The present trial was undertaken to study the pharmacological effects of a Unani Compound Formulation with inhalation of Kalonji and its safety in CRS patients. In this randomized, single-blind, standard controlled trial, 75 CRS patients were randomly allocated to three groups. In Group A, Unani oral compound formulation of Katan (Linum usitatissimum), Filfil Siyah (Piper nigrum) & Asl-e-Khalis (Honey)-6gm BD with steam inhalation of Kalonji (Nigella sativa), in Group B, the same oral formulation in same dose with steam inhalation, and in Group C, Tab Alaspan 1OD with Karvol Plus inhalation was given. Patients were investigated in the lab for haematological and safety parameters like CBC with ESR, AEC, IgE, LFT, and KFT before and after six weeks of treatment. The statistical analysis of the data generated was performed by using paired T-test. The results of the data of 60 patients who completed the study show that the test drug has statistically significant anti-inflammatory and antiallergic effects which help to resolve CRS. The formulation is safe as there was no statistically significant effect on safety parameters. The formulation has significant anti-inflammatory and anti-allergic effects in CRS patients. A multicentric trial of the test drug on larger sample size for a longer duration is required to establish the pharmacological effects of the formulation on CRS patients.
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