Actively Recruiting

Phase Not Applicable
Age: 20Years +
All Genders
ID05737355

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

Led by SunWay Biotech Co., LTD. · Updated on 2025-08-28

80

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to study the effects of long-term use of red yeast rice products on blood lipid levels, especially focusing on raising high-density lipoprotein cholesterol (HDL-C), while tracking the overall health of participants with hyperlipidemias. The trial is randomized, double-blind, and placebo-controlled, involving 80 subjects divided into two groups. It seeks to understand how these products influence cholesterol and lipid profiles over time. Participants will take either two red yeast rice capsules daily containing 440 mg of ANKASCIN 568-P or two placebo capsules containing maltodextrin for 24 weeks. The study has three periods: screening, treatment, and discontinuation follow-up. Blood samples and health measurements will be taken at the start, 4, 12, and 24 weeks to analyze biochemical markers, blood pressure, blood sugar, and organ functions. Throughout the study, participants will undergo general body measurements and monitoring of liver, kidney, and thyroid function. Researchers will collect blood samples for biochemical analysis at regular intervals. The primary outcome measured is the improvement in total cholesterol after 24 weeks. The study will also observe safety and overall health changes during and after the treatment period.

CONDITIONS

Brief Title

Effect of ANKASCIN 568-P Products Regulating Blood Lipid

Who Can Participate

Age: 20Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female aged 20 years or older (women of childbearing age must not be pregnant or breastfeeding during the study)
  • Mentally sound and able to communicate
  • Body mass index (BMI) between 18 and 35
  • Diagnosed with simple dyslipidemia and currently not taking cholesterol-lowering drugs or choosing not to take such drugs
  • Low-density lipoprotein cholesterol (LDL-C) between 130 and 190 mg/dL
  • High-density lipoprotein cholesterol (HDL-C) below 50 mg/dL
  • No serious diseases such as cancer, heart failure, diabetes, myocardial infarction, liver cirrhosis, moderate to severe liver or kidney dysfunction, or stroke
  • Will maintain usual daily routines and eating habits during the study without deliberate changes
Not Eligible

You will not qualify if you...

  • Triglyceride (TG) levels 500 mg/dL or higher
  • Blood pressure with systolic ≥ 200 mmHg or diastolic ≥ 140 mmHg
  • Moderate or severe liver or kidney dysfunction (e.g., liver enzymes more than 3 times normal limits, diagnosed liver cirrhosis, or eGFR ≤ 30 ml/min/1.73m²)
  • Pregnant or breastfeeding women
  • Use of traditional Chinese medicine mainly based on red yeast rice
  • Surgery within the past month
  • Serious diseases of heart, liver, kidney, or blood system; mental illness incompatible with study requirements
  • Inability to use the study product as required leading to incomplete data for safety or effectiveness assessment

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 24 weeks

Participants take either ANKASCIN 568-P red yeast rice capsules or placebo capsules daily to regulate blood lipid levels, while undergoing blood sample collection and health monitoring.

4 visits (in-person) at weeks 0, 4, 12, and 24 for blood sample collection and health assessments

Trial Site Locations

Total: 1 location

1

Tri-Service General Hospital, National Defense Medical Center, Taipei city,

Taipei, Taiwan, 114202

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Research Team

S

Sean Lin

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

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Monascin and ankaflavin act as novel hypolipidemic and high-density lipoprotein cholesterol-raising agents in red mold dioscorea.

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Chun-Lin Lee, Yu-Ping Hung, Ya-Wen Hsu...

https://pubmed.ncbi.nlm.nih.gov/23237237

The blood lipid regulation of Monascus-produced monascin and ankaflavin via the suppression of low-density lipoprotein cholesterol assembly and stimulation of apolipoprotein A1 expression in the liver.

Chun-Lin Lee, Ja-Yan Wen, Ya-Wen Hsu...

https://pubmed.ncbi.nlm.nih.gov/27422746