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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0000833

Enrollment

Registered

2013-08-28

Start date

2013-04-01

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : Subjetsl take orally self-administer SD1001F 1000mg or Placebo bid, 2Tab per day for 12weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Total cholesterol;LDL-cholesterol ;HDL-cholesterol	—

Secondary

Measure	Time frame
Triglyceride;Apoprotein A1 ;Apoprotein B ;Lipoprotein A ;Atherogenic Index;Body Mass Index	—

Countries

Korea, Republic of

Contacts

Public ContactIN SUN JEONG

Inje University Seoul Paik Hospital

Outcome results