Investigating the effect of aloe vera capsules on the rash of hemodialysis patients in Arak

Investigating the effect of aloe vera capsules on the rash of hemodialysis patients in Arak

The present clinical trial study has a control group, with parallel groups, double-blind, randomized (using block randomization), phase 3 on 66 patients.

In this double-blind randomized clinical trial, hemodialysis patients suffering from pruritus referred to the dialysis department of Amir al-Momenin Hospital in Arak were divided into two identical intervention and control groups by means of block randomization. In the intervention group, patients received aloe vera capsules and in the control group, placebo capsules. In this study, the patients were blinded due to the identical appearance of the capsules, and the researcher was blinded due to not knowing the type of drug. Finally, two groups are compared in terms of itching intensity.

Conditions for inclusion in the study: Informed consent to enter the study; Age more than 18 years; There is no other reason for itching such as liver disease or allergy or skin disease; Ensuring the accuracy of dialysis patients; Patients diagnosed with chronic renal failure; Equal number of dialysis sessions per week. Conditions for not entering the study: History of itchy skin diseases; Taking pruritus drugs; Pregnancy or liver disorders; Hemodialysis for less than 6 months

Intervention group: In addition to routine medications, the patient is given an aloe vera capsule containing 100 mg of aloe vera product every 12 hours in the first week and three times a week from the second week (after each hemodialysis). Control group: In addition to routine medications, the patient is given placebo capsules similar to aloe vera capsules containing starch according to the medication schedule of the intervention group.

intensity of pruritus

The participants will be assigned to two intervention and control groups based on the randomization sequence that will be generated in advance. This sequence is unpredictable and its arrangement is completely random. Block randomization method with 8 blocks will be used to allocate the samples. In this way, using the site www.sealedenvelope.com, blocks of 8 letters A and B are randomly generated based on the sample size. The order of placement of letters A and B in each block from the first block to the last block is considered as a randomization sequence. The production of these blocks and their random sequence is completely done by this site and the researcher does not know how they are sequenced.

This study is of double-blind type. Blinding of the participants will be done using the same appearance of aloe vera capsules and placebo. Therefore, patients do not have any information about which group they will be assigned to. The blinding of the researcher is also done in this way that one person gives the drug to the patient, who has no knowledge of its type, and he himself completes the VAS scale for the patient.

After conducting this study and analytical studies on it, only a part of the data such as information about the main outcome and patient demographic information will be published to the researchers who do the necessary correspondence with the person in charge of this study.

Access will be from 2023/4/20 to 2026/4/20 for 3 years.

University researchers

Academic researchers or university professors or students who intend to use the data of this study, after obtaining permission from the relevant people mentioned, can use the information of this study in the field of metallurgical studies or other relevant review studies. In addition, if requested, they can use the information of this study for the prerequisites of their future studies and the existence of questions and ambiguities. Using the information of this study is subject to mentioning the names and logos of the responsible persons in this study.

Academic researchers and university professors, after contacting the respective professor by message or email, can request the utilization and use of data from Dr. Naser Saeedi and then Dr. Mustafa Taheri, respectively. Dr. Naser Saeedi: Phone: 09108072952; Email: nassersaidi@yahoo.com; Address: Amir Al Mo'minin Hospital, Basij Square, Sardasht, Arak. Dr. Mustafa Taheri: Phone: 09051036297; Email: dr.taheri110@gmail.com; Address: Research Assistant, Arak University of Medical Sciences, Basij Square, Sardasht, Arak, Iran.

Letter writing should be done with professors and universities.