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IRCT20130311012782N46 IRCT 2020-05-25 Mashhad University of Medical Sciences effect of adding Cyprofloxacin ointment in treatment of Lishmaniasis Study of the additional effect of topical ciprofloxacin on intralesional injection of glucantime in the treatment of cutaneous leismaniasis 2020-08-21 anticipated 52 Complete https://irct.ir/trial/48276 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization of patients between the two groups is done by Random Allocation Software. In the mentioned software, the volume of the total sample size and the number of groups are entered to the software. The randomization unit in the mentioned software is individual. The software output is a grouped list that randomly distributes the number of samples in two groups. According to the list, patients are distributed in two groups according to the time of referral so that the sample size reaches the required number in each group, Blinding description: The study is conducted in double blind forms. Patients are unaware of the contents of the topical ointment received. In this way, the medicine is prepared by one of the staff of the clinic who is not in the process of studying in the same packaging and is given to the project executor for prescribing to the patients. Data collection work is also performed by an infectious disease specialist who is unaware of the type of prescription ointment. 3 Cutaneous Lishmaniasis. Intervention 1: Intervention group: In this group treated with topical ointment ciprofloxacin liposomes twice a day with a weekly injection of glucocorticoids into the lesion for 8 weeks. Then the size of the lesion (induction) at the time before and 1.5 month after will be evaluated. Intervention 2: Control group: In this group treated with placebo of topical ointment twice a day with a weekly injection of glucocorticoids into the lesion for 8 weeks. Then the size of the lesion (induction) at the time before and 1.5 month after will be evaluated. No - There is not a plan to make this available Justification or reason for not sharing IPD is The plan belongs to the government agency and cannot be published
public Javad Yazdanpanah
Department of infectious diseases, Ghaem hospital, ghaem street, Mashhad, Iran
Mashhad Iran (Islamic Republic of) 8434193474 +98 51 3669 2174 yazdanpanahmj@mums.ac.ir Mashhad University of Medical Sciences scientific Mohamadjavad Yazdanpanah
Department of Infectious diseses, Ghaem hospital, Mashhad, Iran
Mashhad Iran (Islamic Republic of) 8434193474 +98 51 3800 2109 yazdanpahnahmj@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Having a Lishmaniasi with direct smear confirmation The clinical course of the lesion is less than 6 months No history of leishmaniasis treatment 2 months before entering the study 18 years 70 years Both Pregnancy and lactation Use of other therapies during the study period Specific forms of leishmaniasis, such as erysipeloid, zosteriform, vasoprotective, and lopoid B55.1 Cutaneous leishmaniasis Treatment - Drugs Treatment - Drugs Intervention group: In this group treated with topical ointment ciprofloxacin liposomes twice a day with a weekly injection of glucocorticoids into the lesion for 8 weeks. Then the size of the lesion (induction) at the time before and 1.5 month after will be evaluated. Control group: In this group treated with placebo of topical ointment twice a day with a weekly injection of glucocorticoids into the lesion for 8 weeks. Then the size of the lesion (induction) at the time before and 1.5 month after will be evaluated. Improvement status. Timepoint: Every week for 8 weeks. Method of measurement: Physical examination. Improvement time. Timepoint: Every week for 8 weeks. Method of measurement: Physical examination. Size of scare. Timepoint: Ent of treatment. Method of measurement: Physical examination. Mashhad University of Medical Sciences Approved 2020-05-18 Ethics committee of Mashhad University of Medical Sciences Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghaem Street , Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)