FLAVOCOXID: A MEDICAL FOOD THERAPY FOR OSTEOARTHRITIS

FLAVOCOXID：骨关节炎的医疗食品疗法

• 批准号: 7603212
• 负责人: SARAH LUISE MORGAN
• 金额: $ 3.74万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-01 至 2008-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7603212
• 关键词: Acacia catechu; Adult; Adverse effects; Alternative Therapies; Anxiety; Arachidonate 5-Lipoxygenase; Arachidonic Acids; Arthralgia; Blood; Botanicals; Chronic Disease; Collection; Computer Retrieval of Information on Scientific Projects Database; Daily; Degenerative polyarthritis; Disease; Elderly; Funding; Grant; Hand; Hemorrhage; Hip region structure; Inflammatory; Injury; Institution; Joints; Knee; Measures; Mental Depression; Non-Steroidal Anti-Inflammatory Agents; Ontario; Pain; Participant; Patient Monitoring; Physicians; Placebos; Plants; Purpose; Quality of life; Randomized; Rate; Research; Research Personnel; Resources; Safety; Scutellaria baicalensis; Source; Swelling; Symptoms; Testing; Time; Tissues; United States National Institutes of Health; Venous Thrombosis; Vertebral column; Visit; Walking; Week; articular cartilage; cyclooxygenase 1; foot; gastrointestinal; indexing; medical food; nephrotoxicity; novel

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. OA is a leading chronic disease in older adults and is characterized by degeneration of articular cartilage of the joints in hands, spine, knees, and hips. In joints, tissue injury and pain are caused by the conversion of arachidonic acid to such inflammatory compounds as cyclooxygenases-1 and -2 (COX-1 and -2) and 5-lipoxygenase (5-LO). Conventional NSAIDs inhibit COX-1 and -2, but have little or no effect on 5-LO. NSAIDs provide relief from the pain of OA; however, NSAIDS are also associated with significant side effects, including gastrointestinal bleeding, venous thrombosis, and nephrotoxicity. Novel alternative therapies with increased safety and efficacy with fewer or no side effects are desirable; plant-derived substances might be useful alternatives to NSAIDs. Flavocoxid, a botanical extract derived from two plants, Scutellaria baicalensis and Acacia catechu, has been shown to inhibit COX-1 and -2 as well as 5-LO. The purpose of this study is to evaluate the safety and efficacy of flavocoxid in relieving the symptoms of knee OA in adults. This study will last 12 weeks. Participants will be randomly assigned to one of two groups. Group 1 participants will receive daily flavocoxid; Group 2 participants will receive placebo. There will be 5 study visits: study entry and Weeks 2, 4, 8, and 12. Joint pain, tenderness, and swelling will be assessed at each study visit. A 30-foot timed walking test will also be performed at all visits. A physical exam and blood collection will occur at study entry and Week 12. Other study assessments will include safety monitoring, patient/physician global disease ratings, quality of life measures, depression and anxiety ratings, and measures of efficacy as determined by the Western Ontario and McMaster (WOMAC) OA index.

该子项目是利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 OA是老年人的主要慢性疾病，其特征在于手、脊柱、膝和髋关节的关节软骨退化。在关节中，组织损伤和疼痛是由花生四烯酸转化为诸如环氧合酶-1和-2（考克斯-1和-2）和5-脂氧合酶（5-LO）的炎性化合物引起的。常规NSAID抑制考克斯-1和-2，但对5-LO几乎没有影响。NSAID可缓解OA疼痛;然而，NSAID也与显著的副作用相关，包括胃肠道出血、静脉血栓形成和肾毒性。新的替代疗法，增加安全性和有效性，较少或没有副作用是可取的;植物源性物质可能是有用的替代非甾体抗炎药。Flavocoxid是一种来自两种植物黄芩和儿茶的植物提取物，已显示出抑制考克斯-1和-2以及5-LO。本研究的目的是评价黄酮环氧化酶在缓解成人膝关节OA症状方面的安全性和有效性。 本研究将持续12周。参与者将被随机分配到两组之一。第1组受试者将接受每日flavocoxid;第2组受试者将接受安慰剂。将进行5次研究访视：研究入组和第2、4、8和12周。将在每次研究访视时评估关节疼痛、压痛和肿胀。还将在所有访视时进行30英尺定时步行试验。将在入组研究和第12周时进行体格检查和采血。其他研究评估将包括安全性监测、患者/医生总体疾病评级、生活质量测量、抑郁和焦虑评级以及由西安大略和麦克马斯特（WOMAC）OA指数确定的疗效测量。