Safety and effectiveness of Ditong liquid nasal spray in patients with acute rhinitis

GAO Chun-sheng; WU Wei; LIU Da-xin; ANGQING Cai-dan; WANG Zhong-yan

Abstract：Objective:To investigate the safety and effectiveness of Ditong liquid nasal spray in the treat-ment of symptoms of cold and stuffy noses (acute rhinitis). Methods:In a randomized, blinded, parallel con-trolled, multi-center safety/efficacy study, 88 patients with symptoms of cold and stuffy noses were enrolled. The patients were treated by either Ditong liquid nasal spray, 1～2 squirts in each nostril, 3～4 times daily for 5 days (n=66), or rhinitis drop (spray) 1～2 squirts in each nostril, 3～4 times daily for 5 days (control, n=22). Primary outcome measures were based on cold and stuffy noses clinical efficacy criterion; nasal symptoms, total change in symptoms and remission/duration time of stuff noses were observed. Secondary outcome measures were general physical examination, safety assessment (adverse events) and clinical measurements. Results:Of the 88 patients, the full recovery rate, partial recovery rate, effective rate and ineffective rate were 24.24%, 31.82%, 37.88% and 6.06% in Ditong group, and 4.55%, 36.36%, 36.36% and 22.73% in control group, respective-ly. The overall effectiveness of Ditong was significantly better than control (P<0.05). However, the difference in remission time of stuff nose between two groups was not significant as analyzed by rank sum test but was significant by t test (P<0.05). There was no significant difference in temperature,respiration, heart rate, systolic pressure, diastolic pressure between before and after treatment. No obvious adverse effects were found in both groups. Con-clusion:Ditong nasal spray is effective and safe in the treatment of cold and stuff nose (acute rhinitis).