]>
IRCT20251103067866N1 IRCT 2026-01-25 Iran University of Medical Sciences Investigating the Effect of Nigella Sativa in Male Genital Wart Investigating the Therapeutic Effect of Nigella Sativa in Male Genital Wart: A Randomized, Double-Blind Clinical Trial 2026-04-20 anticipated 60 Recruiting https://irct.ir/trial/87280 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Genital Wart. Intervention 1: The intervention group applies imiquimod 5% topically three times per week on alternate nights before bedtime. The application area is washed with soap and water approximately 8 hours later. Additionally, they use black seed oil three times a day – in the morning (after washing off the imiquimod), at noon, and in the evening .Patients are advised to apply a thin layer of the standardized black seed oil product (Barij Essence Company, health code: 6713905054496688) on the volar surface of the forearm 24 hours prior to initiating treatment. The application site should be monitored for signs such as redness, itching, burning, or swelling. If local adverse effects occur, the patient will be withdrawn from the study (and replaced by another participant) and will receive appropriate guidance for further management. The treatment continues until complete disappearance of the lesions or for a maximum of 16 weeks. Intervention 2: The control 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, instead of Nigella sativa oil, the placebo is applied three times daily in the morning, at noon, and in the evening after the lesion site has been cleaned of the 5% Imiquimod cream, that is, in the morning after washing the area, and at noon and in the evening, to the wart. The placebo is prepared with pharmaceutical-grade paraffin oil by Barij Essence Company. Patients are advised to apply a thin layer of the placebo product on the anterior forearm 24 hours before starting treatment and examine the area for symptoms such as redness, itching, burning, and swelling. In case of local adverse reactions, the patient will be excluded from the study (and replaced with another person), and the necessary guidance will be provided for continuation of treatment. The treatment continues until complete disappearance of the lesions or for a maximum of 16 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is there are not more informations
public Mozaffar Rezvani Zadeh
No. 18, Astaneh St, Hadi Saei Sq, Qum St,.
Rey Iran (Islamic Republic of) ۱۸۷۶۷۳۳۵۸۷ +98 21 5597 3051 mozaffar.rezvani.72@gmail.com Iran University of Medical Sciences scientific Mozaffar Rezvani Zadeh
No. 18, Astaneh St, Hadi Saei Sq, Qum St,.
Rey Iran (Islamic Republic of) ۱۸۷۶۷۳۳۵۸۷ +98 21 5597 3051 mozaffar.rezvani.72@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) 18 -60 male No past history of immune suppressive disease No concurrent sexually transmitted diseases Genital warts <1 cm diameter No prior human papillomavirus vaccination 18 years 60 years Male People with a history of allergy to Nigella Sativa A63.0 Anogenital (venereal) warts Treatment - Drugs Treatment - Drugs The intervention group applies imiquimod 5% topically three times per week on alternate nights before bedtime. The application area is washed with soap and water approximately 8 hours later. Additionally, they use black seed oil three times a day – in the morning (after washing off the imiquimod), at noon, and in the evening .Patients are advised to apply a thin layer of the standardized black seed oil product (Barij Essence Company, health code: 6713905054496688) on the volar surface of the forearm 24 hours prior to initiating treatment. The application site should be monitored for signs such as redness, itching, burning, or swelling. If local adverse effects occur, the patient will be withdrawn from the study (and replaced by another participant) and will receive appropriate guidance for further management. The treatment continues until complete disappearance of the lesions or for a maximum of 16 weeks. The control 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, instead of Nigella sativa oil, the placebo is applied three times daily in the morning, at noon, and in the evening after the lesion site has been cleaned of the 5% Imiquimod cream, that is, in the morning after washing the area, and at noon and in the evening, to the wart. The placebo is prepared with pharmaceutical-grade paraffin oil by Barij Essence Company. Patients are advised to apply a thin layer of the placebo product on the anterior forearm 24 hours before starting treatment and examine the area for symptoms such as redness, itching, burning, and swelling. In case of local adverse reactions, the patient will be excluded from the study (and replaced with another person), and the necessary guidance will be provided for continuation of treatment. The treatment continues until complete disappearance of the lesions or for a maximum of 16 weeks. Size of warty lesions. Timepoint: Before and after the completion of the intervention. Method of measurement: The primary outcome is assessed clinically and documented by measuring size changes using a ruler. Number of warty lesions. Timepoint: Before and after the completion of the intervention. Method of measurement: Lesions are observed and counted through clinical examination. Side effects. Timepoint: Before the intervention and 2 weeks after the completion of the intervention. Method of measurement: Yellow form for reporting adverse drug reactions. Iran University of Medical Sciences Approved 2025-09-17 The Ethics Committee of Iran University of Medical Sciences Iran University of Medical Sciences, Hemmat Highway Tehran Tehran Iran (Islamic Republic of)