Effectiveness of traditional medicine products Juniperus excelsa M.Bieb in the treatment of cutaneous leishmaniasis

Phase 3

Conditions: cutaneous leishmaniasis.
Cutaneous leishmaniasis

Registration Number: IRCT2015082523753N1

Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.