Efficacy and Safety Evaluation of Bresol Tablet in Allergic Rhinitis- A Double Blind Placebo Controlled Clinical Study

Allergic rhinitis (AR), often considered a trivial disease, is now increasingly being recognized as a cause of significant and widespread morbidity. It is the most common allergic disorder, affecting 10-20 percent of the population. Currently available therapeutic options in the management of AR have major limitations due to low clinical efficacy and associated adverse events. This study was planned to evaluate the clinical efficacy and safety (short- and long-term) of Bresol tablets in AR. The study was a placebo controlled, phase III clinical trial conducted as per the ethical guidelines of Declaration of Helsinki. One hundred subjects from the age group of 15 to 60 years who presented with symptoms of AR were included in the study. At the initial visit, a detailed medical history was obtained by interviewing the subjects, which was followed by thorough clinical examination and all the subjects were investigated by hematological and biochemical tests. Subjects were advised to consume one Bresol tablet, twice-daily for 4 weeks while subjects in placebo group received identical looking placebo in the same dose, for a period of 4 weeks. The predefined primary endpoints were proportion of subjects with rapid symptomatic control and clinical improvement, along with renormalization of laboratory parameters. The results were statistically analyzed by Mann Whitney test and Paired t test. The mean score sneezing, nasal congestion, itching of the eyes, itching of the nose, postnasal drip, rhinorrhea and watery eyes decreased significantly at the end of 4 weeks, when compared to the Placebo and respective baseline values. There was a significant reduction in the Total WBC Count, Neutrophils, Lymphocytes, Eosinophils, Monocytes, ESR and Absolute Eosinophil Count at the end of 4 weeks, when compared to the placebo group. There were no clinically significant adverse reactions, either reported or observed during the entire study period. The overall compliance to the treatment was good and no treatment discontinuations were reported. Therefore, it may be concluded that Bresol tablets are effective and safe in the management of AR.