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Background: Diabetic neuropathy is one of the most common complications of diabetes. The synthetic drugs available in the market have side effects and limitations for diabetic patients, the vast majority of whom are in the upper age group. In this regard, based on Persian medicinal sources, Nigella sativa (N. sativa) has proved to have beneficial effects on neuropathic pain and neurological disorders. In this study, the effect of N. sativa is investigated topically in patients with diabetic neuropathy. Methods: This study was performed as a double-blind clinical trial on 120 neuropathic patients. The patients were divided into three groups. The first group received a topical N. sativa product as an ointment, the second group was given a topical placebo, and the third received 300 mg gabapentin capsules. The blindness was done in first and second groups. Diabetic neuropathy was assessed before the study using the Michigan Neuropathy Screening Instrument (MNSI). In addition, neuropathy symptoms were evaluated after the trial using the MNSI questionnaire. Results: The data were elicited from the patients' answers to a number of questions in the Michigan questionnaire. There were statistically significant differences between the group that received the topical N. sativa product and the other two groups in terms of legs and feet numbness (p value = 0.001), burning pain in feet or legs (p value = 0.001), muscle cramps in feet or legs (p value = 0.001), prickling fleeing in feet or legs (p value = 0.001), hurting of the skin when the bed covers touch it (p value = 0.005), aggravated symptoms at night (p value = 0.001) and hurting feelings in the legs when walking (p value = 0.032). However, the three studied groups were not statistically different in distinguishing hot water from cold water. Conclusion: According to the results of this study, the topical use of N. sativa, compared to the current drugs, has acceptable improving effects on diabetic neuropathic patients. [ABSTRACT FROM AUTHOR]