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

March 2, 2023 updated by: SunWay Biotech Co., LTD.

Effect of ANKASCIN 568-P Products on Decreasing HbA1c and Regulating Blood Glucose- A Double-blind, Placebo-controlled Clinical Research

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)

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ANKASCIN 568-P Red yeast rice capsules
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.
Dietary supplement: ANKASCIN 568-P Red yeast rice capsules
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 Comparator: Placebo Capsules
Maltodextrin was used as a placebo.
Dietary supplement: Placebo Capsules
Maltodextrin was used as a placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improve glycated hemoglobin (HbA1c) value
Time Frame: 24 weeks
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.
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SunWay Biotech Co., LTD.

Investigators

  • Principal Investigator: WEN-HUI FANG, Ph. D., Chief of Family medicine department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2023

Primary Completion (Anticipated)

March 31, 2025

Study Completion (Anticipated)

May 31, 2025

Study Registration Dates

First Submitted

February 10, 2023

First Submitted That Met QC Criteria

February 10, 2023

First Posted (Actual)

February 21, 2023

Study Record Updates

Last Update Posted (Estimate)

March 6, 2023

Last Update Submitted That Met QC Criteria

March 2, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22 ANKASCIN 568-P

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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