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NCT06301906

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
Chang Gung Memorial Hospital·ClinicalTrials.gov·drugRecruiting
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Study focus
Disease/Condition
Hypercholesterolemia
Drug/Device/Intervention
LipoCol Forte Capsule 600mg bid
Study type
Observational
Intervention type
drug
Sponsor & location
Primary sponsor
Chang Gung Memorial Hospital
Location
Taoyuan, Taiwan
Timeline & enrollment
Phase
N/A
Start date
Feb 26, 2024
End date
Dec 31, 2025
Enrollment
50 participants
Primary outcome

Low Density Lipoprotein-Cholesterol (LDL-C)

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.

ICD-10 classifications
Pure hypercholesterolaemiaLipoprotein deficiencyHyperglycaemia, unspecifiedDisorders of lipoprotein metabolism and other lipidaemiasOther disorders of lipoprotein metabolism
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06301906
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06301906 through Pure Global AI's free database. This phase not specified trial is sponsored by Chang Gung Memorial Hospital and is currently Recruiting. The study focuses on Hypercholesterolemia. Target enrollment is 50 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.