Effect of ANKASCIN 568-P Products Regulating Blood Lipid
Effect of ANKASCIN 568-P Products Regulating Blood Lipid- A Double-blind, Placebo-controlled Clinical Research
SunWay Biotech Co., LTD.
80 participants
Apr 1, 2023
INTERVENTIONAL
Conditions
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)
Eligibility
Inclusion Criteria7
- 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.
- ≦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 Criteria6
- 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.
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Interventions
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.
Maltodextrin was used as a placebo
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05737355