrolled hypertension (resting SBP >190 or DBP >115 mmHg);
- •* hypotension (SBP <90mmHg);
- •* type I diabetes, proliferative retinopathy;
- •* history of disease state or surgery that affects gastrointestinal absorption;
- •* significant renal disease (serum creatinine >3.0 mg/dl);
- •* liver disease (transaminase > 3x upper limit of normal, bilirubin >1.5 times upper limits of normal);
- •* history of treatment for any malignancy within the past 5 years, or evidence of active malignancy other than squamous cells or basal cell carcinoma of the skin;
- •* serious infection or hypotension associated with sepsis in the last month;
- •* cerebrovascular infarct in the last 3 months;
- •* autoimmune disorders (e.g. systemic lupus erythematosis, ulcerative colitis);
- •* any other acute or chronic medical condition that in the opinion of the investigators increases the likelihood that the participant would be unable to complete the study;
- •* unwillingness to discontinue arginine- or L-citrulline-containing products, pentoxifylline, L-carnitine, or prostacyclin for at least 1 month prior to and during the study; and
- •* conditions other than PAD that limit walking distance.
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