A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for Evaluation of the Efficacy and Safety of DKB114 on Reduction of Uric Acid in Serum

Abstract

This study sought to investigate the antihyperuricemia efficacy and safety of DKB114 (a mixture of Chrysanthemum indicum Linn flower extract and Cinnamomum cassia extract) to evaluate its potential as a dietary supplement ingredient. This clinical trial was a randomized, 12-week, double-blind, placebo-controlled study. A total of 80 subjects (40 subjects with an intake of DKB114 and 40 subjects with that of placebo) who had asymptomatic hyperuricemia (7.0–9.0 mg/dL with serum uric acid) was randomly assigned. No significant difference between the DKB114 and placebo groups was observed in the amount of uric acid in serum after six weeks of intake. However, after 12 weeks of intake, the uric acid level in serum of subjects in the DKB114 group decreased by 0.58 ± 0.86 mg/dL and was 7.37 ± 0.92 mg/dL, whereas that in the placebo group decreased by 0.02 ± 0.93 mg/dL and was 7.67 ± 0.89 mg/dL, a significant difference (p = 0.0229). In the analysis of C-reactive protein (CRP) change, after 12 weeks of administration, the DKB114 group showed an increase of 0.05 ± 0.27 mg/dL (p = 0.3187), while the placebo group showed an increase of 0.10 ± 0.21 mg/dL (p = 0.0324), a statistically significant difference (p = 0.0443). In the analysis of amount of change in apoprotein B, after 12 weeks of administration, the DKB114 group decreased by 4.75 ± 16.69 mg/dL (p = 0.1175), and the placebo group increased by 3.13 ± 12.64 mg/dL (p = 0.2187), a statistically significant difference between the administration groups (p = 0.0189). In the clinical pathology test, vital signs and weight measurement, and electrocardiogram test conducted for safety evaluation, no clinically significant difference was found between the ingestion groups, confirming the safety of DKB114. Therefore, it may have potential as a treatment for hyperuricemia and gout. We suggest that DKB114 as a beneficial and safe food ingredient for individuals with high serum uric acid. Trial registration (CRIS.NIH. go. Kr): KCT0002840.

The Stiff Joint: Comparative Evaluation of Monotherapy and Combination Therapy With Urate Lowering Agents in Managing Acute Gout

“…By obstructing URAT1, the combination enhances the overall rate of urate excretion while simultaneously lowering serum urate concentrations. Furthermore, the combined therapy also hampers OAT4, an organic anion transporter implicated in luminal urate reabsorption, which is linked to diuretic-induced hyperuricemia [29,[31][32][33][34][35][36].…”

“…This combination provides a dual mechanism for lowering serum urate levels: it inhibits renal urate reabsorption and subsequently reduces urate production. Notably, the lesinurad-XOI combination effectively targets URAT1, a uric acid transporter, contributing to increased urate anion reabsorption within renal tubules [ 29 , 30 ]. By obstructing URAT1, the combination enhances the overall rate of urate excretion while simultaneously lowering serum urate concentrations.…”

“…Specifically, when lesinurad was administered at 200mg alone, serum urate levels exhibited an average decrease of approximately 46% and 26% at 6-hours and 24 hours post-dosage, respectively [ 30 , 31 ]. However, when lesinurad (200mg) was administered in combination with an XOI, an additional reduction of 25% and 19% in serum urate levels was observed at 6 and 24 hours post-dosage, respectively [ 29 , 31 ]. These findings were further substantiated by pivotal studies, which are discussed in more detail below.…”