Probe • Vol LXII • No. 3 • May–Aug 2023 • 9 Clinical Evidence 1 Efficacy and Safety of Septilin® Tablet in the Management of Respiratory Tract Infections Aim To evaluate the safety and efficacy of Septilin tablet in the management of upper and lower respiratory tract infections Materials and Methods This open clinical evaluation included 148 patients who attended the OPD of Bangalore Medical College (Bengaluru, Karnataka, India). Inclusion criteria In this study, adult patients of either sex, aged between 18 and 50 years, with upper and lower respiratory tract infections were included. Exclusion criteria Patients with severe psychiatric/cardiac, metabolic, gastrointestinal, or metabolic disorders; severe infections such as pneumonia, tuberculosis, status asthmaticus, and severe bronchospasm; and pregnant and lactating patients were excluded. Study procedure The number of patients with respiratory tract infections and the duration of illness are given in Table 1. Of the 148 patients with respiratory tract infections, 112 patients had upper respiratory tract infections (URTIs) such as tonsillitis, pharyngitis, rhinitis, laryngitis, and sinusitis, and 36 patients had lower respiratory tract infection (LRTI), that is bronchitis. All patients were physically examined; their ear, nose, throat, and chest were thoroughly examined; and their vitals, including respiratory rate, were recorded in case report forms. The patients were prescribed Septilin tablets at a dosage of 2 tablets, BID, for 6 weeks and were followed up at the end of the second, fourth, and sixth weeks for analyzing the presence of symptoms. The primary end points were clinical recovery from symptoms of URTIs and LRTIs, and the secondary end points were clinical safety and toxicity profile of Septilin tablet. Statistical analysis The study results were evaluated statistically using the Fisher’s exact test for the presence or absence of various signs and symptoms. Results The control of symptoms and gradual improvement in response to the treatment were noticed after 2 weeks, and further improvement was observed Table 2. Effect of Septilin Tablet on Respiratory Tract Infections Parameter At Entry Week 2 Week 4 Week 6 Tonsillitis 28 17 8a 3 Pharyngitis 24 8a 2b 0 Laryngitis 8 0 0 0 Sinusitis 20 12 7a 2b Rhinitis 32 2b 0 0 Bronchitis 36 20 11a 4b aP < .01 compared with at-entry values. bP < .001 compared with at-entry values. Table 1. The Number of Patients With Respiratory Tract Infections and the Duration of Illness Indication Patients, n Duration of Illness, d Respiratory Tract Infections 148 — Upper respiratory tract infections 112 — Tonsillitis 28 5.26 ± 2.5 Pharyngitis 24 7.23 ± 4.4 Laryngitis 8 7.58 ± 5.1 Sinusitis 20 5.3 ± 1.26 Rhinitis 32 7.47 ± 3.22 Lower respiratory tract infections 36 — Bronchitis 36 9.42 ± 3.41
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