RCT for the Chinese Medicine in Treating Hypercholesterolemia

Efficacy and Safety of Dachaihu Decoction Combined Erzhiwan With Variation for the Treatment of Hypercholesterolemia: A Parallel, Randomized, Double-blinded, Placebo-controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypercholesterolemia
• Intervention / Treatment: Drug: Dachaihu Decoction combined Erzhiwan with variation; Other: Placebo granules

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 Type: Interventional
• Enrollment (Estimated): 70
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Cho Wing Lo; Phone Number: 35053476; Email: louislo@cuhk.edu.hk
• Study Contact Backup: Name: Zhixiu Lin, Prof; Phone Number: 39436347; Email: linzx@cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo granules	Other: Placebo granules; Placebo granules
Experimental: Dachaihu Decoction combined Erzhiwan with variation granules; Chinese medicine granules	Drug: Dachaihu Decoction combined Erzhiwan with variation; Chinese medicine granules; Other Names: Chinese medicine granules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percent change in Low-density lipoprotein-cholesterol (LDL-C) levels	Compare the percent change in LDL-C levels from baseline to week 8	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percent change in Low-density lipoprotein-cholesterol (LDL-C) levels	Compare the percent change in LDL-C levels from baseline to week 4	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	12 weeks
The level of Low-density lipoprotein-cholesterol (LDL-C)	The level of LDL-C at week 4	4 weeks
The level of Low-density lipoprotein-cholesterol (LDL-C)	The level of LDL-C at week 8	8 weeks
The level of Low-density lipoprotein-cholesterol (LDL-C)	The level of LDL-C at week 12	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	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	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	12 weeks
The level of High-density lipoprotein-cholesterol (HDL-C)	The level of HDL-C at week 4	4 weeks
The level of High-density lipoprotein-cholesterol (HDL-C)	The level of HDL-C at week 8	8 weeks
The level of High-density lipoprotein-cholesterol (HDL-C)	The level of HDL-C at week 12	12 weeks
The percent change in Total cholesterol (TC) level	Compare the percent change in TC levels from baseline to week 4	4 weeks
The percent change in Total cholesterol (TC) level	Compare the percent change in TC levels from baseline to week 8	8 weeks
The percent change in Total cholesterol (TC) level	Compare the percent change in TC levels from baseline to week 12	12 weeks
The level of Total cholesterol (TC)	The level of HDL-C at week 4	4 weeks
The level of Total cholesterol (TC)	The level of HDL-C at week 8	8 weeks
The level of Total cholesterol (TC)	The level of HDL-C at week 12	12 weeks
The percent change in Triglycerides (TG)	Compare the percent change in TC levels from baseline to week 4	4 weeks
The percent change in Triglycerides (TG)	Compare the percent change in TC levels from baseline to week 8	8 weeks
The percent change in Triglycerides (TG)	Compare the percent change in TC levels from baseline to week 12	12 weeks
The level of Triglycerides (TG)	The level of Triglycerides (TG) at week 4	4 weeks
The level of Triglycerides (TG)	The level of Triglycerides (TG) at week 8	8 weeks
The level of Triglycerides (TG)	The level of Triglycerides (TG) at week 12	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	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	12 weeks

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Zhixiu Lin, Prof, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: November 20, 2024
• First Submitted That Met QC Criteria: November 20, 2024
• First Posted (Estimated): November 22, 2024

Study Record Updates

• Last Update Posted (Estimated): November 22, 2024
• Last Update Submitted That Met QC Criteria: November 20, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Hypercholesterolemia
• Other Study ID Numbers: Hypercholesterolemia study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No