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临床试验/ACTRN12623000534684
ACTRN12623000534684已完成3 期

Hypolipidemic effects of a novel neutracheutical containing monacolin K, combined with coenzyme Q10, policosanols, Bergamot and thistle extract in patients with mild dyslipidemia.

icholaos Angelopoulos,MD,Phd0 个研究点目标入组 80 人开始时间: 2023年5月19日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
80

研究概览

简要总结

Asignificant median reduction of 13.25% in LDL-C levels was achieved in the treated group and no adverse effects were reported.

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
40 Years 至 80 Years(—)
性别
All

入选标准

  • Patients are eligible to participate in the present study if they have mild hypercholesterolemia (fasting LDL-C concentration between 140 and 180 mg/dL) and no indication for statin treatment [10-year atherosclerotic cardiovascular disease risk (ASCVD Risk) < 7.5%]. The 10-year risk wil be calculated in all participants using the updated ASCVD Risk Estimator Plus (found in: https://tools.acc.org/ASCVD-Risk-Estimator-Plus/#!/calculate/estimate

排除标准

  • Use of lipid-lowering medications, such as statins, within 3 months prior to study enrollment, conditions which produce an increased ASCVD risk, such as diabetes mellitus, known atherosclerotic vascular disease, or moderate/severe renal insufficiency (Modification of Diet in Renal Disease calculated glomerular filtration rate, MDRD GFR < 60 mL/min), abnormal liver function tests, excessive alcohol intake, pregnancy, lactation or the use of oral contraceptives

研究者

发起方
icholaos Angelopoulos,MD,Phd

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