Red yeast rice to help lower LDL and raise HDL cholesterol

Effect of ANKASCIN 568-P Products Regulating Blood Lipid- A Double-blind, Placebo-controlled Clinical Research

This trial will test whether taking ANKASCIN 568-P red yeast rice capsules daily for 24 weeks can lower LDL cholesterol and raise HDL cholesterol in adults with mild to moderate high cholesterol who are not on lipid‑lowering drugs.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 20 Years and up
• Sex: All
• Sponsor: SunWay Biotech Co., LTD. (Industry-sponsored)
• Locations: 1 site (Taipei)
• Trial ID: NCT05737355 on ClinicalTrials.gov

What this trial studies

This is a randomized, double‑blind, placebo‑controlled, parallel trial recruiting about 80 adults with LDL‑C 130–190 mg/dL and low HDL‑C, who will take either ANKASCIN 568‑P red yeast rice capsules or a matching placebo for 24 weeks. Participants will take two capsules daily (each capsule contains 440 mg ANKASCIN 568‑P) and undergo biochemical blood testing at baseline and at weeks 4, 12, and 24. The study will monitor blood lipids, blood glucose, blood pressure, body measurements, and liver, kidney, and thyroid function to track safety and overall health. There is a screening period before treatment and a discontinuation follow‑up after the 24‑week treatment period.

Who should consider this trial

Good fit: Adults aged 20 and older with BMI 18–35, LDL‑C 130–190 mg/dL and low HDL‑C who are not currently taking lipid‑lowering medications and have no major comorbidities are the intended participants.

Not a fit: People with very high triglycerides (TG ≥500 mg/dL), significant liver or kidney disease, recent cardiovascular events, those already on statins or other lipid‑lowering drugs, pregnant or breastfeeding women, or those with other serious illnesses are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, the product could lower LDL‑C and improve HDL‑C levels, which may reduce cardiovascular risk for participants.

How similar studies have performed: Prior clinical trials of red yeast rice formulations have shown LDL‑C lowering effects, though results vary by product composition and quality.

Eligibility criteria

Inclusion Criteria:

* Male or Female women over the age of 20 (women of childbearing age should not be pregnant or breastfeeding during the study period).
* A sane and communicative adult.
* 18≦BMI≦35.
* Sub-healthy people with simple dyslipidemia and those who have been judged by the doctor that they do not need to take hypolipidemic drugs for the time being, or those who insist on not taking drugs.
* Screening criteria Low-density lipoprotein cholesterol (LDL-C): 130\~190 mg/dL. screening criteria and high-density lipoprotein cholesterol (HLDL-C): below 50 mg/dL.
* Those without other serious diseases (cancer, heart failure, diabetes, myocardial infarction, liver cirrhosis, moderate to severe liver and kidney dysfunction, stroke, etc.).
* During the experiment, the daily routine and eating habits should be maintained and not changed deliberately.

Exclusion Criteria:

* Triglyceride TG≧500 mg/dL.
* Blood pressure value: systolic blood pressure ≧ 200 mmHg or diastolic blood pressure ≧ 140 mmHg.
* Patients with moderate or severe abnormal liver and kidney function (generally referring to serum aminopyruvate converting enzyme (SGPT), serum glutamate phenylacetate transaminase (SGOT) are more than 3 times the upper limit of normal or have been diagnosed Liver cirrhosis, or glomerular filtration rate eGFR≦30 ml/min/1.73m2).
* Pregnant or lactating women.
* Those who take traditional Chinese medicine mainly based on red yeast rice.
* Those who have undergone surgery within one month.
* Those who have serious diseases such as heart, liver, kidney, and hematopoietic system, mentally ill patients who do not meet the inclusion criteria, fail to use the test product according to the regulations so that the efficacy or safety cannot be judged due to incomplete data.

Where this trial is running

Taipei

• Tri-Service General Hospital, National Defense Medical Center, Taipei city, — Taipei, Taiwan (Recruiting)

Study contacts

• Principal investigator: WEN-HUI FANG, Ph. D. — Chief of Family medicine department
• Study coordinator: Sean Lin

Conditions Hyperlipidemias