NCT06700408

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	Dachaihu Decoction combined Erzhiwan with variation	Chinese medicine granules
OTHER	Placebo granules	Placebo granules

Timeline

• Start date: 2025-01-01
• Primary completion: 2026-12-01
• Completion: 2027-04-01
• First posted: 2024-11-22
• Last updated: 2024-11-22