A Prospective, Open-label, Non-randomised Clinical Trial to Evaluate the Safety and Efficacy of Femiforte in the Treatment of Leucorrhoea

Abstract

Objectives: To evaluate the clinical efficacy and safety of Femiforte Tablets in Leucorrhoea. Materials and Methods: A prospective, interventional clinical study was conducted on 40 female patients, aged between 24-49 years, confirmed with leucorrhoea from clinical examination and who were willing to give informed consent. All patients received Femiforte Tablet at a dose of 1 tablet twice a day for 4 weeks. All patients were evaluated at baseline and 4 weeks for parameters of  malodor discharge, malodor discharge after intercourse, itching, dyspareunia, vaginal irritation, dysuria, lower abdominal pain; abnormal pH, bacterial vaginosis, trichomonas vaginitis and candidiasis; physician's and patient's global assessment at end of the study. Observation and Results: Femiforte Tablets reduced malodor discharge and malodor discharge after intercourse in 45% and 42.5% patients respectively, at the end of 4^th week from baseline. At the end of 4^th week, itching, dyspareunia and vaginal irritation had a reduction in 50%, 37.5% and 35% patients respectively, from baseline. At the end of 4^th week, dysuria and lower abdominal pain had a reduction in 15% and 30% patients respectively, from baseline. Conclusion: Femiforte Tablets produced a significant reduction in all the parameters associated with leucorrhoea, assessed after 4 weeks of treatment. In addition, a significant improvement in clinical global impression in efficacy and tolerability was also observed. No adverse events were reported by any patients. This indicates that Femiforte Tablet is clinically effective and safe in leucorrhoea.