A Randomized, Double-Blind, Placebo-Controlled Cross-Over Study to Evaluate the Safety, Lipid-Lowering Effect and Hypotensive Effect of Shanzha Fruit Drink in Patients With Mild to Moderate Hyperlipidemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- To evaluate the safety of Shanzha Fruit drink in patients with hyperlipidemia by monitoring of liver function tests.
研究概览
简要总结
This is a single-center, randomized, double-blind, placebo-controlled, cross-over study. Subjects who meet the inclusion/exclusion criteria will be randomly and alternatively assigned to receive Shanzha fruit drink or placebo drink in the first 2 months or the last two months of the 5 months study period. In between the first and second treatment period, all patients will enter a Washout Period of 4 weeks and during which time patients should not receive any of the study functional fruit drink.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Total Cholesterol between 200-300 mg/dl (5.2-7.8 mmol/l).
- •Mean plasma triglyceride >= 4.5 mmol/l.
- •Diastolic blood pressure 95-100 mm Hg and/or Systolic blood pressure 130-150 mm Hg.
- •Be able to give written informed consent prior to study start and comply with study requirements.
排除标准
- •• Total Cholesterol between 200-300 mg/dl (5.2-7.8 mmol/l).
- •Mean plasma triglyceride < 4.5 mmol/l.
- •Diastolic blood pressure 95-100 mm Hg and/or Systolic blood pressure 130-150 mm Hg.
- •Be able to give written informed consent prior to study start and comply with study requirements.
结局指标
主要结局
To evaluate the safety of Shanzha Fruit drink in patients with hyperlipidemia by monitoring of liver function tests.
时间窗: 5 months.
Alanine transaminase (ALT) levels as the main liver function test will be measured at the start and the end of the study.
To evaluate the hypolipidemic effect of Shanzha Fruit drink in patients with hyperlipidemia
时间窗: 5 months.
The lipid profile including total cholesterol, HDL cholesterol, LDL-cholesterol and triglycerides will be measured at the start and the end of the study and changes from the baseline to the end of the treatment will be evaluated.
次要结局
- To evaluate the safety of Shanzha Fruit drink in patients with hyperlipidemia by recording any adverse events reported by the study subjects or noted by the investigator.(5 months.)
- To evaluate the hypotensive effect of Shanzha Fruit Drink(5 months.)
研究者
Brian Tomlinson
Professor
Chinese University of Hong Kong