Objective  To evaluate the efficacy and safety of Relinqing granules in the treatment of acute uncomplicated urinary tract infection (damp heat in the lower jiao pattern) in females.

Methods  A multicenter, randomized, double-blind, double-dummy, positive-drug parallel-controlled, non-inferiority clinical trial was conducted. Female patients with acute uncomplicated urinary tract infection (damp heat in the lower jiao pattern) admitted to nine centers between June 30, 2017, and August 6, 2018, were enrolled and randomly assigned to the experimental group (Relinqing granules + ciprofloxacin hydrochloride tablets simulant) or the control group (Relinqing granules simulant + ciprofloxacin hydrochloride tablets). Treatment lasted for 5 days, followed by a 4-week follow-up period. The cure rate served as the primary efficacy outcome. Other efficacy outcomes included bacterial clearance rate, comprehensive recovery rate, and recurrence rate. Safety was assessed by monitoring the occurrence of adverse reactions.

Results  A total of 191 patients were enrolled, with 97 patients in the experimental group and 94 patients in the control group. The cure rates were 71.88% (69/96) in the experimental group and 76.34% (71/93) in the control group, with no statistically significant differences (P=0.377). The non-inferiority test showed that the lower limit of the 95% confidence interval (CI) for the difference in clinical cure rates between the experimental and control groups was -16.94%, which did not meet the pre-specified non-inferiority margin of -10%. Among patients with moderate severity, the cure rates were 70.45% (31/44) in the experimental group and 51.52% (17/33) in the control group, showing no statistically significant difference (P=0.090); however, the non-inferiority test supported the non-inferiority of the experimental group (lower limit of 95% CI: -2.80%>-10%). No statistically significant differences were observed between the two groups in bacterial clearance rate, comprehensive recovery rate, or recurrence rate of clinical outcomes (P>0.05). The incidences of adverse drug reactions were 3.13% (3/96) in the experimental group and 5.38% (5/93) in the control group, with no statistically significant difference (P=0.684). No serious adverse reactions occurred in the experimental group.

Conclusion Based on the full analysis set analysis which is closer to clinical practice, the clinical cure rate of Relinqing granules in the treatment of female acute uncomplicated urinary tract infection (damp heat in the lower jiao pattern) was similar to that of ciprofloxacin hydrochloride tablets, but did not reach the preset non-inferiority standard. In patients with moderate disease, the clinical cure rate of Relinqing granules was higher than that of ciprofloxacin hydrochloride tablets, and showed a non-inferior trend. Relinqing Granules have good safety, low incidence of adverse reactions, and no serious adverse reactions occur, and the risk is controllable.

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