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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Taiwan
Tri-Service General Hospital, National Defense Medical Center, Taipei city,
RECRUITING
Taipei
Contact Information
Primary
Sean Lin
sean.lin@sunway.cc
02-27929568
Time Frame
Start Date: 2023-04-01
Estimated Completion Date: 2025-10-31
Participants
Target number of participants: 80
Treatments
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.
Placebo_comparator: Placebo Capsules
Maltodextrin was used as a placebo.
Related Therapeutic Areas
Sponsors
Leads: SunWay Biotech Co., LTD.

This content was sourced from clinicaltrials.gov