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蒸姜提取物治疗轻度骨关节炎的有效性和安全性:一项随机、双盲、安慰剂对照临床试验。

Effectiveness and safety of steamed ginger extract on mild osteoarthritis: a randomized, double-blind, placebo-controlled clinical trial.

机构信息

Department of Food Science & Nutrition, Woosuk University, Wanju 55338, Republic of Korea.

Healthcare Claims & Management Inc., Jeonju 54858, Republic of Korea.

出版信息

Food Funct. 2024 Sep 16;15(18):9512-9523. doi: 10.1039/d4fo01640h.

Abstract

The purpose of this study was to evaluate the efficacy and safety of steamed ginger extract (GGE03) in subjects with mild knee osteoarthritis (OA). In total, 100 subjects were randomly assigned (1 : 1) to the GGE03 (0.48 g day as GGE03) or placebo (0 g day as GGE03) group and administered 1.6 g of the product for 12 weeks. Biomarkers were measured before and after intervention. At the efficacy endpoint, pain visual analog scale (VAS) Korean-Western Ontario and McMaster University Osteoarthritis Index (K-WOMAC; total scores, sub-scores) and patient global assessment (PGA) were found to be decreased in a statistically significantly manner in the GGE03 group compared to the placebo group. No significant changes were observed in any safety endpoint. These results suggest that GGE03 intake is useful as a functional food because it has beneficial effects in terms of improving joint pain as well as managing or preventing knee OA without side effects.

摘要

本研究旨在评估蒸姜提取物(GGE03)在轻中度膝骨关节炎(OA)患者中的疗效和安全性。共 100 名受试者被随机分配(1:1)至 GGE03(0.48 g 日作为 GGE03)或安慰剂(0 g 日作为 GGE03)组,并接受 1.6 g 产品治疗 12 周。干预前后测量了生物标志物。在疗效终点时,与安慰剂组相比,GGE03 组的疼痛视觉模拟量表(VAS)韩国-安大略西部大学和麦克马斯特大学骨关节炎指数(K-WOMAC;总分、子评分)和患者整体评估(PGA)均显著降低。在任何安全性终点均未观察到显著变化。这些结果表明,GGE03 的摄入可用作功能性食品,因为它具有改善关节疼痛以及管理或预防膝 OA 的有益作用,且无副作用。

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