Actively Recruiting

Phase Not Applicable
Age: 20Years +
All Genders
NCT05737342

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

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

80

Participants Needed

1

Research Sites

134 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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)

CONDITIONS

Official Title

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

Who Can Participate

Age: 20Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Men or non-pregnant women over 20 years old who are mentally capable of communication
  • Body mass index (BMI) between 18 and 35
  • Mean corpuscular volume (MCV) in blood routine examination not less than 70 fL
  • Blood sugar meeting any of these: fasting blood sugar between 100 and 125 mg/dL without need for hypoglycemic drugs, or glycated hemoglobin between 5.7% and 6.4% without need for hypoglycemic drugs, or diabetic patients not taking hypoglycemic drugs in the past month and unwilling to take medicine
  • No serious diseases such as cancer, heart failure, myocardial infarction, liver cirrhosis, moderate to severe liver or kidney dysfunction, or stroke
  • No use of hypoglycemic drugs during the trial; withdrawal required if hypoglycemic drugs become necessary
  • Maintains regular daily routine and eating habits without deliberate changes during the trial
Not Eligible

You will not qualify if you...

  • Systolic blood pressure equal to or above 200 mmHg or diastolic blood pressure equal to or above 140 mmHg
  • Moderate or severe liver and kidney dysfunction, including elevated liver enzymes more than three times the normal limit or diagnosed liver cirrhosis, or low glomerular filtration rate (eGFR 30 ml/min/1.73m2 or less)
  • Pregnant or lactating women
  • Diabetic patients currently taking hypoglycemic drugs or insulin injections
  • Use of traditional Chinese medicine mainly containing red yeast rice
  • Surgery within the past month
  • Serious diseases affecting heart, liver, kidney, or blood system, mentally ill patients not meeting inclusion criteria, or inability to follow test requirements resulting in incomplete or unreliable data

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

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

Taipei, Taiwan, 114202

Actively Recruiting

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Research Team

S

Sean Lin

CONTACT

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