Effect of ANKASCIN 568-P Products Regulating Blood Lipid

ConditionHyperlipidemias

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age20+

SponsorSunWay Biotech Co., LTD.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

ANKASCIN 568-P Red yeast rice capsules
Dietary supplement
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.
Placebo Capsules
Dietary supplement
Maltodextrin was used as a placebo

Treatment groups

80 Participants

are divided into 2 treatment groups

Group A: ANKASCIN 568-P Red yeast rice capsulesExperimental treatment 1 intervention

Group B: Placebo CapsulesPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

24 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

SunWay Biotech Co., LTD.

Lead sponsor

Source ClinicalTrials.gov

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