Ku Yong Ho, Lee Hyun, Ryu Hwa Yeon, Park Hae-Jin, Shin Mi-Rae, Kang Jae Hui
Department of Acupuncture and Moxibustion Medicine, College of Korean Medicine, Daejeon University.
Department of Herbology.
Medicine (Baltimore). 2020 Feb;99(8):e18912. doi: 10.1097/MD.0000000000018912.
Knee osteoarthritis (KOA) is the most common form of degenerative arthritis. We used Phellinus linteus (PL), which has been well-known anti-inflammatory function. In this study, we will evaluate if PL extract improves symptoms with KOA.
This study will be an 8-week single-center randomized controlled double-blind clinical trial. Total of 24 subjects with KOA will be enrolled and they will be divided into 3 groups, PL 1,000 mg, PL 1,500 mg and placebo. Subjects will be followed up every 4 weeks with efficacy and safety at the 2nd and 3rd visits. All subjects should maintain a dosage schedule for this protocol. The primary outcome will be assessed with the Korean version of the Western Ontario and McMasters Universities. And the secondary outcomes will be measured using the visual analog scale, quality of life scale (EQ-5D-3L), ESR, C-reactive protein, and C-telopeptide of type-II collagen. Statistical analysis will be performed on the principle of full analysis set.
This study has inclusion and exclusion criteria and a well-controlled intervention. This clinical trial is the first step to assess the efficacy and safety of PL in patients with KOA. This study will make an important contribution to the literature and aid follow-up research into the use of PL in KOA.
膝骨关节炎（KOA）是最常见的退行性关节炎形式。我们使用了具有抗炎功能的桑黄（PL）。在本研究中，我们将评估PL提取物是否能改善KOA的症状。
本研究将是一项为期8周的单中心随机对照双盲临床试验。总共将招募24名KOA患者，并将他们分为3组，即1000毫克PL组、1500毫克PL组和安慰剂组。每4周对受试者进行随访，在第2次和第3次访视时评估疗效和安全性。所有受试者都应遵守本方案的给药计划。主要结局将采用韩国版的西安大略和麦克马斯特大学骨关节炎指数进行评估。次要结局将使用视觉模拟量表、生活质量量表（EQ-5D-3L）、红细胞沉降率、C反应蛋白和II型胶原C末端肽进行测量。将按照全分析集原则进行统计分析。
本研究有纳入和排除标准以及严格控制的干预措施。这项临床试验是评估PL对KOA患者疗效和安全性的第一步。本研究将为文献做出重要贡献，并有助于后续对PL在KOA中应用的研究。
