A 4-week Human Trial to Compare the Efficacy and Safety of Polycan, Polycalcium, placebo on Bone Metabolism
- Conditions
- Not Applicable
- Registration Number
- KCT0000205
- Lead Sponsor
- Glucan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 90
1.healthy adult female of 40-70 years old with no specific diseases
2.The osteogenesis marker of Osteocalcin value is within normal range or osteoclasis marker of deoxypyridinoline value is within normal range
3.Those who heard and completely understood the detailed description of this clinical test, and wish to participate voluntarily, and made a written consent to abide by the rules
4.Those who can be monitored during the human application test period
1.Those who received hormone replacement therapy, calcitonin, or bisphosphonate treatment and such within 6 months of the screening test
2.Those who were taking beta-adrenaline acceptor suppressant within 2 months of the screening test
3.Those who are taking hyperlipidemia / endocrine disease treatments, hormone product, bean-containing health functional food, etc. within 2 months of the screening test
4.Those who are taking Vitamin D, K, and Ca supplement within 4 weeks of screening test
5.Those who are taking steroid-type drug or oriental medicine that may influence bone metabolism
6.Those who have had other clinical test medicine within 1 month
7.Cancer patients with breast cancer, ovary cancer, endometrium cancer, cervical cancer, bone cancer, etc.
8.Those with diseases influencing bone metabolism (liver, kidney diseases, blood diseases, etc.)
9.Those with important history or a current disease in terms of neurology/psychology
10.Expectant mother, lactating woman, fertile woman who do not agree to undertake an appropriate contraception method (hormone contraceptive: pills, intrauterine device: loop, block contraception: femidom, intravaginal spermicide), drug addicts
11.Others deemed inappropriate by the discretion of the researcher in charge or the test representative
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method urinary DPY(Deoxypyridinoline)
- Secondary Outcome Measures
Name Time Method blood OSC(osteocalcin);blood BALP(bone-specific alkaline phosphatase), ;blood CTX(C-telopeptide of type-I collagen);blood NTX(N-telopeptide of type-I collagen);blood Hyaluronic acid;urinary Ca;urinary P