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Red Yeast Rice for Primary Prevention of Hypercholesterolemia - Trial NCT06301906

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.

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NCT06301906
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Trial Details
ClinicalTrials.gov โ€ข NCT06301906
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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

Study Focus

Hypercholesterolemia

LipoCol Forte Capsule 600mg bid

Observational

drug

Sponsor & Location

Chang Gung Memorial Hospital

Taoyuan, Taiwan

Timeline & Enrollment

N/A

Feb 26, 2024

Dec 31, 2025

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 hypercholesterolaemia
Lipoprotein deficiency
Hyperglycaemia, unspecified
Disorders of lipoprotein metabolism and other lipidaemias
Other disorders of lipoprotein metabolism

Data Source

ClinicalTrials.gov

NCT06301906

Non-Device Trial