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 Publisher Pubmed



Afshar F¹ ; Abdolahi N² ; Amin G³ ; Esmaily H⁴ ; Ziayie S⁴ ; Azimi S⁴ ; Darvishi B⁵ ; Afshar S⁴ Show Affiliations
Source: Journal of Clinical Pharmacy and Therapeutics Published:2022

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. © 2022 John Wiley & Sons Ltd.