Evaluation of the effectiveness of topical gel treatment containing standardized 5% hydroalcoholic extract of Zataria multiflora in comparison with intra lesional(IL) glucantime in the treatment of cutaneous leishmaniasis in human

effectiveness of gel 5% of Zataria multiflora with topical Glucantime.

1- Treatment with topical thyme gel 0.5 g for 2 times a day with topical injection of Glucantime once a week for 8 weeks until complete wound healing. Topical injection of Glucantime every week for 8 weeks with placebo (gel base) twice a day. Type of study is Randomized, double-blind, placebo controlled clinical trial. several patients are determined by patch test (80). (Randomized Allocation) are assigned to one of two treatment groups. In the research center, 40 patient lesions are treated topically with Glucantime injection with placebo gel and 40 patient lesions are treated topically with 5% thyme gel and topical Glucantime injection. Clinical trial is 3 phase.

40 patient lesions are treated with glucantime with placebo gel and 40 patient lesions are treated topically with 5% thyme gel and topical injection of glucantime. This is a double-blind study. The patient and the treating physician are not aware of the type of treatment. The topical gels are coded by the pharmacist and then the drug codes are returned after the results are known. Thyme gel and placebo gel are made by a pharmaceutical company.

Inclusion criteria: Patients with cutaneous leishmaniasis.5 years old or older. both sexes. wounds should not be more than 5.There should be no sores on the face or ears. positive smear test. exclusion criteria : Patients have not been treated. Pregnant and lactating women. severely susceptible to Glucantime

1- Treatment with topical thyme gel at the rate of 0.5 g at a rate of 2 times a day with topical injection of Glucantime once a week for 8 weeks Topical injection of Glucantime every week for 8 weeks with placebo (gel base) twice a day.

healing ,lesion diameter, Recurrence

80 lesions of patients with rural cutaneous leishmaniasis (leishmaniasis) participating in the study are randomly assigned to one of two treatment groups. In this study, block randomization method is used, for which block is used. Fours are used. Regarding the details of how to do randomization, in block randomization the size of all blocks is equal. Within each block of 4, 2 people are randomly assigned to group A and 2 people are randomly assigned to group B. 20 blocks of 4 are used for this study. Be. Block randomization is to ensure that exactly the same number of participants enter the intervention and control group at consecutive but equal intervals. The size of each block is 4 people. In this way, for example, one type of treatment is given to the first block, another type to the second, and again the first type to the third block, and so on. The advantage of block randomization is that the balance of the number of participants in each group is guaranteed. The difference in the number of people in each group will never be more than half the number of people in each block. Performing design of blocked randomization experiments with R software, which is one of the best statistical software. This software uses Package Blockrand. This package creates a random block for clinical trials and helps create randomization cards that the study coordinator can use to assign new people to his or her treatment. Random Block Quadruple All possible blocks are arranged as follows Block 1: ABAB block 2: AABB block: 3: ABBA block 4: BBAA block 5: BABA Block 6: BAAB We need 20 blocks to select 80 people. We randomly select these blocks from 1 to 6. Using software R, we choose a random number between the numbers 1 to 6. For example, if the number 6 Selected as the first block and number 2 as the second block, BAABAABB will be given to the participants in the study, respectively. Finally, group A will receive control intervention and group B will receive treatment intervention. The blockrand function is used to create a data frame with sequential block treatment randomizations. When performing a categorized study, you must run blockrand once for each layer, then optionally combine different data frames with rbind. Save the data frame (s), and when the study is complete, the data can be added to the data frame for analysis. The plotblockrand function is used to create randomization cards to be used when assigning people to treatment. The cards are printed and sealed in envelopes, then when a new subject is registered, the next envelope is opened and the subject is assigned to the relevant treatment. This function generates random allocation for clinical trials. Randomization is done in blocks to balance the treatments.

This is a double-blind study. The patient and the treating physician are not aware of the type of treatment. The topical gels are coded by the pharmacist and then the drug codes are returned after the results are known. Thyme gel and placebo gel are made by a pharmaceutical company.

Some of the patient data recorded in the questionnaire can be shared.

Access starts from March 1401

Researchers and physicians working in private and public research and treatment centers

Doctors, specialists and researchers who treat leishmaniasis patients in medical and research centers are allowed to send requests for unidentifiable personal data or other documents. No analysis is allowed on the delivered data.

Dr leila Shirani Bidabadi Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran Postal Code: 7616913555 Phone : 009834 31325829 Fax : 009834 31325830 Mobile :09132196482

Due to the fact that patients with leishmaniasis ulcers come in the period of autumn and winter. Until the fall of 1402, these documents are available.

After justifying the goals of the project and before any treatment, consent is obtained from the patient