RCT for the Chinese Medicine in Treating Hypercholesterolemia

NCT06700408 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: Hypercholesterolemia study
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (25)

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

  4 weeks

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

  12 weeks

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

  4 weeks

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

  8 weeks

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

  12 weeks

Study Arms (2)

Dachaihu Decoction combined Erzhiwan with variation granules

EXPERIMENTAL

Chinese medicine granules

Drug: Dachaihu Decoction combined Erzhiwan with variation

Placebo granules

PLACEBO COMPARATOR

Placebo granules

Other: Placebo granules

Interventions

Dachaihu Decoction combined Erzhiwan with variation DRUG

Chinese medicine granules

Also known as: Chinese medicine granules

Dachaihu Decoction combined Erzhiwan with variation granules

Placebo granules OTHER

Placebo granules

Placebo granules

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

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

Study Officials

• Zhixiu Lin, Prof

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhixiu Lin, Prof

CONTACT

39436347; linzx@cuhk.edu.hk

Cho Wing Lo

CONTACT

35053476; louislo@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: November 22, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share