Red Yeast Rice for Primary Prevention of Hypercholesterolemia

Recruiting

• Conditions: Hypercholesterolemia
• Interventions: Drug: LipoCol Forte Capsule 600mg bid

• Registration Number: NCT06301906
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-02
• Study Start: 2024-02-26
• Study First Submitted: 2024-02-29
• Study First Submitted QC: 2024-03-07
• Last Update Submitted: 2024-03-07
• Study First Posted: 2024-03-08
• Last Update Posted: 2024-03-08
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 50

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

1. Have received anti-hyperlipidemic drugs or red yeast rice treatment within the past month;
2. Female;
3. Have experienced rhabdomyolysis or abnormal liver function ALT >72 U/L due to taking red yeast rice;
4. Bleeding diseases, such as abnormal platelets, abnormal coagulation factors, or gastrointestinal tract infection within one month
5. Liver insufficiency ALT >72 U/L or renal insufficiency eGFR < 30 mL/min/1.73 m2;
6. Have ever had coronary heart disease, myocardial infarction or cerebrovascular disease;
7. Stressful situations, including hospitalization or surgery within the past or next month, and cancer still being treated;
8. Uncontrolled hypertension (blood pressure ≥160/100 mmHg);
9. Use antibiotics, probiotics or weight-loss drugs for more than 3 consecutive days within 3 months before inclusion in the study;
10. Drug abuse or poor compliance;
11. Use of traditional Chinese medicine in the past month

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	LipoCol Forte Capsule 600mg bid	-

Primary Outcome Measures

Name	Time	Method
Low Density Lipoprotein-Cholesterol (LDL-C)	before treatment, and 3, 6, 9, 12 months after treatments	This study will evaluate the efficacy and durability of LipoCol Forte capsules in the primary prevention of hypercholesterolemia.

Secondary Outcome Measures

Name	Time	Method
10-Year ASCVD Risk	before treatment, and 3, 6, 9, 12 months after treatments	use ASCVD risk estimator to calculate the 10-Year ASCVD Risk after LipoCol Forte capsules treatment

Trial Locations

Locations (1)

Taoyuan branch of Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan