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

ConditionsHigh Blood Sugar Metabolic Syndrome

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age20+

SponsorSunWay Biotech Co., LTD.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Men or non-pregnant women over 20 years old (women of childbearing age are not allowed to become pregnant or breastfeed during the study) adults who are sane and able to communicate.

18≦BMI≦35.

Blood routine examination (CBC; Complete blood count): the mean corpuscular volume MCV should not be less than 70 fL.

Disqualifiers

Blood pressure: systolic blood pressure ≧ 200 mmHg or diastolic blood pressure ≧ 140 mmHg.

Moderate or severe liver and kidney dysfunction (generally refers to serum aminopyruvate converting enzyme (SGPT) and serum glutamate phenylacetate transaminase (SGOT) are more than 3 times higher than the upper limit of normal value or have been diagnosed Liver cirrhosis, or glomerular filtration rate eGFR≦30 ml/min/1.73m2).

Pregnant or lactating women.

Diabetic patients taking hypoglycemic drugs or insulin injections.

Trial design

Design model

Parallel

Treatments tested in this trial

ANKASCIN 568-P Red yeast rice capsules
Dietary supplement
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.
Placebo Capsules
Dietary supplement
Maltodextrin was used as a placebo

Treatment groups

80 Participants

are divided into 2 treatment groups

Group A: ANKASCIN 568-P Red yeast rice capsulesExperimental treatment 1 intervention

Group B: Placebo CapsulesPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

SunWay Biotech Co., LTD.

Lead sponsor

Source ClinicalTrials.gov

Apply now