Investigating the Therapeutic Effect of Nigella Sativa in Male Genital Wart: A Randomized, Double-Blind Clinical Trial

This study is designed to evaluate the topical therapeutic effect of Nigella sativa oil on male anogenital warts in comparison with the standard 5% imiquimod treatment.

This study is a double-blind, randomized controlled trial with a sample size of 60 participants. Randomization will be performed using block and cluster randomization via the online randomization software, Research Randomizer.

This study will be conducted at the Papilloma Clinic of shahid Motahari Hospital. Eligible patients clinically diagnosed with genital warts by the infectious disease specialist will be enrolled after meeting the inclusion/exclusion criteria and providing written informed consent. both the participating patients and the infectious disease specialist responsible for patient examination and follow-up will be blinded to the type of treatment (intervention or placebo) administered to the patients.

Inclusion Criteria: 18 -60 male No past history of immune suppressive disease No concurrent sexually transmitted diseases Genital warts <1 cm diameter No prior the human papillomavirus vaccination

The intervention group applies Imiquimod 5% cream three times a week at night before sleep to the affected area, and after 8 hours the site is washed with water and soap. In addition, Nigella sativa oil is applied to the warts three times daily in the morning, at noon, and in the evening. The treatment continues until complete disappearance of the lesions or for a maximum of 16 weeks. For this purpose, the standardized Nigella sativa oil product of Barij Essence Company with the health code 6713905054496688 is used. The control group will similarly receive placebo until the end of the study.

Size of warty lesions, Number of warty lesions, Side effects

Patients will be allocated into two groups of 30 using block randomization with a block size of four. All six possible combinations of A and B will be considered, and the random allocation sequence will be generated by a statistician using Random Allocation Software. A randomization table will be prepared, and the principal investigator will be blinded to the allocation sequence. Participants will be assigned to intervention groups according to the randomization table in the order of enrollment.

This study will be conducted as a double-blind trial. The intervention drug (Nigella sativa oil) and the placebo (pharmaceutical-grade paraffin oil) will be identical in appearance, color, odor, volume, and packaging, and will be provided in identical containers labeled with anonymous codes. Coding of the study medications will be performed based on the random allocation table generated by a statistician, and the code list will be kept secure until completion of data analysis. Throughout the study, participants, the principal investigator, and all outcome assessors will remain unaware of the assigned intervention groups. Unblinding will be performed only after completion of data collection and final data analysis.