Clinical trial for the evaluation of the efficacy and safety of the extracts of lotus leaf complex on blood lipid levels.
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0003136
- Lead Sponsor
- Korea Inspharm
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 68
A borderline dyslipidemia diagnosed with one of abnormalities of serum lipid level followed total cholesterol (200-239 mg/dl) or LDL-cholesterol (130-159 mg/dl) or triglyceride (150-199 mg/dl).
1) subjects who were pregnant and breastfeeding or participating in other clinical trials within 3 months,
2) subjects with secondary dyslipidemia due to hypothyroidism, nephritic syndrome or other diseases,
3) subjects with cardiovascular diseases (angina pectoris, myocardial infarction and coronary artery bypass graft),
4) subjects who had medical history of pancreatic diseases (e.g. pancreatitis or deficiency in pancreatic),
5) subjects whose AST/ALT level was more than 3 times higher than the upper limit of the normal,
6) subjects who were receiving hormone treatment,
7) subjects of uncontrolled high blood pressure (over 170/100mmHg, when screened),
8) subjects who had diabetes, which is hard to control blood glucose level,
9) subjects who had been addicted to drugs or alcohol before,
10) subjects who were illiteracy and
11) subjects who were considered as inappropriate.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method