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NCT Number: NCT06700408

RCT for the Chinese Medicine in Treating Hypercholesterolemia

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.

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dachaihu Decoction combined Erzhiwan with variation

Drug

Chinese medicine granules

Other names: Chinese medicine granules

Placebo granules

Other

Placebo granules

Primary outcomes

  1. The percent change in Low-density lipoprotein-cholesterol (LDL-C) levels

    Time frame: 8 weeks

    Compare the percent change in LDL-C levels from baseline to week 8

Secondary outcomes

  1. The percent change in Low-density lipoprotein-cholesterol (LDL-C) levels

    Time frame: 4 weeks

    Compare the percent change in LDL-C levels from baseline to week 4

  2. The percent change in Low-density lipoprotein-cholesterol (LDL-C) levels

    Time frame: 12 weeks

    Compare the percent change in LDL-C levels from baseline to week 12

  3. The level of Low-density lipoprotein-cholesterol (LDL-C)

    Time frame: 4 weeks

    The level of LDL-C at week 4

  4. The level of Low-density lipoprotein-cholesterol (LDL-C)

    Time frame: 8 weeks

    The level of LDL-C at week 8

  5. The level of Low-density lipoprotein-cholesterol (LDL-C)

    Time frame: 12 weeks

    The level of LDL-C at week 12

  6. The percent change in High-density lipoprotein-cholesterol (HDL-C) level

    Time frame: 4 weeks

    Compare the percent change in HDL-C levels from baseline to week 4

  7. The percent change in High-density lipoprotein-cholesterol (HDL-C) level

    Time frame: 8 weeks

    Compare the percent change in HDL-C levels from baseline to week 8

  8. The percent change in High-density lipoprotein-cholesterol (HDL-C) level

    Time frame: 12 weeks

    Compare the percent change in HDL-C levels from baseline to week 12

  9. The level of High-density lipoprotein-cholesterol (HDL-C)

    Time frame: 4 weeks

    The level of HDL-C at week 4

  10. The level of High-density lipoprotein-cholesterol (HDL-C)

    Time frame: 8 weeks

    The level of HDL-C at week 8

  11. The level of High-density lipoprotein-cholesterol (HDL-C)

    Time frame: 12 weeks

    The level of HDL-C at week 12

  12. The percent change in Total cholesterol (TC) level

    Time frame: 4 weeks

    Compare the percent change in TC levels from baseline to week 4

  13. The percent change in Total cholesterol (TC) level

    Time frame: 8 weeks

    Compare the percent change in TC levels from baseline to week 8

  14. The percent change in Total cholesterol (TC) level

    Time frame: 12 weeks

    Compare the percent change in TC levels from baseline to week 12

  15. The level of Total cholesterol (TC)

    Time frame: 4 weeks

    The level of HDL-C at week 4

  16. The level of Total cholesterol (TC)

    Time frame: 8 weeks

    The level of HDL-C at week 8

  17. The level of Total cholesterol (TC)

    Time frame: 12 weeks

    The level of HDL-C at week 12

  18. The percent change in Triglycerides (TG)

    Time frame: 4 weeks

    Compare the percent change in TC levels from baseline to week 4

  19. The percent change in Triglycerides (TG)

    Time frame: 8 weeks

    Compare the percent change in TC levels from baseline to week 8

  20. The percent change in Triglycerides (TG)

    Time frame: 12 weeks

    Compare the percent change in TC levels from baseline to week 12

  21. The level of Triglycerides (TG)

    Time frame: 4 weeks

    The level of Triglycerides (TG) at week 4

  22. The level of Triglycerides (TG)

    Time frame: 8 weeks

    The level of Triglycerides (TG) at week 8

  23. The level of Triglycerides (TG)

    Time frame: 12 weeks

    The level of Triglycerides (TG) at week 12

  24. Proportion of patients' LDL-c below 70 mg/L

    Time frame: 8 weeks

    The proportion of patients in the two groups who achieved LDL-C levels below 70 mg/L at week 8

  25. Proportion of patients' LDL-c below 70 mg/L

    Time frame: 12 weeks

    The proportion of patients in the two groups who achieved LDL-C levels below 70 mg/L at week 12

Study contacts

Contact information is provided by the study sponsor or research team.

Cho Wing Lo

CONTACT

[email protected]

35053476

Zhixiu Lin, Prof

CONTACT

[email protected]

39436347

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2027
Primary completion
2029
Study completion
2030
First posted
Nov 22, 2024
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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