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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
70
Chinese medicine granules
Placebo granules
The percent change in Low-density lipoprotein-cholesterol (LDL-C) levels
Compare the percent change in LDL-C levels from baseline to week 8
Time frame: 8 weeks
The percent change in Low-density lipoprotein-cholesterol (LDL-C) levels
Compare the percent change in LDL-C levels from baseline to week 4
Time frame: 4 weeks
The percent change in Low-density lipoprotein-cholesterol (LDL-C) levels
Compare the percent change in LDL-C levels from baseline to week 12
Time frame: 12 weeks
The level of Low-density lipoprotein-cholesterol (LDL-C)
The level of LDL-C at week 4
Time frame: 4 weeks
The level of Low-density lipoprotein-cholesterol (LDL-C)
The level of LDL-C at week 8
Time frame: 8 weeks
The level of Low-density lipoprotein-cholesterol (LDL-C)
The level of LDL-C at week 12
Time frame: 12 weeks
The percent change in High-density lipoprotein-cholesterol (HDL-C) level
Compare the percent change in HDL-C levels from baseline to week 4
Time frame: 4 weeks
The percent change in High-density lipoprotein-cholesterol (HDL-C) level
Compare the percent change in HDL-C levels from baseline to week 8
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Time frame: 8 weeks
The percent change in High-density lipoprotein-cholesterol (HDL-C) level
Compare the percent change in HDL-C levels from baseline to week 12
Time frame: 12 weeks
The level of High-density lipoprotein-cholesterol (HDL-C)
The level of HDL-C at week 4
Time frame: 4 weeks
The level of High-density lipoprotein-cholesterol (HDL-C)
The level of HDL-C at week 8
Time frame: 8 weeks
The level of High-density lipoprotein-cholesterol (HDL-C)
The level of HDL-C at week 12
Time frame: 12 weeks
The percent change in Total cholesterol (TC) level
Compare the percent change in TC levels from baseline to week 4
Time frame: 4 weeks
The percent change in Total cholesterol (TC) level
Compare the percent change in TC levels from baseline to week 8
Time frame: 8 weeks
The percent change in Total cholesterol (TC) level
Compare the percent change in TC levels from baseline to week 12
Time frame: 12 weeks
The level of Total cholesterol (TC)
The level of HDL-C at week 4
Time frame: 4 weeks
The level of Total cholesterol (TC)
The level of HDL-C at week 8
Time frame: 8 weeks
The level of Total cholesterol (TC)
The level of HDL-C at week 12
Time frame: 12 weeks
The percent change in Triglycerides (TG)
Compare the percent change in TC levels from baseline to week 4
Time frame: 4 weeks
The percent change in Triglycerides (TG)
Compare the percent change in TC levels from baseline to week 8
Time frame: 8 weeks
The percent change in Triglycerides (TG)
Compare the percent change in TC levels from baseline to week 12
Time frame: 12 weeks
The level of Triglycerides (TG)
The level of Triglycerides (TG) at week 4
Time frame: 4 weeks
The level of Triglycerides (TG)
The level of Triglycerides (TG) at week 8
Time frame: 8 weeks
The level of Triglycerides (TG)
The level of Triglycerides (TG) at week 12
Time frame: 12 weeks
Proportion of patients' LDL-c below 70 mg/L
The proportion of patients in the two groups who achieved LDL-C levels below 70 mg/L at week 8
Time frame: 8 weeks
Proportion of patients' LDL-c below 70 mg/L
The proportion of patients in the two groups who achieved LDL-C levels below 70 mg/L at week 12
Time frame: 12 weeks