Red Yeast Rice for Primary Prevention of Hypercholesterolemia

NCT06301906 | Completed

• 1 other identifier: 202301060A3
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

This two-year observational study will be conducted at the outpatient clinic of the Department of Traditional Chinese Medicine of Taoyuan Chang Gung Hospital from February 26, 2024 to December 31, 2025. This study will enroll 35\~55 year-old male patients who are expected to take LipoCol Forte Capsules for primary prevention of hypercholesterolemia. The investigators will collect the TCM constitution questionnaires from patients before taking LipoCol Forte Capsules and every three months after taking the medicine. At the same time, blood will be drawn to detect glycated hemoglobin, fasting blood sugar, insulin, lipids profile, liver and kidney function, creatine kinase, predictive parameters of atherosclerotic cardiovascular disease, and plasma bile acids, etc. Fecal samples will also be collected to analyze the intestinal microbiota and fecal bile acid composition. This study will evaluate the efficacy, durability and safety of LipoCol Forte capsules in the primary prevention of hypercholesterolemia in patients with different constitutions, as well as whether it can reduce the risk of cardiovascular disease, and its influence on bile acid metabolism and intestinal microbiota.

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• Low Density Lipoprotein-Cholesterol (LDL-C)

  This study will evaluate the efficacy and durability of LipoCol Forte capsules in the primary prevention of hypercholesterolemia.

  before treatment, and 3, 6, 9, 12 months after treatments

Secondary Outcomes (1)

• 10-Year Atherosclerotic Cardiovascular Disease (ASCVD) Risk

  before treatment, and 3, 6, 9, 12 months after treatments

Study Arms (1)

Group 1

Drug: LipoCol Forte Capsule 600mg twice a day

Interventions

LipoCol Forte Capsule 600mg twice a day DRUG

LipoCol Forte Capsule 600mg twice a day for 12 months

Group 1

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The investigators will collect the TCM constitution questionnaires from patients before taking LipoCol Forte Capsules and every three months after taking the medicine. At the same time, blood will be drawn to detect glycated hemoglobin, fasting blood sugar, insulin, lipids profile, liver and kidney function, creatine kinase, predictive parameters of atherosclerotic cardiovascular disease, and plasma bile acids, etc. Fecal samples will also be collected to analyze the intestinal microbiota and fecal bile acid composition.

You may qualify if:

• Aged 35\~55 years old
• LDL-C≥130mg/dl or patients with diabetes or chronic kidney disease with LDL-C ≥ 100mg/dl
• expected to receive LipoCol Forte Capsule 600mg bid

You may not qualify if:

• Have received anti-hyperlipidemic drugs or red yeast rice treatment within the past month;
• Female;
• Have experienced rhabdomyolysis or abnormal liver function ALT \>72 U/L due to taking red yeast rice;
• Bleeding diseases, such as abnormal platelets, abnormal coagulation factors, or gastrointestinal tract infection within one month
• Liver insufficiency ALT \>72 U/L or renal insufficiency eGFR \< 30 mL/min/1.73 m2;
• Have ever had coronary heart disease, myocardial infarction or cerebrovascular disease;
• Stressful situations, including hospitalization or surgery within the past or next month, and cancer still being treated;
• Uncontrolled hypertension (blood pressure ≥160/100 mmHg);
• Drug abuse or poor compliance;
• Use of traditional Chinese medicine in the past month

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Taoyuan branch of Chang Gung Memorial Hospital

Taoyuan District, Taiwan, 333, Taiwan

Location

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 8, 2024
• Study Start: February 26, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 20, 2026

Record last verified: 2024-02

Locations

TW (1)