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

S&D0 个研究点目标入组 80 人开始时间: 待定最近更新: 2019年3月11日

适应症

试验速览

暂无简介。

•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.

•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.

发起方

S&D