Effect of ANKASCIN 568-P Products on Decreasing HbA1c and Regulating Blood Glucose
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
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
Treatments tested in this trial
- ANKASCIN 568-P Red yeast rice capsules
- Placebo Capsules
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov