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一项关于G-Rup®糖浆(姜提取物与蜂蜜的混合物)对症治疗膝骨关节炎安全性和有效性的随机、双盲、安慰剂对照I期临床研究。

A randomized, double-blind placebo-controlled phase I clinical study on safety and efficacy of the G-Rup® syrup (a mixture of ginger extract and honey) in symptomatic treatment of knee osteoarthritis.

作者信息

Afshar Fariba, Abdolahi Nafiseh, Amin Gholamreza, Esmaily Hadi, Ziayie Shadi, Azimi Saeed, Darvishi Behnam, Afshar Shima

机构信息

Department of internal medicine, Faculty of Medicine, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran.

Rheumatology Research Center, Golestan University of Medical Sciences, Gorgan, Iran.

出版信息

J Clin Pharm Ther. 2022 Dec;47(12):2295-2301. doi: 10.1111/jcpt.13812. Epub 2022 Nov 30.

Abstract

WHAT IS KNOWN AND OBJECTIVES

Present study evaluated the safety profile and efficacy of G-Rup® syrup (100 mg/ml ginger extract plus 150 mg/ml honey) in symptomatic treatment of knee osteoarthritis (OA).

METHODS

Patients diagnosed with knee OA were randomly assigned (1:1) to receive either of a 30 ml twice daily regimen of G-Rup® syrup or placebo over a 12-week period. Primary endpoints of the study comprised of an improvement in the joint's stiffness, physical functioning and pain score, assessed by WOMAC questionnaire and the visual analog scale (VAS). Secondary objectives comprised of safety and tolerability of the syrup by patients.

RESULTS AND DISCUSSION

The 30 ml twice-daily regimen of G-Rup® syrup was safe and well tolerated by patients. Moreover, in whole studied time points, treatment with G-Rup® syrup could significantly Power the VAS score (p < 0.001) whereas improving WOMAC total score (p < 0.001) and pain (p < 0.001), physical functioning (p < 0.001), and stiffness sub-scores (p = 0.006) compared to the placebo receiving group.

WHAT IS NEW AND CONCLUSION

Based on obtained results, the G-Rup® syrup, composed of a combination of honey and ginger, may be a proper supplementary choice, along with routine therapeutic regimens, for improvement of symptomatic treatment of OA.

摘要

已知信息与研究目的

本研究评估了G-Rup®糖浆(100毫克/毫升姜提取物加150毫克/毫升蜂蜜)对膝关节骨关节炎(OA)进行症状治疗时的安全性和疗效。

方法

被诊断为膝关节OA的患者被随机分配(1:1),在12周内每日两次接受30毫升G-Rup®糖浆或安慰剂治疗。研究的主要终点包括通过WOMAC问卷和视觉模拟量表(VAS)评估的关节僵硬、身体功能和疼痛评分的改善情况。次要目标包括患者对该糖浆的安全性和耐受性。

结果与讨论

G-Rup®糖浆每日两次30毫升的治疗方案对患者来说是安全且耐受性良好的。此外,在整个研究时间点,与接受安慰剂组相比,用G-Rup®糖浆治疗可显著降低VAS评分(p < 0.001),同时改善WOMAC总分(p < 0.001)以及疼痛(p < 0.001)、身体功能(p < 0.001)和僵硬子评分(p = 0.006)。

新发现与结论

基于所获结果,由蜂蜜和姜混合而成的G-Rup®糖浆,可能是一种合适的辅助选择,与常规治疗方案一起用于改善OA的症状治疗。

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