Clinical trial NCT06700408: RCT for the Chinese Medicine in Treating Hypercholesterolemia
Official title: Efficacy and Safety of Dachaihu Decoction Combined Erzhiwan With Variation for the Treatment of Hypercholesterolemia: A Parallel, Randomized, Double-blinded, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Hypercholesterolemia
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2024-11-22
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The percent change in Low-density lipoprotein-cholesterol (LDL-C) levels
timeFrame: 8 weeks
Secondary outcomes:
measure: The percent change in Low-density lipoprotein-cholesterol (LDL-C) levels
timeFrame: 4 weeks
measure: The percent change in Low-density lipoprotein-cholesterol (LDL-C) levels
timeFrame: 12 weeks
measure: The level of Low-density lipoprotein-cholesterol (LDL-C)
timeFrame: 4 weeks
measure: The level of Low-density lipoprotein-cholesterol (LDL-C)
timeFrame: 8 weeks
measure: The level of Low-density lipoprotein-cholesterol (LDL-C)
timeFrame: 12 weeks
measure: The percent change in High-density lipoprotein-cholesterol (HDL-C) level
timeFrame: 4 weeks
measure: The percent change in High-density lipoprotein-cholesterol (HDL-C) level
timeFrame: 8 weeks
measure: The percent change in High-density lipoprotein-cholesterol (HDL-C) level
timeFrame: 12 weeks
measure: The level of High-density lipoprotein-cholesterol (HDL-C)
timeFrame: 4 weeks
measure: The level of High-density lipoprotein-cholesterol (HDL-C)
timeFrame: 8 weeks
measure: The level of High-density lipoprotein-cholesterol (HDL-C)
timeFrame: 12 weeks
measure: The percent change in Total cholesterol (TC) level
timeFrame: 4 weeks
measure: The percent change in Total cholesterol (TC) level
timeFrame: 8 weeks
measure: The percent change in Total cholesterol (TC) level
timeFrame: 12 weeks
measure: The level of Total cholesterol (TC)
timeFrame: 4 weeks
measure: The level of Total cholesterol (TC)
timeFrame: 8 weeks
measure: The level of Total cholesterol (TC)
timeFrame: 12 weeks
measure: The percent change in Triglycerides (TG)
timeFrame: 4 weeks
measure: The percent change in Triglycerides (TG)
timeFrame: 8 weeks
measure: The percent change in Triglycerides (TG)
timeFrame: 12 weeks
measure: The level of Triglycerides (TG)
timeFrame: 4 weeks
measure: The level of Triglycerides (TG)
timeFrame: 8 weeks
measure: The level of Triglycerides (TG)
timeFrame: 12 weeks
measure: Proportion of patients' LDL-c below 70 mg/L
timeFrame: 8 weeks
measure: Proportion of patients' LDL-c below 70 mg/L
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Chinese University of Hong Kong
name: Zhixiu Lin, Prof
role: PRINCIPAL_INVESTIGATOR
References: