Efficacy and safety of Liqingtong granules in the treatment of hyperuricemia: A randomized double-blind placebo-controlled pilot clinical trial

To investigate the efficacy and safety of Liqingtong (LQT) granules in patients with dampness-heat hyperuricemia. A randomized, double-blind, placebo-controlled pilot trial was conducted at the 983rd Hospital of the Joint Logistic Support Force of the People's Liberation Army from March 15, 2023, to August 10, 2023. In total, 119 participants were enrolled in this trial, and participants were given either LQT granules or placebo for 60 days based on a health education. The primary outcome was serum uric acid (SUA) level, and the secondary outcome was the traditional Chinese medicine (TCM) symptom score, measured on days 0, 30, and 60. Safety indicators, including liver function, kidney function, blood routine, glucose, blood lipid, blood pressure, and heart rate were tested on days 0 and 60 of the trial. The data were analyzed using Prism 9 software, and the significance level was set at P < .05. Among 119 participants, six in the LQT granule group and seven in the placebo group dropped out, and 106 participants completed clinical observation. Baseline information, including SUA levels, TCM symptom scores, and other clinical characteristics, did not differ between the groups. At the end of the trial, compared with baseline values, the SUA levels in the LQT granule group decreased ( P < .001), and no significant change was observed in the placebo group ( P = .422); compared with the placebo group, the SUA levels decreased in the LQT granule group ( P = .001). Compared with baseline values, the total TCM symptom scores in the LQT granule group decreased ( P < .001), with no change in the placebo group ( P = .136). Safety indicators did not differ significantly between the two groups. The pilot trial demonstrated the potential of LQT granules to lower SUA levels and improve symptoms of dampness and heat.