Background <p>Nigella sativa possesses anti-inflammatory and immunomodulatory properties that may attenuate lung injury during infection. This study aimed to evaluate the adjunctive effect of oral Nigella sativa oil on the clinical course, inflammatory markers, and recovery parameters in children hospitalized with community-acquired pneumonia, assessing its potential anti-inflammatory and immunomodulatory benefits.</p> Methods <p>Between April 2023 and March 2024, 104 children with radiologically confirmed pneumonia were randomized to receive either standard institutional therapy plus oral Nigella sativa oil (<i>n</i> = 52) or standard therapy alone (<i>n</i> = 52). Primary endpoints were time to clinical stability, defined by normalization of respiratory rate, oxygen saturation ≥ 95% on room air, and resumption of oral feeding. Secondary endpoints included changes in inflammatory and tissue injury biomarkers [white blood cell count, C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), lactate dehydrogenase (LDH)].</p> Results <p>The study included children with a mean age of 4.76 ± 2.58 years, with males comprising 57.69% (<i>n</i> = 60) of the participants. Compared with controls, the Nigella sativa group achieved faster normalization of respiratory rate (<i>p</i> &lt; 0.001), earlier recovery of oxygen saturation (<i>p</i> = 0.001), and earlier resumption of oral feeding (<i>p</i> = 0.013). Significant reductions in WBC (<i>p</i> = 0.036), CRP (<i>p</i> = 0.023), ESR (<i>p</i> = 0.001), and LDH (<i>p</i> = 0.027) were observed. No adverse effects were reported.</p> Conclusion <p>Adjunctive oral Nigella sativa oil supplementation was associated with faster clinical recovery and improved inflammatory profiles in children with pneumonia.</p> Clinical trial registration <p>ClinicalTrials.gov (Identifier: NCT05952102), First submitted and met quality control criteria on July 11, 2023; first posted publicly on July 19, 2023.</p>