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IRCT20230131057295N1 IRCT 2023-02-27 Neyshabour University of Medical Sciences The effect of aerobic exercise concurrent with propolis supplementation in hemodialysis patients The effect of eight weeks of aerobic exercise with Propolis supplementation on some inflammatory and immune markers in hemodialysis patients 2023-04-04 anticipated 84 Complete https://irct.ir/trial/68366 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Among the people with kidney failure undergoing hemodialysis referred to 22 Bahman Neishabur Hospital, 84 patients will be included in this study based on the inclusion criteria and will be classified according to age and gender in a block manner, the participants will be randomly assigned to one of two intervention and control groups will be included, Blinding description: Capsules in all groups have been standardized in terms of appearance, color and smell. As each person enters the study based on the randomly generated sequence, the medication package in which the desired code is recorded will be assigned to the person, and therefore, before choosing the person, no one will be aware of the type of treatment he will receive. Finally, the data and information are given to the statistician with a special code for each group so that the statistician is also blinded. 3 Patients with complete renal failure undergoing hemodialysis. Intervention 1: Intervention group: 500 mg of propolis extract daily (two 250 mg propolis capsules, one after lunch and one after dinner) and walking 3 days a week with an exercise program according to the protocol for eight weeks. Capsules containing alki extract Propolis is prepared by Asal Shohdina Ya Golha company with registration number P0032. Intervention 2: Control group: The second group will take 500 mg of the same placebo daily (two capsules of 250 mg of placebo, one after lunch and one after dinner) and walk 3 days a week with an exercise program according to the protocol for eight weeks. Yes - There is a plan to make this available What will be shared: The anonymous information of the participants in this study will be shared if an official request is submitted to the university and approved by the research council of the relevant university. Also, the results of this study will be published in relevant articles. When: There is no specific time limit. To whom: Only researchers who formally request through the university research council will be granted access if the council approves. Conditions: In order to pool the results of several studies, data will be shared. Where to obtain: Vice President of Research and Technology of Neyshabur University of Medical Sciences How to obtain: The request should be sent in the form of an official proposal to the Research and Technology Vice-Chancellor of Neyshabur University of Medical Sciences and followed up through the council of this university. Comments:
public Iman Rahnama
Torghabeh city, Binaloud Higher Education Institute
Mashhad Iran (Islamic Republic of) 00000000000000 +98 51 3423 0564 imanrahnama5190@gmail.com Binaloud institute of higher education scientific Seyyed Mostafa Arabi
Baghcheban town, medical sciences campus, Neyshabur University of Medical Sciences
Neyshabur Iran (Islamic Republic of) 9318614139 +98 51 4333 3964 mostafa.arabi.nu@gmail.com Neyshabour University of Medical Sciences Iran (Islamic Republic of) An age range of 30 to 65 years ESRD patients on hemodialysis treatment Perform hemodialysis 3 days a week Willingness to participate in research Absence of any allergy to honey and its derivatives Ability to perform aerobic exercise 30 years 65 years Both BMI above 30 Acute heart attack in the last six months Any allergy to honey and its compounds Taking any medicine outside the routine treatment protocol of hemodialysis patients Smoking, drug addiction or alcohol consumption Having any acute illness or cancer, autoimmune diseases N18.5 Chronic kidney disease, stage 5 Treatment - Drugs Placebo Intervention group: 500 mg of propolis extract daily (two 250 mg propolis capsules, one after lunch and one after dinner) and walking 3 days a week with an exercise program according to the protocol for eight weeks. Capsules containing alki extract Propolis is prepared by Asal Shohdina Ya Golha company with registration number P0032. Control group: The second group will take 500 mg of the same placebo daily (two capsules of 250 mg of placebo, one after lunch and one after dinner) and walk 3 days a week with an exercise program according to the protocol for eight weeks. CRP. Timepoint: At the beginning and end of the study. Method of measurement: ELISA. Albumin. Timepoint: At the beginning and end of the study. Method of measurement: BROMOCRESOL GREEN. CRP to albumin ratio. Timepoint: At the beginning and end of the study. Method of measurement: It will be obtained by dividing the serum levels of C-reactive protein by albumin. The ratio of neutrophils to lymphocytes. Timepoint: At the beginning and end of the study. Method of measurement: After measuring neutrophils and lymphocytes with a cell counter, these items will be divided and the ratio will be obtained. The ratio of lymphocytes to platelets. Timepoint: At the beginning and end of the study. Method of measurement: After measuring lymphocytes and platelets with a cell counter, these items will be divided and the ratio will be obtained. Total antioxidant capacity. Timepoint: At the beginning and end of the study. Method of measurement: By colorimetric method. Neyshabour University of Medical Sciences Approved 2023-01-04 Neyshabur University of Medical Sciences Baghcheban town, Neishabur University of Medical Sciences, Medical Sciences Pardis Neyshabur Razavi Khorasan Iran (Islamic Republic of)