Evaluation of the Effectiveness and Safety of Zanthoxylum piperitum Leaf Extract against Mild Degenerative Osteoarthritis of Knee: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

J. Jeong, Soo-hwan Lee, Hong-ryoul Yoon, Soon-Joong Kim
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Abstract

Copyright © 2021 The Society of Korean Medicine Rehabilitation Objectives Degenerative osteoarthritis of knee is a disease with an increasing number of patients worldwide and its general treatments have some side effects. Methods 102 subjects were classified into test group 1, test group 2, and control group, and clinical trial products were taken for 12 weeks. The effectiveness was evaluated with changes in visual analogue scale, Korean-Western Ontario and McMaster Universities Osteoarthritis Index, inducible nitric oxide synthase, and cyclooxygenase-2. Results Both test group 1 and test group 2 were effective in reducing the pain of degenerative osteoarthritis of knee, and only test group 2 was effective in improving the ability to perform daily activities. No clinically significant changes were observed for any safety parameter. Conclusions In conclusion, the data of this study indicate that Zanthoxylum piperitum leaf extract has effectiveness and safety against mild degenerative osteoarthritis of knee. (J Korean Med Rehabil 2021;31(4):167-191)
花椒叶提取物治疗轻度退行性膝关节骨关节炎的有效性和安全性评价:一项随机、双盲、安慰剂对照的临床试验
版权所有©2021韩国医学康复目标学会膝关节退行性骨关节炎是一种世界范围内患者数量不断增加的疾病,其一般治疗有一些副作用。方法将102例受试者分为试验1组、试验2组和对照组,服用临床试验产品12周。通过视觉模拟评分、韩国-西部安大略和麦克马斯特大学骨关节炎指数、诱导型一氧化氮合酶和环氧化酶-2的变化来评估疗效。结果试验1组和试验2组均能有效减轻膝关节退行性骨关节炎的疼痛,仅试验2组能有效改善日常活动能力。没有观察到任何临床显著的安全参数变化。结论花椒叶提取物对轻度退行性膝关节骨性关节炎具有一定的疗效和安全性。[J] .韩国医学康复杂志,2021;31(4):167-191。
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