A Randomized, Multi-centre, Double-blind and Placebo Controlled Clinical Study of the Propionyl-L-carnitine Hydrochloride Tablets
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 239
- 试验地点
- 1
- 主要终点
- To compare the difference between pre-and post-the treatment of each group
研究概览
简要总结
The main objective of this study is to evaluate the effectiveness and safety of the propionyl-L-carnitine hydrochloride tablets among Chinese population in comparison with the placebo, for treatment of the peripheral arterial diseases (intermittent claudication) with oral supplementation of 2g daily for a 4 months continuous administration.
详细描述
This is a randomized, multi-centre, double-blind and placebo controlled clinical study. Propionyl-L-Carnitine (PLC) is a kind of natural derivative of L-Carnitine (LC) and is produced in the body and concentrated by 90% in the skeletal muscle and myocardium via an enzyme-mediated reaction involving propionyl-CoA and LC. For oral adminsitration, PLC shows that the decrease of the leg muscle carnitine of the PAD patient appears to correlate with poor exercise performance. It has recently been shown that the severity of the impairment in walking distance is correlated with the impairment in carntine metabolism at the muscle level. 2g daily of PLC supplementation can significantly improve the walking ability in patients with IC with a maximum walking capacity between 50 and 250 meters on the treadmill.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The variability between the two standardized claudication tests during the wash-out period must be <20%, as assessed by the formular: (Highest MWD-Lowest MWD)/(Lowest MWDxx100%)
- •At the last visit during the wash-out period, the ABI at rest must be ,0.9
排除标准
- •with rest pain, ulceration, and/or gangrene
- •PAD of a non-atherosclerotic nature
- •Aortic or lower extremity arterial surgery, angioplasty, or lumbar sympathectomy within 6 months; any above ankle level amputation. Any type of major surgery during the last three months.
- •Except PAD, any concomitant disease that can limit patients' performance in the treadmill exercise.
- •with angina (at rest or activity) or any symptom which is sufficiently severe to discontinue the treadmill exercises.
- •Myocardial infarction within 6 months
- •Severe cerebral dysfunction
- •Type I diabetes (Stable type II diabetes can also be included)
- •alcohol or drug abused history within 3 months
- •Medium or severe anaemia (Hb,90g/L)
- •Platelets <100 x 10 9/L
- •Bleeding diathesis
- •Renal insufficiency or hepatic function laboratory test result>1.5 normal value
- •Treatment with LC or carnitien derivatives in the past 3 months
- •Pregnancy, lactation, fertility without adequate protest against pregnancy
- •Reject to sign the informed consent form
结局指标
主要结局
To compare the difference between pre-and post-the treatment of each group
时间窗: 4 months
次要结局
- Statistically describe the variance of ABI, CT and other indexes at the end of 4th month(4 months)