Investigating the effect of honey on the treatment of patients with bedsores grade 1 and 2

Investigating the synergistic effect of honey on the healing of grade 1 and 2 bedsores in patients admitted to Ghaem Hospital in Mashhad

Clinical trial with a control group, with parallel groups, single-blind, randomized, phase 2 on 40 patients. www.random.org was used for randomization.

In this clinical trial study, 40 patients with grade 1 and 2 bedsores are selected, who are hospitalized in Ghaem Hospital of Mashhad, and the wound area of ​​these patients is taken on day 0. In 20 of these patients, unsterilized honey is used for dressing [9]. In addition, the presence of inflammatory factors such as CRP is also measured in the blood of these people, and the recovery process is checked and compared by means of a questionnaire. Number of blinds: one blind Blinding (subjects under study)

Inclusion criteria: People who have been confirmed with grade 1 and 2 bedsores and are hospitalized Criteria for not entering the study: People's lack of consent to participate in this study Age less than 18 years Allergy to honey Kidney failure patients Patients taking corticosteroids

intervention group: In this group, unsterilized honey will be used. The intervention method is as follows: - Dressing: For each patient, 25 ml of unsterilized honey is placed on a dressing measuring 10 x 10 cm. - control group: In this group, in order to compare with the intervention group and to investigate the effects of honey, ordinary dressing will be used. The control method is as follows:

1. Characteristics of bedsores - Assessment and healing process of bedsores based on the PUSH (Pressure Ulcer Scale for Healing) checklist 2. Laboratory parameters - CBC diff - SGOT - SGPT - BUN - Cr - CRP - Alb - Total protein

Randomization method: To ensure a fair distribution of patients between control and treatment groups, we will use the stratified randomization method. In this method, patients are first classified into four groups based on age: 18-40 years, 40-60 years, 60-80 years, and over 80 years. Randomization Unit: The unit of randomization is individual (individual randomization), which means that each patient is individually assigned to one of the control or treatment groups. Randomization layers: Patients are classified into four age strata to ensure that the age distribution in both groups is balanced: 8-40 years, 40-60 years, 60-80 years, and over 80 years. Randomization Tool: [random.org] (https://www.random.org/) site is used to generate the random sequence. This site generates random numbers that will be used to assign patients to groups. How to make a random sequence First, patients are divided into four age groups based on age: the number of patients in each age group is determined to maintain the balance between age groups in both control and treatment groups. To determine the group of each patient (control or treatment), random.org is used. This site generates random numbers. The generated random numbers are assigned to the patients in order. For each random number, it is determined whether the patient will be assigned to the control or treatment group. This is done completely randomly to ensure a fair distribution of patients between the groups.

allocation concealment: To conceal allocation and avoid bias, a blind method will be used: - Patients: Patients will not be informed of their group allocation (control or treatment) to reduce the effect of psychological bias. - The researcher analyzing the data: the researcher who analyzes the data will not be aware of the allocation of groups. This is done by coding the data in such a way that the identity of the groups is not known. This method ensures that the effect of bias in the randomization process and data analysis is minimized.

1. Preservation of the privacy of the participants: In order to preserve the privacy of the participants in the study, it is necessary not to publish their personal data. 2. Data security: As a fundamental principle, it is vital to protect the sensitive data of participants from unauthorized access and misuse. 3. Compliance with legal agreements: Research studies may have agreements with participants that prohibit the publication of individual data, and we must adhere to these agreements.