Loading clinical trials...

COMPLETED

Red Yeast Rice for Primary Prevention of Hypercholesterolemia

Gut Microbiota and Bile Acids Mediate the Clinical Benefits of Red Yeast Rice for Primary Prevention of Hypercholesterolemia: A Pilot Observational Study

NCT06301906•Chang Gung Memorial Hospital

View on ClinicalTrials.gov

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.

Eligibility

Age

35 - 55 years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•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

Exclusion Criteria

•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);
•Use antibiotics, probiotics or weight-loss drugs for more than 3 consecutive days within 3 months before inclusion in the study;
•Drug abuse or poor compliance;
+1 more criteria

Locations (1)

Taoyuan branch of Chang Gung Memorial Hospital

Taoyuan District, Taiwan, Taiwan

Key Dates

Start Date

February 26, 2024

Primary Completion Date

December 31, 2025

Completion Date

December 31, 2025

Last Updated

March 20, 2026

Enrollment

ACTUAL participants

Conditions

Hypercholesterolemia

Interventions

LipoCol Forte Capsule 600mg twice a day

DRUG

A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)

NCT07058077

Heterozygous Familial Hypercholesterolemia (HeFH)

View study

RECRUITINGNA

Screening for Familial Hypercholesterolemia in Children

NCT06555120

Hypercholesterolemia, Familial

View study

RECRUITING

Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Inclisiran in Italy

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Red Yeast Rice for Primary Prevention of Hypercholesterolemia

Inclusion Criteria

Exclusion Criteria

A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)

Screening for Familial Hypercholesterolemia in Children

Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Inclisiran in Italy

Causes and Natural History of Dyslipidemias

Pharmacokinetics of Butyrate Tablet BKR-017

A Study to Evaluate the Efficacy and Safety of Fixed-Dose Combination of Pitavastatin/Ezetimib