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IRCT2017060117756N16 IRCT 2017-06-02 Vice-chancellery for Research of Mashhad University of Medicla Sciences Comparing the effects of intralesional Meglumine Antimonate injection alone and intralesional Meglumine Antimonate injection plus local barberry root extract in cutaneous leishmaniosis treatment A comparative study of the effects of intralesional Meglumine Antimonate injection alone and intralesional Meglumine Antimonate injection plus local barberry root extract on improvement of skin lesions of patients with cutaneous leishmaniasis 2013-03-21 anticipated 40 Complete https://irct.ir/trial/16256 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 2-3 cutaneous leishmaniasis. Intervention 1: Intervention Group: The cases received weekly intralesional Meglumine Antimonate injection plus 10% barberry root extract cream three times a day for 8 consecutive weeks. Intervention 2: Control Group: The controls received weekly intralesional Meglumine Antimonate injection plus placebo for 8 consecutive weeks.
public Dr. Mehdi Razmara Farzaghi
Leishmaniasis Research Center, Ghaem Hospital, Koohsangi Ave.
Mashhad, Iran (Islamic Republic of) 00 RazmaraM941@mums.ac.ir Mashhad University of Medical Sciences scientific Dr Masoud Maleki
Imam Reza Hospital, Daneshgah Ave.,
Mashhad, Iran (Islamic Republic of) +98 51 3802 5723 MalekiM@mums.ac.ir Imam Reza Hospital Iran (Islamic Republic of) Inclusion criteria: Positive direct smear in terms of Leishman-Donovan body; time passed less than 6 months from legion onset; no other treatment received for leishmaniasis during the last three months; informed consent for participation; lesion located is in upper limbs or the face. Exclusion criteria: Allergy to Meglumine (severe local reactions or anaphylaxis) or topical compounds used; irregular visits; incidence of secondary infection of the lesions based on clinical features and the therapist’s judgment ; presence of systemic treatment indications for cutaneous leishmaniosis including lesions on joints, number of lesions more than or equal to 5, lesion size more than or equal to 5 cm. no limit no limit Both B55.1 Cutaneous leishmaniasis Treatment - Drugs Treatment - Drugs Intervention Group: The cases received weekly intralesional Meglumine Antimonate injection plus 10% barberry root extract cream three times a day for 8 consecutive weeks. Control Group: The controls received weekly intralesional Meglumine Antimonate injection plus placebo for 8 consecutive weeks. Enduration. Timepoint: On the last injection and 6 weeks later. Method of measurement: ruler. Vice-chancellery for Research of Mashhad University of Medicla Sciences Approved 2012-10-13 Ethics Committee of Mashhad University of Medical Sciences Vice-chancellery for Reasearch, Mashhad University of Medical Sciences, Daneshgah Ave., Mashhad Iran (Islamic Republic of)