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临床试验/NCT06002893
NCT06002893已完成不适用

The Antihypercholestrolemic Pharmacological Effect of a Combined Supplement of Amla Fruit, Walnut Leaves, Red Yeast Rice, and Olive Fruit Extracts Leads to Improvement in Circulatory Levels of LDL-C and Remnant Cholesterol

Liaquat University of Medical & Health Sciences1 个研究点 分布在 1 个国家目标入组 221 人开始时间: 2020年3月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
221
试验地点
1
主要终点
Decrease in blood lipid profile

研究概览

简要总结

Nutraceutical lipid-lowering interventions are becoming increasingly popular, particularly among patients who are intolerant or refractory to prescription statins, or who desire alternative non-conventional pharmacological treatment to manage their dyslipidaemia, whether they previously experienced statin intolerance or not. A growing body of preclinical and clinical evidence suggest that the amla (Emblica officinalis) red yeast rice (RYR), olive and walnut leaf extracts posses consideable hpolipidaemic pharmacological effects.

详细描述

The present exploratory study aimed to assess the safety, efficacy, and patient's satisfaction of a combined supplementation of amla, red yeast rice, olive, and walnut leaf extracts (Cholesfytol NG®) on total cholesterol (TC), low-density lipoprotein - cholesterol (LDL-C), high-density lipoprotein - cholesterol (HDL-C), non-high-density lipoprotein - cholesterol (non-HDL-C), remnant cholesterol (RC) and triglycerides (TG) in hyperlipidaemic patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 21 years
  • Both male or female
  • Blood total cholesterol (TC) level ≥ 200 mg/dL
  • Blood low-density lipoprotein cholesterol (LDL-C) level ≥ 130 mg/dL
  • With or without myalgia and/or diabetes
  • No prior treatment of cholesterol-lowering agents and/or patients whose cholesterol- lowering treatment did not allow them to reach LDL-C target
  • Patients who had stopped their cholesterol-lowering treatment because of side effects including myalgia

排除标准

  • Pregnant nor breastfeeding patients

结局指标

主要结局

Decrease in blood lipid profile

时间窗: 2-months

Change in blood remnant cholesterol (RC) concentration

Change in blood lipid profile

时间窗: 2-months

Decrease in blood total cholesterol (TC) concentration

次要结局

  • Rate of side effects(2-months)

研究者

发起方
Liaquat University of Medical & Health Sciences
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Amjad Khan

Professor of Clinical Biochemistry and Experimental Medicine

Liaquat University of Medical & Health Sciences

研究点 (1)

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