Hypercholesterolemia
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGDachaihu Decoction combined Erzhiwan with variation
Chinese medicine granules
OTHERPlacebo granules
Placebo granules
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The percent change in Low-density lipoprotein-cholesterol (LDL-C) levels | 8 weeks | Compare the percent change in LDL-C levels from baseline to week 8 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The percent change in Low-density lipoprotein-cholesterol (LDL-C) levels | 4 weeks | Compare the percent change in LDL-C levels from baseline to week 4 |
| The level of Low-density lipoprotein-cholesterol (LDL-C) | 4 weeks | The level of LDL-C at week 4 |
| The percent change in High-density lipoprotein-cholesterol (HDL-C) level | 4 weeks | Compare the percent change in HDL-C levels from baseline to week 4 |
| The level of High-density lipoprotein-cholesterol (HDL-C) | 4 weeks | The level of HDL-C at week 4 |
| The percent change in Total cholesterol (TC) level | 4 weeks | Compare the percent change in TC levels from baseline to week 4 |
| The level of Total cholesterol (TC) | 4 weeks | The level of HDL-C at week 4 |
| The percent change in Triglycerides (TG) | 4 weeks | Compare the percent change in TC levels from baseline to week 4 |
| The level of Triglycerides (TG) | 4 weeks | The level of Triglycerides (TG) at week 4 |
| Proportion of patients' LDL-c below 70 mg/L | 8 weeks | The proportion of patients in the two groups who achieved LDL-C levels below 70 mg/L at week 8 |
Contacts
CONTACTZhixiu Lin, Prof
CONTACTCho Wing Lo
PRINCIPAL_INVESTIGATORZhixiu Lin, Prof
Chinese University of Hong Kong
Outcome results
None listed