Effect of ANKASCIN 568-P Products Regulating Blood Lipid

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Hyperlipidemias

In brief

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)

Key facts

Study ID

NCT05737355

Run by

SunWay Biotech Co., LTD.

People needed

80

Starts

2023-04-01

Expected to finish

2025-10-31

Last updated by the study team

2025-08-28

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Tri-Service General Hospital, National Defense Medical Center, Taipei city, — Taipei, Taiwan (enrolling)

Full record on ClinicalTrials.gov

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