12 weeks, randomized, double-blind, placebo-controlled clinical trial for the evaluation of the efficacy and safety of SD1001F on serum cholesterol.

Not Applicable

Recruiting

• Conditions: Endocrine, nutritional and metabolic disease

• Registration Number: KCT0000833
• Lead Sponsor: S&D

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1) Male and female subjects between 20-60years of age inclusive.
2) Serum total cholesterol 170-250mg/dl or LDL cholesterol 130-189mg/dl 3) Evidense of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial.

Exclusion Criteria

1) Subjects who taking anti-hypercholesterolemia within the 3 months prior to screening.
2) Subjects who taking a beta blocker or a hydragogue within the 3 months prior to screening.
3) Subjects who drinks alcohol 4 times per a week/ Subjects who get hospitalization, medications or rehabilitation treatments for cardiovascular disease, disorder of central nervous system
4) Serum creatinine = 2 times the upper limit of normal.
5) Serum AST/ALT = 3 times the upper limit of normal.
6) subject for uncontrolled hypertension, diabetes mellitus, thyroid disease (If that patient's clinical status is stable, they can participate in the clinical trial in the sight of investigator).
7) Subjects who complain gastrointestinal symptoms such as heartburn, dyspepsia
8) Subjects with Gallbladder disease or gastrointestinal disease, gout, porphyrias
9) Subjects with CNS disorder(depressive disorder, schizophrenia, alcoholism, drug addiction).
10) Subjects with malnutrition.
11) Woman who are pregnant or lactating or planning to pregnant
12) Subjects who have a plan to participate in other clinical trial
13) Participation in any clinical trial within the 3 months prior to screening.
14) Subjects which in the opinion investigator could affect preclude evauation of response.

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total cholesterol;LDL-cholesterol ;HDL-cholesterol

Secondary Outcome Measures

Name	Time	Method
Triglyceride;Apoprotein A1 ;Apoprotein B ;Lipoprotein A ;Atherogenic Index;Body Mass Index