Efficacy and Safety of Dachaihu Decoction Combined Erzhiwan With Variation for the Treatment of Hypercholesterolemia: A Parallel, Randomized, Double-blinded, Placebo-controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 70
- 主要终点
- The percent change in Low-density lipoprotein-cholesterol (LDL-C) levels
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled clinical trial. Eligible subjects will randomized into a treatment group or placebo group. They will receive either Chinese medicine granules or placebo granules for 8 weeks followed by a 4-week observation period. The primary outcome would be the percent change in Low-density lipoprotein cholesterol levels (LDL-C) after treatment.
详细描述
Hypercholesterolemia refers to a metabolic disease caused by abnormal cholesterol metabolism in the blood cholesterol content exceeding the normal range, which can be mainly divided into total cholesterol (TC) in plasma and low-density lipoprotein cholesterol LDL-C) or a decrease in high-density lipoprotein cholesterol (HDL-C). Uncontrolled hypercholesterolemia is considered an important risk factor for cardiovascular and cerebrovascular diseases.
In recent years, there has been an increasing number of clinical studies of Traditional Chinese Medicine combinations or single herbs for hypercholesterolemia, and some drugs do have cholesterol-lowering effects, but the clinical evidence is not high due to bias or other deficiencies in trial design. Therefore, this clinical trial aim to evaluate the effectiveness of Dachaihu Decoction combined Erzhiwan with variation to the treatment of patients with clinical hypercholesterolemia, and tried to reduce its adverse effects on liver function through reasonable compatibility.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years old, any gender;
- •LDL-C level of 4.1 mmol/L or above (no statin therapy during the screening period);
- •Be able to maintain a more consistent lifestyle and eating habits throughout the study;
- •Have a fixed residence and are not expected to move or travel for 8 weeks;
- •Voluntarily sign the informed consent form.
排除标准
- •Taking drugs that may affect lipid metabolism (such as steroids, sleeping pills, and psychotropic drugs);
- •Alcohol or drug abuse within the last 3 months;
- •Known liver function or renal dysfunction;
- •History of severe cardiovascular and cerebrovascular diseases; or history of psychiatric illness;
- •Participate in other interventional clinical trials within 3 months before the study, including drugs, supplements, medical devices, etc.;
- •Known pregnant or lactating women, allergies or allergies to traditional Chinese medicine;
- •Patients with known secondary hypercholesterolemia.
研究组 & 干预措施
Dachaihu Decoction combined Erzhiwan with variation granules
Chinese medicine granules
干预措施: Dachaihu Decoction combined Erzhiwan with variation (Drug)
Placebo granules
Placebo granules
干预措施: Placebo granules (Other)
结局指标
主要结局
The percent change in Low-density lipoprotein-cholesterol (LDL-C) levels
时间窗: 8 weeks
Compare the percent change in LDL-C levels from baseline to week 8
次要结局
- The percent change in Low-density lipoprotein-cholesterol (LDL-C) levels(12 weeks)
- The level of Low-density lipoprotein-cholesterol (LDL-C)(12 weeks)
- The percent change in High-density lipoprotein-cholesterol (HDL-C) level(12 weeks)
- The level of High-density lipoprotein-cholesterol (HDL-C)(12 weeks)
- The percent change in Total cholesterol (TC) level(12 weeks)
- The level of Total cholesterol (TC)(12 weeks)
- The percent change in Triglycerides (TG)(12 weeks)
- The level of Triglycerides (TG)(12 weeks)
- Proportion of patients' LDL-c below 70 mg/L(12 weeks)
- The percent change in Low-density lipoprotein-cholesterol (LDL-C) levels(4 weeks)
- The level of Low-density lipoprotein-cholesterol (LDL-C)(4 weeks)
- The level of Low-density lipoprotein-cholesterol (LDL-C)(8 weeks)
- The percent change in High-density lipoprotein-cholesterol (HDL-C) level(4 weeks)
- The percent change in High-density lipoprotein-cholesterol (HDL-C) level(8 weeks)
- The level of High-density lipoprotein-cholesterol (HDL-C)(4 weeks)
- The level of High-density lipoprotein-cholesterol (HDL-C)(8 weeks)
- The percent change in Total cholesterol (TC) level(4 weeks)
- The percent change in Total cholesterol (TC) level(8 weeks)
- The level of Total cholesterol (TC)(4 weeks)
- The level of Total cholesterol (TC)(8 weeks)
- The percent change in Triglycerides (TG)(4 weeks)
- The percent change in Triglycerides (TG)(8 weeks)
- The level of Triglycerides (TG)(4 weeks)
- The level of Triglycerides (TG)(8 weeks)
- Proportion of patients' LDL-c below 70 mg/L(8 weeks)
研究者
Prof. Lin Zhixiu
Professor
Chinese University of Hong Kong