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IRCT20170723035248N4 IRCT 2020-10-09 Ghoum University of Medical Sciences Comparison of the efficacy of glucantime and cryotherapy simultaneously and cryotherapy alone in the treatment of cutaneous leishmaniasis A Comparative assessment of topical Glucantime® injection plus cryotherapy, and cryotherapy alone for Treatment of Anthroponotic cutaneous leishmaniasis 2013-03-20 anticipated 476 Complete https://irct.ir/trial/50942 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this research, block randomization method will be used for random allocation. The blocks size will be 4 and for this purpose, 25 blocks with 4 subjects in each block will be used. the combination of all patterns will be considered including AABB, ABAB, BABA, BBAA, BABA, BAAB. For selecting each blocks, ِDice drooped and the bloc number will be selected. this procedure continued to completed the allocation and reached to sample size. 3 Cutaneous leishmaniasis. Intervention 1: cryotherapy simultaneously with intralesional injection of Glucantime®. Intervention 2: Intervention group: cryotherapy alone. Yes - There is a plan to make this available What will be shared: Medical records When: Access period starts one month after the results are published. To whom: public Conditions: Unconditional. Where to obtain: Abedin Saghafipour - Faculty of Health, Qom University of Medical Sciences, Qom, Ruhollah Square, next to the Blood Transfusion Organization, Faculty of Health, Room 16 Phone: 09124397413 Email address: abed.saghafi@yahoo.com How to obtain: Unconditional. Comments:
public Abedin Saghafipour
No. 17, Mellat St., Behesht Blvd., Pardisan City
Qom Iran (Islamic Republic of) 3711675549 +98 25 3281 3151 abed.saghafi@yahoo.com Ghoum University of Medical Sciences scientific Abedin Saghafipour
No. 17, Mellat St., Behesht Blvd., Pardisan Town
Ghoum Iran (Islamic Republic of) 3711675549 +98 25 3281 3151 abed.saghafi@yahoo.com Ghoum University of Medical Sciences Iran (Islamic Republic of) Criteria for joining the study include age over one year Onset of disease in less than 4 weeks. 1 year no limit Both Criteria for withdrawing from the study include use of antibiotics or other antimicrobial drugs for leishmaniasis in the past 4 weeks Extensive lesions with a diameter of more than 5 cm and more than 3 lesions on the patient's body. B55.1 Cutaneous leishmaniasis Treatment - Drugs Treatment - Drugs cryotherapy simultaneously with intralesional injection of Glucantime® Intervention group: cryotherapy alone En measuring surface of healed tissue of people with cutaneous leishmaniasis. Timepoint: Six weeks after the last treatment in both groups, skin lesions are assessed. Method of measurement: Calibrated ruler. Elimination of inflammatory symptoms and tissue hardness and healing of papules and ulcers are considered as complete recovery. Timepoint: Six weeks after the last treatment. Method of measurement: Calibrated ruler. Ghoum University of Medical Sciences Approved 2020-09-15 Ethics committee of Qom University of medical Sciences, Bam, Iran Safa Shahr street, Jahad Daneshgahi street., alley 4, Qom Ghoum Iran (Islamic Republic of)