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

SunWay Biotech

Status: Not yet enrolling

Conditions: High Blood Sugar; Metabolic Syndrome

Treatments: Dietary Supplement: Placebo Capsules; Dietary Supplement: ANKASCIN 568-P Red yeast rice capsules

Study type: Interventional

Funder types: Industry

Identifiers

NCT05737342

22 ANKASCIN 568-P

Details and patient eligibility

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)

Full description

This trial is a randomized double-blind human trial, mainly to investigate the effect of long-term consumption of red yeast rice products on reducing glycated hemoglobin (HbA1c) and regulating blood sugar. It is expected to recruit 80 subjects for a period of 24 weeks. The test group takes 2 capsules of red yeast rice per day (Each capsule contains 440mg ANKASCIN 568-P), the control group took placebo capsules daily, blood samples were collected for biochemical analysis at 0, 4, 12, and 24 weeks, and the general body position measurement, blood pressure, Blood lipids, blood sugar and other related changes, and monitor liver, kidney, thyroid function.

Enrollment: 80 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.
2. 18≦BMI≦35.
3. Blood routine examination (CBC; Complete blood count): the mean corpuscular volume MCV should not be less than 70 fL.
4. 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.

5. Those without other serious diseases (cancer, heart failure, myocardial infarction, liver cirrhosis, moderate to severe liver and kidney dysfunction, stroke, etc.).

6. 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.

7. During the test period, the daily routine and eating habits should be maintained without deliberately changing them.

Exclusion criteria

1. Blood pressure: systolic blood pressure ≧ 200 mmHg or diastolic blood pressure ≧ 140 mmHg.
2. 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).
3. Pregnant or lactating women.
4. Diabetic patients taking hypoglycemic drugs or insulin injections.
5. Those who take traditional Chinese medicine mainly red yeast rice.
6. Have undergone surgery within one month.
7. Combined with serious diseases such as heart, liver, kidney and hematopoietic system, mentally ill patients who do not meet the inclusion criteria, who do not eat the test samples according to the regulations, so that the efficacy cannot be judged or the incomplete data affect the judgment of efficacy or safety.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

ANKASCIN 568-P Red yeast rice capsules

Experimental group

Description:

ANKASCIN 568-P is a fermented product from the red yeast rice fungus \<Monascus purpureus NTU 568\>. It does not contain Monacolin K, an ingredient that may harm the human body, and is rich in new active ingredients. Take 2 red yeast rice capsules (each containing 440mg ANKASCIN 568-P) every day, and the control group takes 2 placebo capsules (containing equal weight maltodextrin) every day, respectively, at the 0th, 4th , , 12, 24, Collect blood samples for biochemical analysis and record the general body position measurement, blood pressure, blood lipid, blood sugar and other related changes of the subjects, and monitor the liver, kidney, and thyroid functions.

Treatment:

Dietary Supplement: ANKASCIN 568-P Red yeast rice capsules

Placebo Capsules

Placebo Comparator group

Description:

Maltodextrin was used as a placebo.

Treatment:

Dietary Supplement: Placebo Capsules