CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 60 enrolled
Drug / intervention
Polycan +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01402115
NCT01402115Phase 3Completed
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Efficacy and Safety Study of Polycan on Bone Metabolism

Chonbuk National University Hospital·interventional·Posted Jul 26, 2011·Updated Oct 12, 2012

In Brief

A Phase 3 clinical trial evaluating Polycan and Placebo for Bone Health in Perimenopausal Women. Completed, enrolled 60 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBone Health in Perimenopausal Women
CountriesSouth Korea
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 26, 2011
Enrollment StartNov 1, 2008
Primary CompletionFeb 1, 2009
Study CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 14.9 years ago

Interventions

Polycandietary

polycan 150 mg/d for 12 weeks

Placebodietary

Placebo 150mg/d for 12 weeks