Human study for investigating the effectiveness and safety of Cynanchum wilfordii on control of blood cholesterol
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0001733
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 84
1) Subject who voluntarily agrees to participate and sign in informed consent form
2) Adults (20 years = Age, both male and female)
3) 18 kg/m2 = BMI (Body Mass Index) = 30 kg/m2
4) Fasting blood LDL-cholesterol level = 130 mg/dL
5) Fasting blood triglyceride level< 300 mg/dL
1) Fasting blood LDL-cholesterol level = 190mg/dL
2) Subjects who had consistently consumed the drug related to lipid metabolism (ex. statin, diuretics, beta blocker.. etc.) or inflammation metabolism within 4 weeks before the first visit. The subject who have taken thiazide and beta blockers among the diuretics without change of dose during last one year and expected not to change the dosage during the study period.
3) Subjects who consumed the functional food or food related to lipid metabolism or inflammation within 4 weeks before the first visit (example: plantsterol, w-3 fatty acid, aloe, chitosan, onion extract. etc.)
4) Subjects who are controlling body weight or subjects who have changed of body weight more than 10% within 6 month before the first visit
5) Following diseases :
- myocardial infarction, stroke
- hypertension (Systolic Blood Pressure =140 mmHg OR Diastolic Blood Pressure =100 mmHg)
- Diabetes (fasting glucose level = 180 mg/dL)
- Liver dysfunction (AST, ALT = 2.5 X upper limit of normal range)
- Renal dysfunction (serum creatinine = 1.4 mg/dL)
- Chronic inflammatory bowel disease
- Autoimmune disease, hyperthyroidism, hypothyroidism or malignant tumor
6) Women receiving hormone therapy
7) Chronic smoker (= 20 cigarettes / day)
8) Subjects with alcoholism or subjects who consume of alcohol more than 140g per week (example: soju about 2.5 bottles/week OR 2.5 glasses/day)
9) Excessive exercise (= 10 hours / week)
10) Participation in other human study within 4 weeks before the first visit
11) Subjects who are sensitive to Cynanchum wilfordii
12) Pregnant or lactating women
13) Any condition that the principal investigator believes may put the subjects at undue risk
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Blood lipid profiles
- Secondary Outcome Measures
Name Time Method Markers of inflammation and blood circulation ;Vital sign, adverse events;Clinical pathology examination, electrocardiography