RCT for the Chinese Medicine in Treating Hypercholesterolemia

Phase 2

Not yet recruiting

• Conditions: Hypercholesterolemia
• Interventions: Drug: Dachaihu Decoction combined Erzhiwan with variation; Other: Placebo granules

• Registration Number: NCT06700408
• Lead Sponsor: Chinese University of Hong Kong

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.

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-20
• Study First Submitted QC: 2024-11-20
• Last Update Submitted: 2024-11-20
• Study First Posted: 2024-11-22
• Last Update Posted: 2024-11-22
• Study Start: 2025-01
• Primary Completion: 2026-12
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dachaihu Decoction combined Erzhiwan with variation granules	Dachaihu Decoction combined Erzhiwan with variation	Chinese medicine granules
Placebo granules	Placebo granules	Placebo granules

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
The percent change in Low-density lipoprotein-cholesterol (LDL-C) levels	12 weeks	Compare the percent change in LDL-C levels from baseline to week 12
The level of Low-density lipoprotein-cholesterol (LDL-C)	12 weeks	The level of LDL-C at week 12
The percent change in High-density lipoprotein-cholesterol (HDL-C) level	12 weeks	Compare the percent change in HDL-C levels from baseline to week 12
The level of High-density lipoprotein-cholesterol (HDL-C)	12 weeks	The level of HDL-C at week 12
The percent change in Total cholesterol (TC) level	12 weeks	Compare the percent change in TC levels from baseline to week 12
The level of Total cholesterol (TC)	12 weeks	The level of HDL-C at week 12
The percent change in Triglycerides (TG)	12 weeks	Compare the percent change in TC levels from baseline to week 12
The level of Triglycerides (TG)	12 weeks	The level of Triglycerides (TG) at week 12
Proportion of patients' LDL-c below 70 mg/L	12 weeks	The proportion of patients in the two groups who achieved LDL-C levels below 70 mg/L at week 12