Effect of ANKASCIN 568-P Products Regulating Blood Lipid

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

Effect of ANKASCIN 568-P Products Regulating Blood Lipid- 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 experiment hopes to understand the effect of long-term consumption of red yeast rice products on blood lipid regulation and high-density lipoprotein cholesterol (HDL-C) elevation and to monitor the changes in the subjects' overall health status. This case is a randomized, double-blind, placebo-controlled trial. It is expected to recruit 80 subjects and randomly assign them to 2 groups to take red yeast rice products or a placebo for 24 weeks. The test group takes one red yeast rice capsule (containing 220 mg ANKASCIN 568-P), the control group took a placebo capsule of similar appearance (containing an equal weight of maltodextrin) every day, and blood samples were collected at 0, 4, and 12, 24, weeks for biochemical analysis and recorded. Subjects' general body position measurement, blood pressure, blood lipids, blood sugar and other related changes, and monitoring of liver, kidney, and 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:

  • Male or Female women over the age of 20 (women of childbearing age should not be pregnant or breastfeeding during the study period).
  • A sane and communicative adult.
  • 18≦BMI≦35.
  • Sub-healthy people with simple dyslipidemia and those who have been judged by the doctor that they do not need to take hypolipidemic drugs for the time being, or those who insist on not taking drugs.
  • Screening criteria Low-density lipoprotein cholesterol (LDL-C): 130~190 mg/dL. screening criteria and high-density lipoprotein cholesterol (HLDL-C): below 50 mg/dL.
  • Those without other serious diseases (cancer, heart failure, diabetes, myocardial infarction, liver cirrhosis, moderate to severe liver and kidney dysfunction, stroke, etc.).
  • During the experiment, the daily routine and eating habits should be maintained and not changed deliberately.

Exclusion Criteria:

  • Triglyceride TG≧500 mg/dL.
  • Blood pressure value: systolic blood pressure ≧ 200 mmHg or diastolic blood pressure ≧ 140 mmHg.
  • Patients with moderate or severe abnormal liver and kidney function (generally referring to serum aminopyruvate converting enzyme (SGPT), serum glutamate phenylacetate transaminase (SGOT) are more than 3 times the upper limit of normal or have been diagnosed Liver cirrhosis, or glomerular filtration rate eGFR≦30 ml/min/1.73m2).
  • Pregnant or lactating women.
  • Those who take traditional Chinese medicine mainly based on red yeast rice.
  • Those who have undergone surgery within one month.
  • Those who have serious diseases such as heart, liver, kidney, and hematopoietic system, mentally ill patients who do not meet the inclusion criteria, fail to use the test product according to the regulations so that the efficacy or safety cannot be judged due to incomplete data.

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
Improves total cholesterol (TC)
Time Frame: 24 weeks
Compare the improvement of total cholesterol (TC) between the test group and the placebo group after taking red yeast rice capsules or placebo capsules for 24 weeks. According to the results of Section 9. Statistical method, whether there is a statistical difference between the two groups.
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

  • 23 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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