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
SunWay Biotech Co., LTD.
80 participants
Apr 1, 2023
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
Inclusion Criteria10
- 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.
- ≦BMI≦35.
- Blood routine examination (CBC; Complete blood count): the mean corpuscular volume MCV should not be less than 70 fL.
- Blood glucose level measurement meets any of the following conditions:
- (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.
- \. Those without other serious diseases (cancer, heart failure, myocardial infarction, liver cirrhosis, moderate to severe liver and kidney dysfunction, stroke, etc.).
- \. 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 If the condition changes and the use of hypoglycemic drugs is required, the trial must be withdrawn.
- \. During the test period, the daily routine and eating habits should be maintained without deliberately changing them.
Exclusion Criteria6
- 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.
- Those who take traditional Chinese medicine mainly red yeast rice.
- Have undergone surgery within one month.
Interventions
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
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05737342