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IRCT20170818035762N4 IRCT 2023-01-17 Mazandaran University of Medical Sciences The effect of Arnebia euchroma on pressure sore The effect of 5% root extract of Arnebia euchroma Ointment on pressure sore 2020-11-09 anticipated 20 Complete https://irct.ir/trial/53012 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization list is prepared by a person who is not present in the study. The randomization method will be based on the "balanced block randomization" method, in such a way that the number of people who will participate in the study, in the order of entering the study, will be divided into blocks whose size is determined by the person in question. This number will remain hidden so that the people present in the study are not aware of the size of the blocks. Allocation of each person in each block is done equally between two groups by generating random numbers in Excel software. For example, if the size of the block is 4, in the Excel software, 2 codes A and 2 codes B are written in 4 rows, and a random number is created in front of each one, and by sorting these 4 rows based on the generated random numbers, the codes A and B will be randomly assigned to the people of this special block. This is done for other blocks as well. Allocation of codes A and B to intervention and control will be done randomly by a third party and will be reopened after analyzing the data and summarizing the results. Based on the random allocation list, the third person writes numbers from one to n (sample size) on the uniform packages of ointments, and in this way, the participants in the study and the researchers will not be aware of the contents of the packages and the grouping of A and B. The random allocation list will be reopened after data collection is completed to determine the two study groups for statistical analysis, Blinding description: In this intervention, Arnebia euchroma ointment and silver sulfadiazine ointment are available, and the blinding procedure is such that the ointments containing Arnebia euchroma and silver sulfadiazine ointments are placed in the same package and coded by a third party, and then available to the training nurse. is seen The participants, the main researcher (who is also responsible for the care of the patients) and the data analyst will not know about the content of the ointments. 2-3 Pressure sore. Intervention 1: Intervention group:Hava Chubeh (Abu Khalsa) is a herbaceous plant, stable and covered with coarse fibers. The part used by this plant is its root, which contains various compounds such as alkanin and chiconin. Alkanin or oncosine is a pigment with the formula C16H16O5 with a molecular weight of 228.29. It is dissolved in aqueous solutions, chloroform, acetic acid and in various oils. Its right-handed form is called chiconin and its racemic form is called chicalkine.First, the wound site is washed with normal saline serum, then the wound is covered with a suitable amount of ointment that contains 5% of the root of Abu Khalsa plant (Hawoobeh) to a thickness of one millimeter so that the wound surface is completely covered. Then, by placing a prepared pad or gasoline on the wound, the position is bandaged. This process is continued once every 12 hours according to the amount of discharge until complete healing.Ointment is produced in 50 g tubes by Amir Giah Amir Company in Barij Essential Oil Company. Intervention 2: Control group: First, the wound site was washed with normal saline, then the wound was covered with a suitable amount of silver sulfadiazine ointment to a thickness of mm so that the wound surface was completely covered. Then, by placing a prepared pad or gauze on the wound, the position is bandaged. All steps are performed by a trained nurse. The dressing is opened after 12 hours and the mentioned steps are repeated. This process is continued once every 12 hours according to the amount of wound secretion until complete healing. The ointment is produced in 50 g tubes by Amir Giaat Company in Barij Essential Oil Company. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Dr.ArMarghan Kazeminejad
Headquarters of Mazandaran University of Medical Sciences. At the beginning of Valiasr Highway.Sari
Sari Iran (Islamic Republic of) 4815733971 +98 11 3304 4001 A.kazeminejad@mazums.ac.ir Mazandaran University of Medical Sciences scientific Dr.ArMarghan Kazeminejad
Headquarters of Mazandaran University of Medical Sciences. At the beginning of Valiasr Highway.Sari
Sari Iran (Islamic Republic of) 4815733971 +98 11 3304 4001 A.kazeminejad@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Patient with grade 1 and 2 and 3 pressure sore no limit no limit Both Patient with grade 4 pressure sore Patients with wounds other than pressure wounds such as infectious wounds and ... Hypersensitivity to Arnebia euchroma Patient dissatisfaction Diabetic patients Patients with wound healing disorders Patients who are unable to feed orally L89 Pressure ulcer Treatment - Drugs Placebo Intervention group:Hava Chubeh (Abu Khalsa) is a herbaceous plant, stable and covered with coarse fibers. The part used by this plant is its root, which contains various compounds such as alkanin and chiconin. Alkanin or oncosine is a pigment with the formula C16H16O5 with a molecular weight of 228.29. It is dissolved in aqueous solutions, chloroform, acetic acid and in various oils. Its right-handed form is called chiconin and its racemic form is called chicalkine.First, the wound site is washed with normal saline serum, then the wound is covered with a suitable amount of ointment that contains 5% of the root of Abu Khalsa plant (Hawoobeh) to a thickness of one millimeter so that the wound surface is completely covered. Then, by placing a prepared pad or gasoline on the wound, the position is bandaged. This process is continued once every 12 hours according to the amount of discharge until complete healing.Ointment is produced in 50 g tubes by Amir Giah Amir Company in Barij Essential Oil Company. Control group: First, the wound site was washed with normal saline, then the wound was covered with a suitable amount of silver sulfadiazine ointment to a thickness of mm so that the wound surface was completely covered. Then, by placing a prepared pad or gauze on the wound, the position is bandaged. All steps are performed by a trained nurse. The dressing is opened after 12 hours and the mentioned steps are repeated. This process is continued once every 12 hours according to the amount of wound secretion until complete healing. The ointment is produced in 50 g tubes by Amir Giaat Company in Barij Essential Oil Company. Changing the condition of the bed sore. Timepoint: Before the intervention and then every week until the lesion heals. Method of measurement: By viewing images taken from the affected area. Mazandaran University of Medical Sciences Approved 2021-01-24 Ethics committee of Mazandaran University of Medical Sciences Mazandaran University of Medical Sciences, at the beginning of Valiasr Highway, Joibar three ways, Imam Square, Sari, Mazandaran Province sari Mazandaran Iran (Islamic Republic of)