Effect of ANKASCIN 568-P Products Regulating Blood Lipid

Study Overview
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Brief Summary
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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)

Detailed Description
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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.

Official Title
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Effect of ANKASCIN 568-P Products Regulating Blood Lipid- A Double-blind, Placebo-controlled Clinical Research

Conditions
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Hyperlipidemias

Intervention / Treatment
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* Dietary Supplement: ANKASCIN 568-P Red yeast rice capsules
* Dietary Supplement: Placebo Capsules


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ANKASCIN 568-P Red yeast rice capsules<br>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<br>* 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.<br>|
| Placebo Comparator: Placebo Capsules<br>Maltodextrin was used as a placebo. | Dietary Supplement: Placebo Capsules<br>* Maltodextrin was used as a placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improves total cholesterol (TC) | 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 |