role of bresol tablet in allergic rhinitis: a clinical safety and efficacy study
Aditi Chaudhuri,A. DAS,B.PAKHIRA
Published in International Journal of Advanced Research in Medical Science
ISSN: xxxx-xxx Impact Factor:xx Volume:1 Issue:1 Year: 25 August,2014 Pages:1-14
Abstract
Allergic rhinitis (AR) is now increasingly being recognized as a cause of significant and widespread morbidity affecting 10-20 percent of the population. Currently available therapeutic options in the management have major limitations due to unmet clinical efficacy and associated adverse events. This study was planned as an open clinical trial to evaluate the clinical efficacy and safety (short- and long-term) of Bresol tablets in AR. Forty nine subjects of either the sex in the age group of 21 to 50 years who presented with symptoms of AR were included in the study after obtaining the informed written consent. Subjects suffering from severe systemic comorbid illness, which necessitated the use of other medications, were excluded from the study. On inclusion into study, a detailed medical history, thorough clinical examination and hematological and biochemical investigations were carried out. Subjects were advised to consume one Bresol tablet, twice-daily for 2 weeks. The predefined primary endpoints were clinical improvement, as well as renormalization of laboratory parameters. The predefined secondary endpoints was to evaluate the incidence of adverse events and overall compliance to the drug therapy. Statistical analysis was performed as per the intention-to-treat principle for all efficacy parameters. The mean score for sneezing, nasal congestion, itching of nose, postnasal drip, rhinorrhea, cough, wheezing and watery eyes were decreased significantly at the end of 2 weeks, when compared to their respective baseline values. There was a highly significant reduction in the Total WBC Count, Neutrophils, Lymphocytes, Eosinophils, Monocytes and ESR at the end of 2 weeks, when compared to their respective baseline values. 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.
Kewords
Bresol, Allergic Rhinitis, Open clinical trial
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