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IRCT20201213049703N1 IRCT 2021-02-10 Kermanshah University of Medical Sciences Effect of herbal ointment in treatment of ulcers diabetes Evaluation of efficacy of herbal ointment containing aqueous extract Scrophularia Straita Boiss, Honey , Sativa Nigella oil ,Mazo, Apple Vinegar in treatment of ulcers diabetes 2021-04-04 anticipated 70 Complete https://irct.ir/trial/52998 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization and assigning people to groups The random number function is used using Excel software as follows: First, in a column, the groups are entered as A, B and below. In the opposite column, random numbers are generated using the RAND command. In the next step, using the sort command, random numbers are generated from small to large or vice versa, which causes the order of the groups, A, B, to be changed. Using the new order, people are assigned to different groups, Blinding description: Herbal ointments and routine treatment ointments are designed to be the same in terms of color and odor so that they are not recognizable to the patient and the caregiver. And only the statistical analyst should be aware of the ointment used. 3 Ulcers diabetes. Intervention 1: The herbal ointment of the design containing thirsty plant extract, honey, black seed oil, mazo will be provided to the patients of the intervention group in the form of ready-to-use tubes without printing of the design. Contains thirst extract, apple cider vinegar and normal saline, washed and dried with sterile gauze. The herbal ointment is then applied to the wound with a watering can and fixed with a four-layer sterile dry gauze with anti-allergy adhesive. Changing the dressing and using the ointment should be done once a day for the necessary time. (Depending on the patient's condition until complete treatment). Intervention 2: Liam topical ointment (manufacturer of Mehr Miracle Researchers) containing chamomile extract, 8% cow's eye, 13% beeswax and 17% honey as a routine ointment of Imam Khomeini Hospital in Kermanshah in the form of ready-to-use tubes without printing. Patients in intervention group 2 will be included. The procedure will be performed by washing the wound and surrounding tissues with normal saline solution and drying them with sterile gauze. Liam ointment is then applied to the wound with a watering can and fixed with a four-layer sterile dry gauze with anti-allergy adhesive. Changing the dressing and using the ointment should be done once a day for the necessary time. (Depending on the patient's condition until complete treatment). Yes - There is a plan to make this available What will be shared: Results can be shared after not identifying people. When: Access period starts 6 months after the results are published To whom: All interested people Conditions: For the use of other researchers Where to obtain: Toraj Ahmadi Jouybari dr.ahmadi_jouybari@yahoo.com How to obtain: 1. Send request to email 2. The purpose of the data request should be clear. 3. If approved by the main executor, action will be taken immediately Comments:
public Toraj Ahmadi Jouybari
Kermanshah - Naghlieh Ave - Imam Khomeini Hospital, Kermanshah
Kermanshah Iran (Islamic Republic of) 6718743161 +98 83 3727 2049 dr.ahmadi_jourbari@yahoo.com Kermanshah University of Medical Sciences scientific Toraj Ahmadi Jouybari
Kermanshah - Imam Khomeini Hospital, Kermanshah
Kermanshah Iran (Islamic Republic of) 6718743161 +98 83 3727 2049 dr.ahmadi_jourbari@yahoo.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients with diabetic ulcers no limit no limit Both Pregnant women Patients suffering from liver and kidney failure Childern People undergoing chemotherapy People receiving corticosteroids. E11.4 Type 2 diabetes mellitus with neurological complications Treatment - Other Treatment - Drugs The herbal ointment of the design containing thirsty plant extract, honey, black seed oil, mazo will be provided to the patients of the intervention group in the form of ready-to-use tubes without printing of the design. Contains thirst extract, apple cider vinegar and normal saline, washed and dried with sterile gauze. The herbal ointment is then applied to the wound with a watering can and fixed with a four-layer sterile dry gauze with anti-allergy adhesive. Changing the dressing and using the ointment should be done once a day for the necessary time. (Depending on the patient's condition until complete treatment) Liam topical ointment (manufacturer of Mehr Miracle Researchers) containing chamomile extract, 8% cow's eye, 13% beeswax and 17% honey as a routine ointment of Imam Khomeini Hospital in Kermanshah in the form of ready-to-use tubes without printing. Patients in intervention group 2 will be included. The procedure will be performed by washing the wound and surrounding tissues with normal saline solution and drying them with sterile gauze. Liam ointment is then applied to the wound with a watering can and fixed with a four-layer sterile dry gauze with anti-allergy adhesive. Changing the dressing and using the ointment should be done once a day for the necessary time. (Depending on the patient's condition until complete treatment) PUSH Score. Timepoint: Every week until the 12th week. Method of measurement: Based on the characteristics of diabetic ulcers. Wound area. Timepoint: Every week until the 12th week. Method of measurement: With a caliper, the dimensions of the wound, including the length and width of the wound, are measured and its area is calculated. Wound depth. Timepoint: Every week until the 12th week. Method of measurement: Wound depth is measured with forceps and calipers. Kermanshah University of Medical Sciences Approved 2020-04-11 Ethics committee of Kermanshah University of Medical Sciences Kermanshah, Shahid Beheshti Blvd., Kermanshah University of Medical Sciences Kermanshah Kermanshah Iran (Islamic Republic of)