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IRCT20190624043991N21 IRCT 2023-11-12 Tehran University of Medical Sciences Investigating the effect of zinc nanoparticles on the transmission of HPV infection Investigating the effect of zinc nanoparticles on the transmission of HPV infection from a person infected with HPV virus 2024-03-05 anticipated 70 Complete https://irct.ir/trial/73290 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomization, the balanced block randomization method is used to generate blocks with size of 4. Intervention group A and control group B have been determined. According to the randomization method, we expect the two groups to differ by a maximum of 2 people in terms of the number of people assigned. After the methodologist prepares the randomization sequence using the Sealdenvelop online site, the generated sequence will be available to a technician outside the research team. blocks (A or B) are placed in envelopes. After the arrival of the first patient with the inclusion criteria, the envelopes are randomly selected, and the type of patient group is informed to the research team through a trained technician. Based on the randomly selected envelope, the patient is placed in the group (Double G plus placebo: 30 patients) or (Double G plus theophylline: 30 patients), Blinding description: The present study is a double-blind, randomized clinical trial. The researcher and the participant will not know about the randomization method. The present study is a double-blind, randomized clinical trial study. The researcher and the participant will not know how to be placed in the control or intervention groups. In both groups, the same ointment made by Bonyakhte company is used. The first group is an ointment containing zinc oxide nanoparticles ، The Second group is a placebo ointment that does not contain any nanoparticles. 3 Genital warts in the genitals of men. Intervention 1: Intervention group: Sample of human papillomavirus, 5 minutes after using the ointment containing zinc oxide nanoparticles, 25% (every 100 grams contains 25 groups of drugs), Bonyakhte Technology Company, use it once on the wart and then take a sample. Intervention 2: Control group: human papillomavirus sample, 5 minutes after topical application of placebo ointment on the wart (Vaseline ointment that does not contain any nanoparticles and is used only to avoid the confounding effect in the study)، Bonyakhte Technology Company, use it once on the wart and then take a sample. Yes - There is a plan to make this available What will be shared: Demographic information anonymously When: One year after publication To whom: Researchers working in academia, physicians, surgeons and hospitals Conditions: Any analysis can be done with the consent of the main researcher Where to obtain: Sina Hospital, Urology Research Center, Head of Urology Research Center: Dr. Seyed Mohammad Kazem Aghamir 00982166348560 mkaghamir@tums.ac.ir How to obtain: After reviewing the information by the administrator and epidemiologist, the patient information will be available for the applicant by the provision of a patient's privacy. Comments:
public Dr Akram Mirzaei
Urology Research Center- Sina Hospital - Imam Khomeini St
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6634 8560 mirzaee.scholar@gmail.com Tehran University of Medical Sciences scientific Dr Mohammad Kazem Aghamir
Urology Research Center- Sina Hospital - Imam Khomeini St
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6634 8560 mkaghamir@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Men in the age range of 18 to 60 years who have prominent genital warts Obtaining informed consent from patients 18 years 60 years Male Men who have received the Gardasil vaccine according to the previous indications A63.0 Anogenital (venereal) warts Treatment - Drugs Placebo Intervention group: Sample of human papillomavirus, 5 minutes after using the ointment containing zinc oxide nanoparticles, 25% (every 100 grams contains 25 groups of drugs), Bonyakhte Technology Company, use it once on the wart and then take a sample. Control group: human papillomavirus sample, 5 minutes after topical application of placebo ointment on the wart (Vaseline ointment that does not contain any nanoparticles and is used only to avoid the confounding effect in the study)، Bonyakhte Technology Company, use it once on the wart and then take a sample. The use of zinc oxide nanoparticles on HPV transmission. Timepoint: Before and 5 minutes after topical application of the ointment. Method of measurement: Molecular diagnosis laboratory (Real Time PCR ). Tehran University of Medical Sciences Approved 2023-05-22 Ethics Committees in Medical Medical Research Room 604, Sixth Floor, Central Staff Building, Tehran University of Medical Sciences, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)