An open label, non-controlled, multicentre, interventional trial to investigate the safety and efficacy of Canephron® N in the management of uncomplicated urinary tract infections (UUTIs)

Study design. An open label, non-randomized, multicentre clinical trial. Purpose of the study. Efficacy and safety of Canephron® N in the management of women with uncomplicated urinary tract infections. Introduction. Despite of increasing prevalence of bacterial resistance to antibiotics and possible adverse drug reactions, uncomplicated lower urinary tract infections are usually treated with antibiotics. Canephron® N, a herbal medicinal product, was investigated for safety and efficacy in women suffering from uncomplicated urinary tract infections. Methods. The study included 125 patients suffering from uncomplicated urinary tract infections. Cases with the sum score of at least 6 for the symptoms of dysuria, frequency and urgency were enrolled. Patients were treated with 3.2 tablets Canephron® N for 7 days. Symptom assessment was performed by the patient on a daily basis and by the investigator at Day 0, Day 7 and Day 37. Incidence of adverse drug reactions during the treatment was considered as primary endpoint; clinical cure on Day 7, severity of uncomplicated urinary tract infections symptoms on Day 7 and Day 37, patients requiring antibiotic treatment until Day 7, duration of uncomplicated urinary tract infections symptoms and patients with early recurrence - as secondary endpoints. Changes in laboratory parameters were also analyzed. Results. None of the 19 adverse reactions reported in the study was not associated with the use of the drug and not characterized as "serious". The response rate was 90.4% and 93.6% on Day 7 and Day 37 with a significant improvement of all symptoms (p<0.001). Only 2.4% of patients required antibiotics during the treatment. None of the patients met the definition of recurrence until Day 37. The mean changes of the main symptoms on Day 7 and Day 37 compared to Day 0 were: -1.9/-2.3 (dysuria); -1.8/-2.4 (frequency); -1.6/-1.9 (urgency). Decreased nitrite, leukocytes as well as erythrocyte levels accompanied symptomatic improvement from Day 0 to Day 7 and Day 37. Conclusion. The study confirmed the safety and efficacy of the Canephron® N without antibiotics.

Canephron® N, uncomplicated urinary tract infections, herbal drug, clinical trial, safety, efficacy