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IRCT20180115038383N1 IRCT 2018-02-08 Shahed University Effect of Leish G1 cream in leishmaniasis Evaluation Leish G1 cream efficacy on healing the cutaneous leishmaniasis 2018-02-04 anticipated 100 Complete https://irct.ir/trial/29057 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 3 Cutaneous Leishmaniasis. Intervention 1: Intervention group: Topical use of Leish G1 cream on leishmanial lesions twice daily for two months. The medication is a formulation of aquas garlic extract based on Eucerin, formulated in Behpad Teb Iranian laboratory and produced in Dineh Iran Industries complex. Intervention 2: Control group: Meglumine Antimonate intralesional injection once weekly. 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 Since this medication may needs further studies, we have no plan to publish raw data in this phase.
public Fateme Emadi
No 1471, North Kargar Street, Enghelab Squar
Teharn Iran (Islamic Republic of) 1417953842 +98 21 6646 4320 f.emadi@shahed.ac.ir Shahed University scientific Fateme Emadi
No 1471, North Kargar Street, Enghelab Squar
Teharn Iran (Islamic Republic of) 1417953842 +98 21 6646 4320 f.emadi@shahed.ac.ir Shahed University Iran (Islamic Republic of) Iran (Islamic Republic of) Patients with Cutaneous leishmaniasis approved by direct examinations Up to 5 lesions in each patient Duration of disease up to 3 months Patients who have not used anti leishmaniasis therapies 12 years 60 years Both Patients with facial lesions Patients with Lymphangitis lesions Patients with Immunodeficiency disorders Patients who use immunosuppressive drugs Patients with other skin diseases such as Eczema, Psoriasis and Lupus Patients with severe mental disorders such as Major Depressive Disorder and Psychosis Concomitant use of other medications Pregnancy or lactation B55.1 Cutaneous leishmaniasis Treatment - Drugs Treatment - Drugs Intervention group: Topical use of Leish G1 cream on leishmanial lesions twice daily for two months. The medication is a formulation of aquas garlic extract based on Eucerin, formulated in Behpad Teb Iranian laboratory and produced in Dineh Iran Industries complex. Control group: Meglumine Antimonate intralesional injection once weekly Wound healing. Timepoint: Evaluating size and grade of cutaneous lesion in days 0, 14, 28 and 60 aftertreatment. Method of measurement: Ruler. Behpad Teb Iranian Shahed University Behpad Teb Iranian Approved 2018-01-08 Ethics committee of ُShahed University of Medical Sciences Khalij Fars Freeway, across Imam khomeini shrine Tehran Tehran Iran (Islamic Republic of)