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Not yet recruiting NCT06700408

RCT for the Chinese Medicine in Treating Hypercholesterolemia

Phase II Interventional Hypercholesterolemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dachaihu Decoction combined Erzhiwan with variation, Placebo granules.
Who it may be relevant to
Registry conditions: Hypercholesterolemia. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

  • Drug Dachaihu Decoction combined Erzhiwan with variation
    Chinese medicine granules
  • Other Placebo granules
    Placebo granules

Primary outcome measures

  • The percent change in Low-density lipoprotein-cholesterol (LDL-C) levels [Time frame: 8 weeks]
Secondary outcome measures (12)
  • The percent change in Low-density lipoprotein-cholesterol (LDL-C) levels [Time frame: 4 weeks]
  • The percent change in Low-density lipoprotein-cholesterol (LDL-C) levels [Time frame: 12 weeks]
  • The level of Low-density lipoprotein-cholesterol (LDL-C) [Time frame: 4 weeks]
  • The level of Low-density lipoprotein-cholesterol (LDL-C) [Time frame: 8 weeks]
  • The level of Low-density lipoprotein-cholesterol (LDL-C) [Time frame: 12 weeks]
  • The percent change in High-density lipoprotein-cholesterol (HDL-C) level [Time frame: 4 weeks]
  • The percent change in High-density lipoprotein-cholesterol (HDL-C) level [Time frame: 8 weeks]
  • The percent change in High-density lipoprotein-cholesterol (HDL-C) level [Time frame: 12 weeks]
  • The level of High-density lipoprotein-cholesterol (HDL-C) [Time frame: 4 weeks]
  • The level of High-density lipoprotein-cholesterol (HDL-C) [Time frame: 8 weeks]
  • The level of High-density lipoprotein-cholesterol (HDL-C) [Time frame: 12 weeks]
  • The percent change in Total cholesterol (TC) level [Time frame: 4 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06700408 · Hypercholesterolemia study

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗