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IRCT20210905052377N1 IRCT 2021-12-15 Kerman University of Medical Sciences Evaluation of the effect of traditional indigo, pistachio gum and chia seeds on leishmaniasis skin wounds Evaluation of the effect of herbal product containing indigo (Indigofera argentea), pistachio gum (pistacia atlantica) and chia seed (Salvia hispanica) in patients with rural cutaneous leishmaniasis based on folk medicine of Sistan and Baluchestan province 2021-12-22 anticipated 60 Complete https://irct.ir/trial/58577 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done by assigning patients to two groups using the permutation random block method in 4 blocks.The random permutation block table for the two groups, based on which patients are assigned to the two groups, is prepared using the R software as follows. (A) is the control group and (B) is the intervention group. B A A A A B A A B B A A B B B B B A A B B A A A B B A B B A B B A A B B A B A B A A B A A B B A A A B B B B A B A A B A, Blinding description: Eligible and volunteer patients are randomly divided into two groups of 30 patients. Patients do not know which drug or placebo each member of the group is receiving. The treating physician, filing staff who measure and monitor the size of the wound, and nursing staff who inject glucantime injections topically and dress the wounds of both groups with medication and placebo are also unable to diagnose the drug and placebo. For standardization and blinding, herbal powder and placebo powder, which is the same color as the standard food coloring of the plant powder, are placed in identical one-gram capsules, and the cans for the capsules are marked similarly and marked with the abbreviations A and B. When consuming the powder, it is taken out of the capsule and with distilled water, it becomes a paste with a firm consistency and the patient's wound is bandaged. At the end, statistical information is given anonymously to the statistician to analyze the information. 3 Leishmaniasis. Intervention 1: Intervention group: Simultaneously with the use of the patient's main drug, the compounds of this study, including indigo, coriander gum and chia seeds, after preparation from reputable perfumers in Chabahar, are studied by botanists of the Faculty of Traditional Medicine and the Kerman School of Pharmacy to identify the genus and species. Plant registration in the herbarium of Kerman University of Medical Sciences has been performed by obtaining the herbarium number. Taking UV rays for disinfection is subject to microbial control tests. And after standardization, it is packaged. Due to the fact that the amount of oral consumption of Nile 2 derms is equal to 6.2 grams, coriander gum 2 mesqal is equal to 9 grams and Lesan al-Abal 3 derms is equal to 9.3 grams in traditional medicine texts and the consumption of chia seeds is up to 25 grams. Since the use of some drugs in traditional medicine as powder extracts, first the dough is placed in molds of the desired dimensions and then dried and stored, and when needed and used, the dough is put back on the stand with some water. In the common method of Balochistan region, some of the mixed powder with some water is made into a paste with medium consistency and is placed on the wound and then it is bandaged with a clean cloth. In this study, for standardization and blinding, it was planned that the powder in the amount of 1000 mg be placed in large capsules of 1 g and when used, it is combined with 0.6 cc of distilled water and made into a paste with medium consistency. The amount used for wound dressing is to create a layer the size of a wound with a thickness of three millimeters of the product. Therefore, first the content of each capsule is converted into a paste and then based on the dimensions of the lesion, all or some of it is used. This product is used twice a day for a month. Intervention 2: Control group: This group also receives the main drug similar to the intervention group. Placebo, which is prepared from food powder and matched with the ineffective standard food color of the product, is placed in capsules of the same color and weight. It is exactly the same as the intervention group. Yes - There is a plan to make this available What will be shared: Summary of all personal information that is examined and analyzed for the main, sub-purposes in the relevant tables that are necessary for the publication of articles in foreign and domestic scientific journals are provided. The application form is submitted through their related scientific institutions When: Six months after the article was published To whom: The data will be accessible to researchers upon request through the relevant science center, and industrialists upon request through the relevant authorities. Conditions: For use in scientific research with reference Where to obtain: Saeidali Bozorgzade S.bozorgzade@kmu.ac.ir How to obtain: After receiving the request and coordination with the supervisor and research assistant of Kerman University of Medical Sciences, the materials will be sent. Comments:
public Saeedali Bozorgzade
Faculty of persian Medicine, Kerman University of Medical Sciences, Haft Bagh Blvd.
Kerman Iran (Islamic Republic of) 7616913555 31326161 34 0098 S.bozorgzade@kmu.ac.ir Kerman University of Medical Sciences scientific Hossein Karegar Barzi
Faculty of Traditional Medicine, Kerman University of Medical Sciences, Haft Bagh Blvd.
Kerman Iran (Islamic Republic of) 7616913555 31326161 34 0098 karegar.h.b@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) Wet skin lesions Laboratory diagnosis of positive smear with Giemsa staining Positive PCR test Treated with topical - injectable glucantime Signing the informed consent of the person or his / her guardian 18 years 70 years Both Lack of physical diseases such as liver disease, cardiovascular problems and kidney problems No pregnancy and lactation No history of leishmaniasis in the past Lack of recurrences and failure of classical treatment No atypical wounds B55.1 Cutaneous leishmaniasis Treatment - Drugs Placebo Intervention group: Simultaneously with the use of the patient's main drug, the compounds of this study, including indigo, coriander gum and chia seeds, after preparation from reputable perfumers in Chabahar, are studied by botanists of the Faculty of Traditional Medicine and the Kerman School of Pharmacy to identify the genus and species. Plant registration in the herbarium of Kerman University of Medical Sciences has been performed by obtaining the herbarium number. Taking UV rays for disinfection is subject to microbial control tests. And after standardization, it is packaged. Due to the fact that the amount of oral consumption of Nile 2 derms is equal to 6.2 grams, coriander gum 2 mesqal is equal to 9 grams and Lesan al-Abal 3 derms is equal to 9.3 grams in traditional medicine texts and the consumption of chia seeds is up to 25 grams. Since the use of some drugs in traditional medicine as powder extracts, first the dough is placed in molds of the desired dimensions and then dried and stored, and when needed and used, the dough is put back on the stand with some water. In the common method of Balochistan region, some of the mixed powder with some water is made into a paste with medium consistency and is placed on the wound and then it is bandaged with a clean cloth. In this study, for standardization and blinding, it was planned that the powder in the amount of 1000 mg be placed in large capsules of 1 g and when used, it is combined with 0.6 cc of distilled water and made into a paste with medium consistency. The amount used for wound dressing is to create a layer the size of a wound with a thickness of three millimeters of the product. Therefore, first the content of each capsule is converted into a paste and then based on the dimensions of the lesion, all or some of it is used. This product is used twice a day for a month. Control group: This group also receives the main drug similar to the intervention group. Placebo, which is prepared from food powder and matched with the ineffective standard food color of the product, is placed in capsules of the same color and weight. It is exactly the same as the intervention group. Rural leishmaniasis skin lesion. Timepoint: Before the intervention and the days (7, 14, 21, 28) and one month after. Method of measurement: With a caliper, two cross diameters of the wound are measured in centimeters. The wound area in terms of square centimeters is calculated by a camera with software. Kerman University of Medical Sciences Approved 2021-11-08 Ethics Committee of Kerman University of Medical Sciences Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway Kerman Kerman Iran (Islamic Republic of)