Objective: To establish the efficacy of the oral Unani formulations with inhalation of Kalonji in comparison with the standard control in Iltehab Tajaweefe Anaf Muzmin (Chronic Rhinosinusitis [CRS]) based on the computed tomography (CT) paranasal sinuses (PNS) findings. To provide safe, effective, and economical treatment for Iltehab Tajaweefe Anaf Muzmin. Methods: In this randomized, single-blind, standard-controlled study of 45 patients with CRS, the patients were allocated to two groups. In Group A, patients received Unani oral formulation: Katan (Linum usitatissimum), Filfil siyah (Piper nigrum), and Asl-e-Khalis in a 6 g BD dose with steam inhalation of Kalonji (Nigella sativa) BD and Tab Alaspan 1OD with Karvol Plus inhalation BD in Group B. Statistical data was analyzed using a paired-t test by comparing the total sinus score (TSS) of CT PNS calculated based on the Lund Mackay staging system before and after treatment. Results: The result is statistically significant in Group A in comparison to the non-significant effect in Group B (p<0.05). After treatment, there was a 30% complete resolution of the TSS in CT PNS imaging in group A, in comparison to the 0% complete resolution of the TSS in group B. No adverse effects were reported during the study. Conclusion: The oral Unani formulation with inhalation of Kalonji is safe and has a statistically significant effect on TSS (CTPNS) in patients with CRS in Group A. A multicentric trial of the test drug on a larger sample size for a longer duration is required to establish the efficacy of the Inkebab of Kalonji with oral Unani formulation on patients with CRS.
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