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IRCT2015082523753N1 IRCT 2015-09-05 Shiraz University of Medical Sciences Effectiveness of traditional medicine products Juniperus excelsa M.Bieb in the treatment of cutaneous leishmaniasis Determination of the efficacy of cryotherapy plus topical Juniperus excelsa M.Bieb, based on traditional Persian medicine, versus cryotherapy alone in the treatment of cutaneous leishmaniasis: a double-blind randomized clinical trial 2015-10-07 anticipated 60 Complete https://irct.ir/trial/20244 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: invivo and invitro phase of the study has been completed and now this study is carried out the effects of drugs on humans, , Randomization description: Random allocation software Ink was used to create a randomization table, Blinding description: In order to blind the investigator, medications are named A (Juniperus excelsa) and B (Placebo). The patient are not considered the type of drug are assigned to. The groups are also coded A and B for statistical analyzes. 3 cutaneous leishmaniasis. Intervention 1: Intervention group: cryotherapy as a standard treatment in addition to cream (topical pharmaceutical products) containing 5% extract of Juniperus excelsa M.Bieb adminnistrate, three times daily for 12 weeks. Intervention 2: control group: cryotherapy as a standard treatment in addition to topical placebo cream with drug-like compounds and color with the exception of Juniperus excelsa M.Bieb extract, administrate every 8 hours daily for 12 weeks. http://journals.plos.org/plosntds/article?id=10.1371/journal.pntd.0005957http://journals.plos.org/plosntds/article?id=10.1371/journal.pntd.0005957 Introduction: Cutaneous leishmaniasis is one of the highly prevalent endemic diseases in the Middle East and North Africa. Many treatment modalities have been recommended for this condition but success rates remain limited. Herbal remedies have also been used for treatment but evidence-based clinical trials with these products are sparse. In-vitro and in-vivo studies have shown the anti-leishmanial and curative effects of extract of fruits and leaves of Juniperus excelsa (J. excelsa). The aim of this study was to determine the efficacy of topical J. excelsa M. Bieb extract as an adjuvant to cryotherapy for the treatment of human CL. Materials and Methods: This study was designed as a two-arm triple-blind randomized placebo-controlled clinical trial using a parallel design. Seventy-two patients with clinical diagnosis of CL confirmed by leishmania smears were allocated to receive either a topical formulation of leaf of J. excelsa extract (group A) or placebo (group B) for 3 months. Both groups received cryotherapy as baseline standard treatment. Patients were evaluated before and weekly after the intervention was initiated until complete cure. Results: Overall, 82% of patients in group A, experienced complete cure and 9% of them had partial cure. On the other hand, 34% in group B reported complete cure, while 14% of them had partial cure at the end of treatment protocol with a significant difference between the two groups (p< 0.001). The mean duration to healing of the lesions in patients who received J. excelsa extract was statistically significantly shorter than the placebo group (p=0.04). No significant side effect was seen in the J. excelsa extract group except for mild to moderate local irritation after a few weeks in a few numbers of patients. Conclusion: The results of this study showed that topical J. excelsa extract can be used as an adjuvant treatment modality in addition to cryotherapy for accelerating the time to cure in addition to increasing the complete cure rate in CL. Key Words: cutaneous leishmaniasis, Juniperus excelsa, Traditional Persian Medicine, herbal medicine, cryotherapy. Yes - There is a plan to make this available What will be shared: The charasrristic of the patients participating in the study is reported in the published article. When: The documentation had been published on PLOS Neglected Tropical Diseases journal's website . To whom: All of the researchers Conditions: Provided that cite to the article if thedata and results of this study are used Where to obtain: PLOS Neglected Tropical Diseases journal's website How to obtain: visit the PLOS Neglected Tropical Diseases journal's website and also sending a request via the email to the researchers Comments:
public Dr. Mohammad Mahdi Parvizi
7th floor, building No.2, School of Medical Science, Zand blv, Shiraz, Fars, Iran
Shiraz Iran (Islamic Republic of) 7134845794 +98 71 3234 7966 mmparvizi@gmail.com Shiraz University of Medical Sciences scientific Dr. Farhad Handjani,
Dermatology department of Shahid Faghihi Hospital, Zand blv. Shiraz, Fars, Iran
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3231 9049 hanjanif@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Age 18 to 70 years the maximum The maximum duration of their involvement by leishmaniasis is 4 months Having physical health except the cutaneous leishmaniasis infection Having 4 or less of the lesion leishmaniasis lesions Did not taking any of topical and systemic anti-Leishmania treatment during last 4 weeks Cutaneous leishmaniasis is approved of by smear 18 years 70 years Both Patients with complex forms of leishmaniasis and symptoms of mucousal leishmaniasis Having more than 4 lesions The lesions greater than 5 cm Sub-cutaneous nodules Regional adenopaty if greater than 1 cm size Patients with immunodeficiency disease The infants and children less than 18 years Women in lactation and pregnancy Patients with satellite lesions or sporotrichoid lesions Patients with facial cutaneous leishmaniasis lesions B55.1 Cutaneous leishmaniasis Treatment - Drugs Placebo Intervention group: cryotherapy as a standard treatment in addition to cream (topical pharmaceutical products) containing 5% extract of Juniperus excelsa M.Bieb adminnistrate, three times daily for 12 weeks. control group: cryotherapy as a standard treatment in addition to topical placebo cream with drug-like compounds and color with the exception of Juniperus excelsa M.Bieb extract, administrate every 8 hours daily for 12 weeks. Size and area of leishmaniasis lesion. Timepoint: previous of the starting the treatment, weekly in the first month of treatment and every two weeks from second month to the end of the study. Method of measurement: Cooley and math with the square millimeters. Duration of the healing the lesion. Timepoint: At the end of the treatment proccess. Method of measurement: The time interval between the beginning and end of treatment in days. Shiraz University of Medical Sciences Approved 2015-08-23 Ethics committee of Shiraz University of Medical Sciences Shiraz University of Medical Sciences, Zand blv., Shiraz, Fars, Iran Shiraz Fars Iran (Islamic Republic of)