Efficacy and safety of Qing Zhu Granules for acute gouty arthritis with dampness-heat obstruction syndrome: study protocol for a phase 3, multicenter, randomized, double-blind, placebo-controlled trial.

UNLABELLED: Although standard therapies for acute gouty arthritis, such as nonsteroidal anti-inflammatory drugs, colchicine, and glucocorticoids demonstrate efficacy, their clinical application is limited by potential adverse reactions, which remains an unresolved issue. Qing Zhu Granules is a traditional Chinese medicine (TCM) compound preparation used for the treatment of primary acute gouty arthritis with dampness-heat obstruction syndrome. This multicenter, randomized, double-blind, placebo-controlled phase 3 clinical trial conducted in China aimed to evaluate the efficacy and safety of Qing Zhu Granules. Patients who met the Western medical diagnostic criteria for gout, met the TCM syndrome differentiation criteria for dampness-heat obstruction syndrome, had an acute attack duration ≤48 h, and a visual analog scale (VAS) score of joint pain ≥ 40 mm in the current attack were included. Participants were randomly assigned in a 1:1 ratio to the Qing Zhu Granules group or the placebo group, with an oral dose of 6 g, administered 3 times a day, for a treatment course of 3 days. During the treatment period, diclofenac sodium enteric-coated tablets could be used as rescue medication in case of intolerable pain. The primary endpoint was the change in joint pain VAS score (0-100 mm) from baseline at 72 h after treatment. The secondary endpoints included changes in joint pain VAS score from baseline at 24 and 48 h after treatment, changes in the total score and each individual item score of the TCM syndrome rating scale from baseline, changes in C-reactive protein levels from baseline at 72 h after treatment, total dose and frequency of rescue medication within 72 h of treatment, and the interval between the first use of rescue medication and the first use of the study drug after treatment initiation.

CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/, identifier NCT06068478.