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IRCT20191104045328N13 IRCT 2022-12-18 Arak University of Medical Sciences The effect of aloe vera capsules on itching in hemodialysis patients Investigating the effect of aloe vera capsules on the rash of hemodialysis patients in Arak 2022-12-22 anticipated 66 Complete https://irct.ir/trial/67203 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Pruritus. Intervention 1: Intervention group: In addition to routine medicines, the patient is given aloe vera capsules containing 100 mg of aloe vera product twice a day (at 8 am and 8 pm) in the first week. From the second week, this capsule is given three times a week (after each hemodialysis, 1-2 hours apart from hemodialysis). Intervention 2: Control group: In addition to routine drugs, the patient is given placebo capsules similar to aloe vera capsules containing starch twice a day (at 8 am and 8 pm) in the first week. From the second week, this capsule is given three times a week (after each hemodialysis, 1-2 hours apart from hemodialysis). Yes - There is a plan to make this available What will be shared: 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. When: Access will be from 2023/4/20 to 2026/4/20 for 3 years. To whom: University researchers Conditions: 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. Where to obtain: 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. How to obtain: Letter writing should be done with professors and universities. Comments:
public Dr. Naser Saidi
Amir Al Mo'minin Hospital, Basij Square, Sardasht, Arak
Arak Iran (Islamic Republic of) 3848176941 +98 86 3417 3601 nassersaidi@yahoo.com Arak University of Medical Sciences scientific Dr. Seyed Amir Hossein Latifi
Research Assistant, Arak University of Medical Sciences, Basij Square, Sardasht, Arak, Iran
Arak Iran (Islamic Republic of) 3848176941 +98 86 3417 3532 salehi58@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) 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 18 years no limit Both History of itchy skin diseases Taking pruritus drugs Pregnancy or liver disorders Hemodialysis for less than 6 months L29.8 Other pruritus Treatment - Drugs Treatment - Drugs Intervention group: In addition to routine medicines, the patient is given aloe vera capsules containing 100 mg of aloe vera product twice a day (at 8 am and 8 pm) in the first week. From the second week, this capsule is given three times a week (after each hemodialysis, 1-2 hours apart from hemodialysis). Control group: In addition to routine drugs, the patient is given placebo capsules similar to aloe vera capsules containing starch twice a day (at 8 am and 8 pm) in the first week. From the second week, this capsule is given three times a week (after each hemodialysis, 1-2 hours apart from hemodialysis). Intensity of pruritus. Timepoint: Before and after the intervention. Method of measurement: Visual analogue scale of pruritus intensity. Arak University of Medical Sciences Approved 2022-06-13 Ethics Committee of Arak University of Medical Sciences Research Assistant, Arak University of Medical Sciences, Basij Square, Sardasht, Arak, Iran Arak Markazi Iran (Islamic Republic of)