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IRCT20230821059210N1 IRCT 2023-09-24 Jahrom University of Medical Sciences The effectiveness of leech therapy on the healing period of psoriasis Comparing the effect of leech therapy on the severity and extent of psoriasis lesions compared to conventional medical treatments in psoriasis patients 2023-09-23 anticipated 60 Complete https://irct.ir/trial/72501 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After going to the departments of both hospitals and getting the list of patients from them, the patients will be contacted and interested people will be registered. Then, from the obtained list, 60 people will be randomly selected into the random number table, and with the help of the Random Number Generator software, out of 60 people (numbers 1-60), 30 people will be randomly assigned to the intervention group, Blinding description: 1- The statistical expert will be unaware of the intervention and control group. He will not be told whether the data is from the intervention or control group. Rather, only the groups will be marked with numbers 1 and 2 or with A-B, so only the researcher knows and he can interpret the results. 2- The nurses providing routine care and the person collecting data at the end of the study will also be blinded. That is, they will not know which patient was in the intervention group and which patient was in the control group. Patients are given codes and only the researcher knows these codes. N/A psoriasis. Intervention 1: Intervention group: The amount of PASI will be checked before the start of the study. Then, for 5 weeks, with a time interval of 7 days, it will be done by placing 10 leeches in the affected area. Before using the leech, the leech will be kept in non-chlorinated water for 24 hours, and before sticking the leech, the target area will be washed with water and odorless soap. Then, wearing gloves, the leech will be removed. In order to prevent the irritation and irritation of the leech. At first, 10 leeches are placed in the infected areas and the leech treated area is observed and examined for 2 minutes (to check that the leech sticks and sucks blood). If the leech is able to stick and no blood sucking, with a needle, a small incision will be made in the area and the leech will be placed on that area. Then a wet gauze or a transparent plastic cup will be placed on it to provide moisture to the leech's body and prevent the leech from moving. During the leech treatment, the patient will be checked for bleeding, sensitivity, removal of the leech, movement and vital signs of the patient. After sucking the blood by the leech, the leech will either be removed by itself or it can be removed by pouring a few drops of alcohol or betadine. and in order to prevent the possible transmission of infection by leech, it should be destroyed by pouring alcohol. After each leech treatment session, the patient will be checked for the amount of bleeding and stabilization of vital signs, and if there is no problem, he will be discharged. Before the start of the study and after the end of leprosy therapy, the PASI level of the patients in both groups will be checked. It is worth noting that the patients will receive common psoriasis treatments during the study. Intervention 2: Control group: They receive common and standard psoriasis treatments, and before and after the intervention in the intervention group, a checklist to determine the severity and extent of psoriasis is completed for them. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: The access period starts 6 months after the results are published To whom: It will be available only to researchers working in academic and scientific institutions Conditions: Send the request to the responsible author's email, and if necessary, the information will be available for meta-analysis Where to obtain: 09177924361 Mohsen fasele How to obtain: Send the request to the responsible author's email, and if necessary, the information will be available for meta-analysis Comments:
public Mohsen fasele
Jahrom Motahari Street. University campus site. nursing school
jahrom Iran (Islamic Republic of) 7414846199 0098 71 5433001 m.fasele@jums.ac.ir Jahrom University of Medical Sciences scientific Mohsen fasele
Jahrom Motahari Street. University campus site. nursing school
Jahrom Iran (Islamic Republic of) 7414846199 0098 71 5434001 m.fasele@jums.ac.ir Jahrom University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) age 20-60, Absence of other skin disorders Having symptoms of psoriasis Insensitivity to leech 20 years 20 years Both Failure to attend meetings regularly Failure to follow the treatment process Pregnancy and breastfeeding Not using vitamins K, E, C, herbal supplements such as garlic, ginger, ginkgo, ginseng compounds, aspirin, dipyridamole, clopidogrel, heparin, warfarin and non-steroidal anti-inflammatory drugs. psoriasis L40.0 Treatment - Other Treatment - Drugs Intervention group: The amount of PASI will be checked before the start of the study. Then, for 5 weeks, with a time interval of 7 days, it will be done by placing 10 leeches in the affected area. Before using the leech, the leech will be kept in non-chlorinated water for 24 hours, and before sticking the leech, the target area will be washed with water and odorless soap. Then, wearing gloves, the leech will be removed. In order to prevent the irritation and irritation of the leech. At first, 10 leeches are placed in the infected areas and the leech treated area is observed and examined for 2 minutes (to check that the leech sticks and sucks blood). If the leech is able to stick and no blood sucking, with a needle, a small incision will be made in the area and the leech will be placed on that area. Then a wet gauze or a transparent plastic cup will be placed on it to provide moisture to the leech's body and prevent the leech from moving. During the leech treatment, the patient will be checked for bleeding, sensitivity, removal of the leech, movement and vital signs of the patient. After sucking the blood by the leech, the leech will either be removed by itself or it can be removed by pouring a few drops of alcohol or betadine. and in order to prevent the possible transmission of infection by leech, it should be destroyed by pouring alcohol. After each leech treatment session, the patient will be checked for the amount of bleeding and stabilization of vital signs, and if there is no problem, he will be discharged. Before the start of the study and after the end of leprosy therapy, the PASI level of the patients in both groups will be checked. It is worth noting that the patients will receive common psoriasis treatments during the study. Control group: They receive common and standard psoriasis treatments, and before and after the intervention in the intervention group, a checklist to determine the severity and extent of psoriasis is completed for them. Severity and extent of psoriasis. Timepoint: Before and after the intervention in both intervention and control groups. Method of measurement: Before and after the intervention by the index of the extent and severity of psoriasis by a specific checklist Psoriasis Area Severity Index (PASI). Jahrom University of Medical Sciences Approved 2023-07-29 Ethics Committee of Jahrom University of Medical Sciences motahari street jahrom Fars Iran (Islamic Republic of)