The effects of Nigella sativa L. Extract Ointment on Tumor Necrosis Factor (TNF)-α Levels in Postpartum women with Perineal Wounds: A Single-Blind Randomized Clinical Trial

TNF-α is a proinflammatory cytokine that has long been a research target because its sometimes uncontrolled increase in activity interferes with wound healing. Topical anti-inflammatory drugs currently on the market have local and systemic side effects. Nigella Sativa (NS) is one of the herbs that can improve wound healing by reducing TNF-α levels. The topical form, namely ointment, has been known to be effective in delivering extracts directly to the target. However, the benefits of NS in ointment form on TNF-α levels are unknown, which can improve perineal wound healing in postpartum women. The purpose of this study was to analyze the effect of 15% NS ointment on TNF-α levels in postpartum mothers with second-degree perineal wounds. This single-blind randomized pretest-posttest control group design was conducted in a health community center in Central Kalimantan, Indonesia, on 81 postpartum women with inclusion criteria of a history of childbirth <5x, day 1 postpartum, second-degree perineal wounds, and no complications during childbirth. Subjects were randomly divided into 15% NS ointment, 10% Povidone Iodine (PVP-I) ointment, and placebo groups. The ointment was applied to the perineal wound twice a day for seven days. The primary outcome was the level of TNF-α from venous blood serum on days 1 and 7 postpartum. Data were analyzed using IBM SPSS version 27 software. Results showed the mean of TNF-α levels of the study group at the pre-test (day 1) and post-test (day 7) were NS group (3.0±6.94) and (2.8±3.28), PVP-I group (7.2±9.98) and (5.4±9.17), placebo group (5.8±5.70) and (4.8±4.67). Independent-samples Kruskal-Wallis test showed that there was a difference in pre-test TNF-α levels (p=0.019), no difference in post-test TNF-α levels (p=0.056), no difference in delta TNF-α levels (p=0.494). Wilcoxon test showed no difference between measurements in all groups (p>0.05). The effect size of the 15% NS ointment was small on changes in TNF-α levels (r=0.1) compared to the control group. 15% NS ointment did not significantly reduce postpartum women's TNF-α levels but clinically produced a small effect. This study is key for further studies, which are needed to measure the effect of NS extract on postpartum maternal TNF-α levels using different interventions, durations, and doses.