NCT01402115|CompletedPhase 2/3ResultsDMC
A 12-week Human Trial to Compare the Efficacy and Safety of Polycan on Bone Metabolism
Efficacy and Safety Study of Polycan on Bone Metabolism
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Sponsor study identifier
interventional
60
1 country
1
Study Start
November 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2009
Actual (reported)Study Completion
May 2009
Actual (reported)Beta-glucans are polysaccharides consisting of glucose residue jointed by beta linkage. They are found at a high level in the cell wall of fungi, yeast, oat, barley, bacteria, as well as various mushroom. Studies have reported that extract of mushroom (Pleurotus eryngii) can prevent the bone loss caused by estrogen deficiency. Furthermore, polycan (a purified β-glucan from Aureobasidium pullulans) has been reported to exhibit osteoporosis preventing effects. However, no investigation has been conducted on the effect of polycan on bone health in perimenopausal women. Therefore, in this study, we investigated the effect of polycan on biochemical markers of bone metabolism in Korean perimenopausal women.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2009
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2008
Date type not reportedThis date has not been verified as actual or estimated.
February 2009
Actual (reported)May 2009
Actual (reported)July 21, 2011
Actual (reported)July 26, 2011
Actual (reported)October 5, 2012
Actual (reported)Changes in DPD(Deoxypyridinoline)
DPD(Deoxypyridinoline) was measured in study visit 1(0 week) and visit 3(12 week).
12weeks
Changes in OSC(Osteocalcin)
OSC(Osteocalcin) was measured in study visit 1(0 week) and visit 3(12 week).
12weeks
Changes in CTx(Collagen Type 1 Cross-linked C-telopeptide)
12weeks
Changes in bALP(Bone-specific Alkaline Phosphatase)
12weeks
Changes in PTH(Parathyroid Hormone)
12weeks
Polycan 150mg for 12 weeks
Placebo 15mg for 12 weeks
polycan 150 mg/d for 12 weeks
Placebo 150mg/d for 12 weeks
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Healthcare claims and management; Chonbuk National university
Jeonju, Jeollabuk-do, 560-822, South Korea
Dal-Sik Kim, MD
Chonbuk National University Hospital
60 participants (actual enrollment reported by the registry).
First Submitted
July 21, 2011
First Posted
July 26, 2011
Study Start
November 2008
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
February 2009
Actual (reported)Study Completion
May 2009
Actual (reported)Last Updated
October 12, 2012
Results First Posted
October 5, 2012
Record last verified: 2012-10
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Source: ClinicalTrials.gov.
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