Leads Clinical Research & Bio Services Pvt. Ltd., Bangalore, India.
R&D Centre, Akay Natural Ingredients Pvt. Ltd., Cochin, India.
Phytother Res. 2021 Mar;35(3):1443-1455. doi: 10.1002/ptr.6907. Epub 2020 Nov 18.
A 6-week, randomized, open-label, active-controlled clinical trial was conducted to evaluate the influence of a low-dose curcumagalactomannosides (CGM) (400 mg once daily) in OA subjects. The treatment was compared with a standard combination of 500 mg glucosamine hydrochloride (GLN) and 415 mg chondroitin sulphate (CHN), supplied as a single oral dose twice a day. Out of 84 subjects randomized, 72 subjects who have completed the study were evaluated for the safety and efficacy of the treatments at baseline and subsequent visits (day 28 and 42), by measuring walking performance, VAS, KPS, and WOMAC scores. CGM exhibited 47.02, 21.43, and 206% improvement in VAS, KPS, and walking performance, respectively, compared to the baseline. Similarly, there was 31.17, 32.93, 36.44, and 35% improvement in the pain, stiffness, physical function, and total WOMAC scores. CGM also caused a substantial reduction in the serum inflammatory marker levels. The results indicate that a short-term supplementation of a low dosage CGM exerted superior beneficial effects than a high-dosage CHN-GLN combination in alleviating the pain and symptoms of OA subjects. Further clinical trials of extended duration in a larger population is required to substantiate the efficacy of CGM in the long-term management of OA.
一项为期 6 周、随机、开放标签、阳性药物对照的临床试验，旨在评估低剂量姜黄素半乳甘露寡糖（CGM）（400mg 每日一次）对 OA 患者的影响。该治疗与每日两次口服 500mg 盐酸氨基葡萄糖（GLN）和 415mg 硫酸软骨素（CHN）的标准组合进行比较。84 名随机患者中，72 名完成研究的患者在基线和随后的访视（第 28 天和第 42 天）时，通过测量步行表现、VAS、KPS 和 WOMAC 评分，评估治疗的安全性和疗效。与基线相比，CGM 在 VAS、KPS 和步行表现方面分别改善了 47.02%、21.43%和 206%。同样，疼痛、僵硬、身体功能和 WOMAC 总分的评分分别改善了 31.17%、32.93%、36.44%和 35%。CGM 还显著降低了血清炎症标志物水平。结果表明，短期补充低剂量 CGM 比高剂量 CHN-GLN 联合治疗在缓解 OA 患者的疼痛和症状方面具有更好的有益效果。需要在更大的人群中进行更长时间的临床试验，以证实 CGM 在 OA 长期管理中的疗效。
