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A 4-week Human Trial to Compare the Efficacy and Safety of Polycan, Polycalcium, placebo on Bone Metabolism

A 4 week randomized, double-blind human trial to compare the effects and safety of powder of Aureobasidium pullulans cultured solution, mixture of Aureobasidium pullulans cultured solution and calcium lactate gluconate with placebo on metabolism of bone/joint in subjects

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
CRIS
Registry ID
KCT0000205
Enrollment
90
Registered
2011-10-19
Start date
2010-12-01
Completion date
Unknown
Last updated
2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : The subjects have taken the test or placebo product once a day (2 pills per instance: 200mg per pill) 30 minutes after the breakfast with an appropriate amount of water (Total 400

Sponsors

Glucan
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
urinary DPY(Deoxypyridinoline)

Secondary

MeasureTime frame
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

Countries

Korea, Republic of

Contacts

Public ContactSoo-Jin Park

Daegu Haany University

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026