This clinical study was carried out to evaluate the efficacy and safety of ALM16 as a new functional raw material for joint health improvement. The clinical study was designed as a single institution, randomized, double-blind, placebo-controlled, and comparative study [1]. In this study, 88 patients with mild and moderate degenerative arthritis were treated with ALM16, the test product, for 12 weeks, three times a day (for a total of 9 tablets per day). In the animal studies, ALM16 exhibited excellent cartilage protection efficacy. The primary endpoint was the change of 100mm Pain VAS on walking (VAS) at the evaluation point (visit 4) after 12 weeks compared to baseline (visit 2). In the secondary endpoint, the change rate of VAS and WOMAC Scale (WOMAC), Korean Knee Score (KKS), and cytokines were evaluated. In the secondary endpoint, the test group showed a statistically significant improvement of 44.73% (p-value < 0.0001) at the score change rate of VAS before and after the test food intake, while there was no statistically significant difference in the control group. In the total score change rate of WOMAC, the test group and control group showed statistically significant improvements of 38.18% (p-value < 0.0001) and 18.95%, respectively, before and after the test food intake. The total score change rate of KKS in test group showed a statistically significant improvement of 35.76% (p-value < 0.0001); whereas the change in the TNF-alpha, Interleukin-6, and CRP (C-reactive protein) showed some improvement in the test group, although there was no statistical significance. The results suggest that ALM16 has statistically and clinically significant improvement effects in moderate degenerative arthritis patients diagnosed with knee pain of Kellgren-Lawrence grades I-III [2] in radiological examinations.
[1] Kloppenburg M. et al., Osteoarthritis Cartilage 2015; 23:772-786.
[2] Spector TC, Cooper C. Osteoarthritis Cartilage 1993; 1(4): 203–206.