A multicenter, randomized, double-blind, placebo-controlled, parallel-group phase III clinical trial to assess the efficacy and safety of Yuping Tongqiao tablets in the treatment of persistent allergic rhinitis

ETHNOPHARMACOLOGICAL RELEVANCE: Yuping Tongqiao Tablets is a classic traditional Chinese medicine (TCM) formula commonly employed in China for managing various ailments, especially allergic conditions. Clinical reports indicate its potential as an effective treatment for persistent allergic rhinitis. Nevertheless, there remains a dearth of placebo-controlled studies to definitively establish its safety and efficacy. AIMS OF THE STUDY: Allergic rhinitis (AR) is a global health problem with an annually increasing prevalence and no radical cure to date. This study aimed to evaluate the efficacy and safety of Yuping Tongqiao tablets for the treatment of persistent allergic rhinitis and to provide a basis for using Chinese herbal medicine to treat AR. MATERIALS AND METHODS: This was a multicenter, randomized, double-blind, placebo-controlled study of patients with PAR. A total of 540 patients with PAR were randomly assigned to the test group (n = 360) or the placebo group (n = 180) at a 2:1 ratio. The clinical trial lasted for 4 weeks, evaluating various outcomes including total nasal symptom scores, rhinoconjunctivitis quality of life questionnaire (RQLQ) scores, traditional Chinese medicine (TCM) symptom scores and The incidence of adverse events. RESULTS: A total of 768 participants were enrolled, with 540 randomized and 516 successfully completed the research. The experimental group using Yuping Tongqiao tablets showed a significant reduction in TNSS, with the least squares mean of the average decrease being -2.56 points, compared to -1.74 points in the placebo group (p < 0.01). The experimental group exhibited a higher nasal symptom response rate at 4 weeks, substantial clinical improvements, and notable enhancements in TCM symptoms and RQLQ scores. Treatment efficacy increased with duration, and adverse events were mild-to-moderate and occurred at similar rates in both groups. CONCLUSION: Yuping Tongqiao tablets have been proven to be an effective and safe medication for the treatment of PAR. TRIAL REGISTRATION: ChiCTR, ChiCTR2200061367. Registered June 22, 2022.