-
Study aim
-
Formulation and standardization of Yazd Meybod ethno-topical preparation made from cotton (Gossypium herbaceum L.) to evaluate the effect on cutaneous Leishmaniasis, a randomized, double blind, placebo controlled trial.
-
Design
-
This study is a single centered, double-blinded, placebo-controlled, randomized clinical trial which is a medical study involving human participants in which neither side knows who's getting the true remedy or placebo that subjects are randomly assigned to by random number table. There are two groups contaminated with cutaneous leishmaniasis that are matched by age and sex.
-
Settings and conduct
-
Patients are randomly divided into two groups by a random number table and receive a topical or placebo drug, which will be delivered according to the size of the skin lesion for the duration of the treatment and then to evaluate the healing of their wounds. Periodically, they refer to Nikopour Clinic in Yazd, which is under the supervision of Shahid Sadoughi University of Medical Sciences.
-
Participants/Inclusion and exclusion criteria
-
Inclusion criteria:
1-Cannot be using any kind of therapy for leishmaniasis
2-Have no kind of immune deficiency diseases
3-No lesions with a diameter bigger than 3 centimeters
4-No lesions located on the face or joints and have less than 5 lesions
5- Patients with less than 5 ulcers
Exclusion criteria:
1-Any severe side effects or allergies
2-Patients that do not apply the remedy daily or perform the protocol correctly
-
Intervention groups
-
In this study, two groups randomly receive topical medication or placebo. Each patient receives one milliliter of medication per square centimeter of lesion for 30 days and should visit on days 5, 10, 20 and 30 and their wounds should be evaluated.
-
Main outcome variables
-
The factors reported are sex, age, site, lesion duration, erythema size, induration, ulcer presence and laboratorial smear test result.