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        Efficacy and Safety of a Flaxseed Hull Extract in the Symptomatic Management of Benign Prostatic Hyperplasia: A Parallel, Randomized, Double-Blind, Placebo-Controlled, Pilot Study

        Rudy Simons,Navneet Sonawane,Marian Verbruggen,Jayesh Chaudhary 한국식품영양과학회 2015 Journal of medicinal food Vol.18 No.2

        This exploratory study was designed to assess the effectiveness of a lignan-rich extract of flaxseed hulls (LinumLife EXTRA®) in alleviating symptoms in subjects with benign prostatic hyperplasia (BPH) compared with placebo. Two dosages of extract were compared against placebo in a double-blinded, randomized, parallel, multicenter study. Newly diagnosed cases of BPH in patients aged 45–75 years with an American Urological Association Symptom Index (AUASI) score of ≥ 13 were included. Study treatment consisted of 500 or 1000 mg of extract containing 100 mg (low-dose active [LDA] group, n = 26) or 200 mg (high-dose active [HDA] group, n = 26) of secoisolariciresinol diglucoside (SDG), respectively. The placebo (P) group (n = 28) received matching maltodextrin capsules. Sixty subjects (LDA [n = 19], HDA [n = 20], and P [n = 21]) completed the study as per the protocol requirements. Change in the AUASI score within a period of 8 weeks, from baseline to end of treatment, was assessed. Significant improvement of obstructive symptoms and management of irritable BPH symptoms was achieved in all groups after treatment. Due to a strong placebo effect, there was no statistical difference between the groups that were treated with flaxseed hull extract as compared with the placebo group. Treatment with flaxseed hull extract did not lead to adverse effects compared with placebo. Supplementation with flaxseed hull extract was found to be safe and well-tolerated and may have improved the quality of life of individuals with BPH. The significant placebo effect as well as the number of subjects per treatment group and the relative short duration of the study may explain the lack of statistical significance between groups.

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        Osteogenic Nanofibrous Coated Titanium Implant Results in Enhanced Osseointegration: In Vivo Preliminary Study in a Rabbit Model

        Siddhartha Das,Sandeep Gurav,Vivek Soni,Arvind Ingle,Bhabani S. Mohanty,Pradip Chaudhari,Kiran Bendale,Kanchan Dholam,Jayesh R. Bellare 한국조직공학과 재생의학회 2018 조직공학과 재생의학 Vol.15 No.2

        A titanium implant surface when coated with biodegradable, highly porous, osteogenic nanofibrous coating has shown enhanced intrinsic osteoinductive and osteoconductive properties. This coating mimics extracellular matrix resulting in differentiation of stem cells present in the peri-implant niche to osteoblast and hence results in enhanced osseointegration of the implant. The osteogenic nanofibrous coating (ONFC) consists of poly-caprolactone, gelatin, nano- sized hydroxyapatite, dexamethasone, ascorbic acid and beta-glycerophosphate. ONFC exhibits optimum mechanical properties to support mesenchymal stem cells and steer their osteogenic differentiation. ONFC was subjected to various characterization tests like scanning electron microscopy, Fourier-transform infrared spectroscopy, x-ray diffractometry, thermal degradation, biomineralization, mechanical properties, wettability and proliferation assay. In pre-clinical animal trials, the coated implant showed enhanced new bone formation when placed in the tibia of rabbit. This novel approach toward implant bone integration holds significant promise for its easy and economical coating thus marking the beginning of new era of electrospun osteogenic nanofibrous coated bone implants.

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