An interventional study of ANKASCIN 568-P Red yeast rice capsules and Placebo Capsules in High Blood Sugar and Metabolic Syndrome, 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 trial is a randomized double-blind human trial, mainly to investigate the effect of long-term consumption of red yeast rice products on reducing glycated hemoglobin (HbA1c) and regulating blood sugar. It is expected to recruit 80 subjects for a period of 24 weeks. The test group takes 2 capsules of red yeast rice per day (Each capsule contains 440mg ANKASCIN 568-P), the control group took placebo capsules daily, blood samples were collected for biochemical analysis at 0, 4, 12, and 24 weeks, and the general body position measurement, blood pressure, Blood lipids, blood sugar and other related changes, and monitor liver, kidney, thyroid function.
699 studies on the registry are indexed under Hyperglycemia; 105 are open to participants now.
This study's planned enrollment of 80 is above the median of 46 across 521 interventional studies indexed under Hyperglycemia.
Browse Hyperglycemia studies →SunWay Biotech Co., LTD. is the lead sponsor of 7 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
(1) The fasting blood sugar is between 100∼125 mg/dL, and the doctor judges that there is no need to use hypoglycemic drugs for the time being.
(2) Or the glycosylated hemoglobin is between 5.7∼6.4%, and the doctor judges that the use of hypoglycemic drugs is not needed for the time being.
(3) Diabetic patients who have no willingness to take medicine and have not taken hypoglycemic drugs in the past month.
5. Those without other serious diseases (cancer, heart failure, myocardial infarction, liver cirrhosis, moderate to severe liver and kidney dysfunction, stroke, etc.).
6. Hypoglycemic drugs are not allowed to be used during the trial. If the condition changes and the use of hypoglycemic drugs is required, the trial must be withdrawn.
7. During the test period, the daily routine and eating habits should be maintained without deliberately changing them.
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
Improve glycated hemoglobin (HbA1c) value
After 24 weeks of taking red yeast rice capsules or placebo gel, whether there is a statistical difference between the test group and the placebo group in terms of improving the HbA1c value of glycosylated hemoglobin.
Time frame: 24 weeks
Plan to share: No
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SunWay Biotech Co., LTD.