RecruitingNot ApplicableNCT05737342

Effect of ANKASCIN 568-P Products on Decreasing HbA1c and Regulating Blood Glucose

Effect of ANKASCIN 568-P Products on Decreasing HbA1c and Regulating Blood Glucose- A Double-blind, Placebo-controlled Clinical Research


Sponsor

SunWay Biotech Co., LTD.

Enrollment

80 participants

Start Date

Apr 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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)


Eligibility

Min Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a supplement called ANKASCIN 568-P (made from red yeast rice) can help lower blood sugar levels and HbA1c (a measure of average blood sugar over time) in adults with prediabetes or early diabetes who are not yet on medication. **You may be eligible if...** - You are 20 years old or older (not pregnant or breastfeeding) - Your BMI is between 18 and 35 - Your fasting blood sugar is between 100–125 mg/dL, OR your HbA1c is between 5.7–6.4%, OR you have diabetes but haven't taken blood sugar medication in the past month - You don't have serious illnesses like cancer, heart failure, stroke, or severe liver/kidney problems - You are willing to avoid blood sugar medications during the trial **You may NOT be eligible if...** - Your blood pressure is extremely high (systolic ≥200 or diastolic ≥140 mmHg) - You have moderate-to-severe liver or kidney problems - You are pregnant or breastfeeding - You are already taking diabetes medication or insulin - You regularly take traditional Chinese medicine containing red yeast rice - You had surgery in the past month Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTANKASCIN 568-P Red yeast rice 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.

DIETARY_SUPPLEMENTPlacebo Capsules

Maltodextrin was used as a placebo


Locations(1)

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

Taipei, Taiwan

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NCT05737342


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