An interventional study of ANKASCIN 568-P Red yeast rice capsules and Placebo Capsules in Hyperlipidemias, sponsored by SunWay Biotech Co., LTD.. Recruiting at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2025-08-28.
Sponsored by SunWay Biotech Co., LTD. · Not applicable, Interventional, and Treatment
This study is a randomized, double-blind, placebo-controlled, parallel-controlled trial (24 weeks in total), divided into three periods (screening, treatment, and discontinuation follow-up)
This study aims to investigate the effects of long-term consumption of red yeast rice products on blood lipid regulation and elevated high-density lipoprotein cholesterol (HDL-C), while also monitoring changes in the subjects' overall health. This randomized, double-blind, placebo-controlled trial aims to recruit 80 subjects, who will be randomly divided into two groups to receive either a red yeast rice product or a placebo for 24 weeks. The experimental group will take two red yeast rice capsules daily (each containing 440 mg of ANKASCIN 568-P), while the control group will take two similar-looking placebo capsules daily (containing an equal weight of maltodextrin). Blood samples will be collected and recorded for biochemical analysis at 0, 4, 12, and 24 weeks. General postural measurements will be taken, along with blood pressure, blood lipids, and blood glucose levels. Liver, kidney, and thyroid function will also be monitored.
821 studies on the registry are indexed under Hyperlipidemias; 105 are open to participants now.
This study's planned enrollment of 80 is close to the median of 87 across 691 interventional studies indexed under Hyperlipidemias.
Browse Hyperlipidemias studies →SunWay Biotech Co., LTD. is the lead sponsor of 7 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
ANKASCIN 568-P is a fermented product from the red yeast rice fungus \<Monascus purpureus NTU 568\>. It does not contain Monacolin K, an ingredient that may harm the human body, and is rich in new active ingredients. Take 2 red yeast rice capsules (each containing 440mg ANKASCIN 568-P) every day, and the control group takes 2 placebo capsules (containing equal weight maltodextrin) every day, respectively, at the 0th, 4th , , 12, 24, Collect blood samples for biochemical analysis and record the general body position measurement, blood pressure, blood lipid, blood sugar and other related changes of the subjects, and monitor the liver, kidney, and thyroid functions.
Dietary Supplement: ANKASCIN 568-P Red yeast rice capsules
Maltodextrin was used as a placebo.
Dietary Supplement: Placebo Capsules
Product ingredients: ANKASCIN 568-P red yeast rice product 440 mg,microcrystalline ,cellulose,Maltodextrin; capsule shell composition: HPMC (hydroxypropyl methylcellulose), purified water, titanium dioxide, gellan gum.
Maltodextrin was used as a placebo
Improves total cholesterol (TC)
Compare the improvement of total cholesterol (TC) between the test group and the placebo group after taking red yeast rice capsules or placebo capsules for 24 weeks. According to the results of Section 9. Statistical method, whether there is a statistical difference between the two groups.
Time frame: 24 weeks
Plan to share: No
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SunWay Biotech Co., LTD.