To evaluate the efficacy and safety of Guominkang (GMK) for allergic rhinitis (AR).

A total of 130 patients with AR aged 18–60 were randomized 1:1 to the GMK or placebo groups for 8 weeks of treatment. Assessments were conducted every 4 weeks, followed by follow-up visits every 8 weeks during the 24-week follow-up period. The primary outcome was the change in total nasal symptom score (TNSS). Secondary outcome measures included related symptom scores, quality of life assessments, mental health scales and laboratory test results.

A total of 110 of the 130 participants completed the study at the Sixth People's Hospital of Nantong City, Nantong, China, between February and December 2023. After 8 weeks of treatment, the intention-to-treat (ITT) analysis showed a greater reduction in TNSS in the GMK group, with a score change of 9.00 (7.00, 10.00) and a difference (95% confidence interval [CI]) of − 9.00 (− 9.00 to − 8.00; P < .001). Consistent findings were confirmed in the per-protocol (PP) analysis, with a score change: 8.63 (2.37) and a difference (95% CI) of − 8.68 (− 9.51 to − 7.85; P < .001). The GMK group also showed marked improvements in total nasal and non-nasal symptom score (TNNSS), rhinoconjunctivitis quality of life questionnaire (RQLQ) scores and 36-item short form health survey (SF-36) (P < .001). Only Weed Pollen (wx5) showed a significant group–time interaction (P = .037). No serious adverse events or abnormal laboratory findings were observed.

GMK effectively relieves symptoms and improves quality of life of patients with AR. However, larger and longer-term trials are needed to further verify its efficacy and safety.