Clinical trial NCT05737355: Effect of ANKASCIN 568-P Products Regulating Blood Lipid
Official title: Effect of ANKASCIN 568-P Products Regulating Blood Lipid- A Double-blind, Placebo-controlled Clinical Research
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hyperlipidemias
Lead sponsor: SunWay Biotech Co., LTD.
Sponsor class: INDUSTRY
First posted: 2023-02-21
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Improves total cholesterol (TC)
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Chief of Family medicine department
name: WEN-HUI FANG, Ph. D.
role: PRINCIPAL_INVESTIGATOR
References:
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