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IRCT20211211053349N1 IRCT 2022-03-25 Kerman University of Medical Sciences Evaluation of leishmaniasis wound healing in topical treatment with 5% thyme gel versus intra lesional(IL) Glucantime treatment 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 2021-12-25 anticipated 80 Complete https://irct.ir/trial/60555 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Health service research, Other design features: Type of double-blind randomized clinical trial studyRandomized, double-blind, placebo controlled clinical trial, Randomization description: 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, Blinding description: 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. 3 lesion of cutaneous Leishmaniasis. Intervention 1: Intervention group: Topical thyme gel treatment 0.5 gram for 2 times a day with topical injection of Glucantime once a week for 8 weeks until complete wound healing. Intervention 2: Control group: Topical injection of Glucantime every week for 8 weeks with placebo (gel base) 2 times a day. Yes - There is a plan to make this available What will be shared: Some of the patient data recorded in the questionnaire can be shared. When: Access starts from March 1401 To whom: Researchers and physicians working in private and public research and treatment centers Conditions: 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. Where to obtain: 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 How to obtain: 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. Comments: After justifying the goals of the project and before any treatment, consent is obtained from the patient
public Leila shirani Bidabadi
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5053 lshiranibidabadi@gmail.com Kerman University of Medical Sciences scientific leila shirani
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5829 lshiranibidabadi@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients must be 5 years old or older. The patient can be of both sexes. The number of wounds should not be more than 5. No sores on the face or ears. Affirmation of parasitic infection is required The patient has cutaneous leishmaniasis. The onset of their disease is less than 4 months 5 years no limit Both Pregnant women are excluded from the study. Patients with severe hypoglycemia are excluded from the study. Breastfeeding women are excluded from the study. Patients who have been treated with other methods (systemic Glucantime, combination therapy, etc.) patients who have been treated in other clinical trial B55.1 Cutaneous leishmaniasis Treatment - Drugs Placebo Intervention group: Topical thyme gel treatment 0.5 gram for 2 times a day with topical injection of Glucantime once a week for 8 weeks until complete wound healing. Control group: Topical injection of Glucantime every week for 8 weeks with placebo (gel base) 2 times a day. Wound healing. Timepoint: lesion diameter. Method of measurement: recurence. Kerman University of Medical Sciences Approved 2021-12-06 Ethics committee of Kerman University of Medical Sciences Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran Kerman Kerman Iran (Islamic Republic of)