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IRCT20220102053595N1 IRCT 2022-02-17 Islamic Azad University The effect of propolis supplementation in hemodialysis patients The effect of 8 weeks of aerobic exercise with propolis supplementation on biomarkers of oxidative stress in hemodialysis patients 2022-02-19 anticipated 60 Complete https://irct.ir/trial/61881 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Among the patients with renal failure undergoing hemodialysis referred to Ale Muhammad Medical polyclinic and Emergency service in Mashhad, 60 patients will be selected based on inclusion criteria and personal satisfaction and will be matched according to age and gender, then randomly assigned to one of four intervention and control groups. Patients will be randomly divided into intervention and control groups using statistical software and block randomization, Blinding description: The capsules are standardized in all groups in terms of appearance, color, and odor. From the selection of the person, no one will be aware of the type of treatment he/she will receive. Finally, data and information are given to the statistician with a special code for each group, so that the statistician can also be blinded. N/A End stage renal disease. Intervention 1: Intervention group: the first group received 500 mg of propolis per day, 2 capsules containing 250 mg Propolis extract, 1 capsule before lunch, and 1 capsule before dinner, with 3 days a week exercise program with a stationary bike according to the protocol for 8 weeks. Propolis capsules have been prepared by Shahdineh Golha Honey Company located in Najafabad, Isfahan, and propolis extract has been extracted alcoholically. Intervention 2: Intervention group: the second group received 500 mg of propolis per day, 2 capsules containing 250 mg Propolis extract, 1 capsule before lunch, and 1 capsule before dinner, without exercise for 8 weeks. Propolis capsules have been prepared by Shahdineh Golha Honey Company located in Najafabad, Isfahan, and propolis extract has been extracted alcoholically. Intervention 3: Control group: the third group received 500 mg of placebo per day, 2capsules containing 250 mg placebo, 1 capsule before lunch, and 1 capsule before dinner, with 3 days a week exercise program with stationary bike according to the protocol for 8 weeks. Intervention 4: Control group: the fourth group received 500 mg of placebo per day, 2 capsules containing 250 mg placebo extract, 1 capsule before lunch, and 1 capsule before dinner, without exercise for 8 weeks. Yes - There is a plan to make this available What will be shared: Individually nonidentifiable information of participants will be shared in this study. Also, the protocol, results and statistical analysis of the study will be published in the relevant articles. When: Unidentifiable personal information of the participants will be available after the publication of the related articles. To whom: Unidentifiable personal information of the participants will be made available to other researchers at academic institutions. Conditions: Unidentifiable personal information of participants can only be used for research Where to obtain: send an email: hamidipour.sina.nu@mshdiau.ac.ir How to obtain: Researchers in academic institutions can send their request by e-mail to the mentioned email. The data will be sent to them after consulting and approving the research team. Comments:
public Sina Hamidi pour
Ostad Yusofi Street, Emamieh Boulevard ,GhasemAbad, Mashhad, Iran.
Mashhad Iran (Islamic Republic of) 9187147578 +98 51 3661 3379 hamidipour.sina.nu@mshdiau.ac.ir Islamic Azad University scientific Zohre Amir khani
Ostad Yusofi Street, Emamieh Boulevard ,GhasemAbad, Mashhad, Iran.
Mashhad Iran (Islamic Republic of) 9187147578 +98 51 3661 3379 sahar56h@yahoo.com Islamic Azad University Iran (Islamic Republic of) An age range of 18 to 65 years ESRD patients on hemodialysis treatment Perform hemodialysis 3 days a week Absence of any physical abnormalities or bone diseases that interfere with their physical activity Willingness to participate in research 30 years 65 years Both BMI above 30 kg/m Disease (gallstones, cancer, and acute disease) Acute heart accident in the past year Taking any medicine outside the routine treatment protocol of hemodialysis patients Use of oral and injectable nutritional supplements except nephrovit and iron supplements according to the protocol Any allergy to honey and its compounds Leaving the patient with his/her personal consent Smoking, drug addiction or alcohol consumption N18.5 Chronic kidney disease, stage 5 Treatment - Drugs Treatment - Drugs Placebo Placebo Intervention group: the first group received 500 mg of propolis per day, 2 capsules containing 250 mg Propolis extract, 1 capsule before lunch, and 1 capsule before dinner, with 3 days a week exercise program with a stationary bike according to the protocol for 8 weeks. Propolis capsules have been prepared by Shahdineh Golha Honey Company located in Najafabad, Isfahan, and propolis extract has been extracted alcoholically. Intervention group: the second group received 500 mg of propolis per day, 2 capsules containing 250 mg Propolis extract, 1 capsule before lunch, and 1 capsule before dinner, without exercise for 8 weeks. Propolis capsules have been prepared by Shahdineh Golha Honey Company located in Najafabad, Isfahan, and propolis extract has been extracted alcoholically. Control group: the third group received 500 mg of placebo per day, 2capsules containing 250 mg placebo, 1 capsule before lunch, and 1 capsule before dinner, with 3 days a week exercise program with stationary bike according to the protocol for 8 weeks Control group: the fourth group received 500 mg of placebo per day, 2 capsules containing 250 mg placebo extract, 1 capsule before lunch, and 1 capsule before dinner, without exercise for 8 weeks Malondialdehyde. Timepoint: At the beginning and end of the study. Method of measurement: kit. Total antioxidant capacity. Timepoint: At the beginning and end of the study. Method of measurement: kit. Systolic blood pressure. Timepoint: At the beginning and end of the study. Method of measurement: Mercury manometers. Diastolic blood pressure. Timepoint: At the beginning and end of the study. Method of measurement: Mercury manometers. Nutritional status. Timepoint: At the beginning and end of the study. Method of measurement: Food recall and 3-day food record questionnaires. Anthropometric indicators. Timepoint: At the beginning and end of the study. Method of measurement: Weighing scale, Tape measure, BIA. Personal financial source Approved 2022-01-19 Research Ethics Committees of Islamic Azad University- Mashhad Branch Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)