CTRI/2013/06/003786已完成未知
A randomized double blinded placebo controlled clinical trial to assess the tolerability and efficacy of Lycq® on cholesterol and lipoproteins in subjects with moderately elevated serum cholesterol levels
Edio Healthcare AB0 个研究点目标入组 80 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 80
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
入选标准
- •Healthy as assessed by screening laboratory tests
- •Age 25 to 70
- •Total serum cholesterol level > 5.2 mmol/l, <7.0 mmol/
- •Normal liver, kidney and thyroid function
- •Signed written informed consent
排除标准
- •Participation in a clinical study 30 days prior to screening visit
- •Established /diagnosed phytosterolemia
- •Hypersensitivity towards any of the excipients
- •Consumption of cholesterol lowering medication 1 month prior to screening visit and throughout the study
- •Slimming or medically prescribed diet/prescription to special diet (vegan/gluten-free)
- •Alcohol or substance abuse (More than1 to 2 Drinks for Female and 2to 4 drinks for Males per day), within 6 months prior to or under the study.
- •History of unstable coronary artery disease within the previous 6 months
- •Transient Ischemic Attack (TIA) within 1 year prior to screening
- •Hyper-/hypo-thyroidism
- •Malignant disease, treatment ended less than 12 months prior to study start.
- •Pregnant or attempting to become pregnant or lactating during any period of the study
- •Lack of suitability for participation in the trial, for any reason, as judged by staff at the Investigating party
研究者
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