Clinical trial to assess efficacy and safety of Cynanchum wilfordii Radix extract in subjects with elavated cholesterol levels
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0003594
- Lead Sponsor
- TWOWINPHARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 120
1) Age between 20 and 65 years
2) Total Cholesterol level between 200 and 240 mg/dl
3) Provision of written informed consent
1) Taking any medication influencing lipid metabolism, such as statin, fibrate, beta-blocker or others, within the prior month and a long term ingestion of natural product-based health supplements
2) Have following diseases;
? Uncontrolled high blood pressure (>140/90 mmHg)
? Two and half fold higher than normal levels of alanine transaminase (ALT) and aspartate transaminase (AST)
? A higher value of creatinine than 1.4 mg/dl
? Either hypothryroisdim or hyperthyroidism
? A cancer
3) Had history of famillial hypercholesterolemia
4) Had a body mass index (BMI) with either less than 18 kg/m2 or higher than 30 kg/m2
5) Had participated in other clinical trials within 1 months
6) Reported high alcohol intake (>30 g/day, 120 g/week)
7) Other diseases that the researcher decides inappropriate to participate in the test
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total Cholesterol;Triglyceride;HDL-Cholesterol;LDL-Cholesterol
- Secondary Outcome Measures
Name Time Method Soluble vascular cell adhesion molecule (sVCAM-1);Intercellular Adhesion Molecule 1 (ICAM-1);Inflammation index (CRP, TNF-a)