Efficacy and Safety of Porcine Placenta Hydrolysate on menopausal symptoms; A 12week, Multi-center, Randomized, Double-blind, Placebo-Controlled Clinical Trial
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0002021
- Lead Sponsor
- CellaMedic Korea
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
1) kupperman index = 30mm
2) Subject who agrees to participate in the study and signs the informed consent form
1) BMI(Body Mass Index) > 30Kg/m2
2) Hormone therapy within the past 3 months
3) Subject with uncontrolled hypertension (over 160/100mmHg, when measuring after 10 minutes steady)
4) Subject with uncontrolled diabetes mellitus (more than 180mg/dl of fasting glucose)
5) History of drug abuse, or alcoholism
6) Subject with AST(GOT) or ALT(GPT) or ?-GTP = 3 times the upper limit of normal
7) Subject with serum creatinine = 2 times the upper limit of normal
8) Subject who participated in any clinical trial within 1 month or plan to participate in the other clinical study
9) Inappropriate subject decided by the investigator
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Kupperman Index
- Secondary Outcome Measures
Name Time Method Markers of bone metabolism;Adverse Event