The effect of 5% root extract of Arnebia euchroma Ointment on pressure sore

The effect of Arnebia euchroma ointment on accelerating bed sore healing

Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2-3 on 20 patients.

Patients are among those with pressure sores who are cared for in a nursing home or home or are selected from patients referred to medical centers. Participants, researchers and nurses are not aware of the type of ointment used and the final results are reported without knowing the type of drug used.

The statistical population of the present study includes patients with pressure sores and 20 patients with grade 1, 2 and 3 pressure sores will be included in the study. Patients with bed sores of grade 4, patients with wounds other than pressure sores such as infectious wounds, etc.,hypersensitivity to the Arnebia euchroma , patient dissatisfaction, diabetic patients, patients with wound healing disorders and patients who are unable to feed orally are excluded from the study.

Patients are divided into two groups: one group uses standard treatment (silver sulfadiazine ointment) and the other group uses ointment containing 5% root of Arnebia euchroma plant.

Since no systematic study has been done on the effects of this plant on bed sores; The aim of this study was to evaluate the effect of Abu Khalsa ointment on bed sores. We evaluate bed sores according to the amount of discharge, depth of the wound, diameter or area of the wound, and erythema.

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.

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.