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IRCT20141208020249N4 IRCT 2018-12-05 Sanandaj University of Medical Sciences Intravenous Vitamin C Supplementation on the Quality of Sleep, Itching,Restlessleg Syndrome in Patients Undergoing Hemodialysis Effect of Intravenous Vitamin C Supplementation on the Quality of Sleep, Itching,Restlessleg Syndrome in Patients Undergoing Hemodialysis In Tohid Hospital in Sanandaj at 2016 2015-04-02 anticipated 90 Complete https://irct.ir/trial/34623 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Prior to the commencement of the study, the code of medication prepared pre-prepared by a pharmacist outside the study is placed in the envelope, and the patient chooses to choose one of the envelopes upon signing the consent after signing consent. The medication code will not be delivered to the executive team until the completion of the study, Blinding description: Drugs and placebo are packaged and coded by a pharmacist outside the study in similar containers and in similar sizes. The drug code is not provided to the researcher until the end of the study and the start of the analyzes. The patient researcher and clinical evaluator were also blinded of the contents of the drug containers. N/A Condition 1: Chronic kidney disease. Condition 2: restless leg syndrome. Condition 3: Sleep Quality. Intervention 1: Intervention group: People who need dialysis which referring to dialysis department of Sanandaj Tohid Medical CenterThe intervention group received a 5-cc (500 milligram) vial of vitamin C from the Daropakhsh company. Intervention 2: Control group: People who need dialysis which referring to dialysis department of Sanandaj Tohid Medical Center. In the control group, 5 cc normal saline was given as a placebo for injection three times a week at the end of each dialysis session and intravenously for eight weeks. Yes - There is a plan to make this available What will be shared: All data is from the proposal, raw data and project reports When: Data is available from the legal system six months after publication for two years To whom: All persons will be able to access the Kurdistan University of Medical Sciences's request to the Kurdistan University of Medical Sciences. Conditions: For legal issues and the need to use data in future studies Where to obtain: Shahdak Dadashpour - Tohid Hospital - Kurdistan University of Medical Science How to obtain: After submitting a request to the Kurdistan Research and Technology Dept. of Science and Technology, a call for submission is given. Comments:
public Minoo sadat Hajmiri
Kurdistan University of Medical Science
Sanandaj Iran (Islamic Republic of) 6617713446 008733664645 ehaj@yahoo.com Sanandaj University of Medical Sciences scientific Shadak Dadashpour
Kurdistan University of Medical Science
Sannadj Iran (Islamic Republic of) 6617713446 +98 87 3366 4645 shahdakdadashpour@yahoo.com Sanandaj University of Medical Sciences Iran (Islamic Republic of) Patients with low sleep quality (score less than 5 based on global scores) Kidney failure, which has been dialyzed for at least 6 months signing Informed consent Kidney failure, which is dialyzed at least 3 times a week. Insomnia and or itching and or restless leg syndrome 18 to 70 years old 18 years 70 years Both Dissatisfaction with the company in the study Failure to cooperate in completing the Petersburg quality of sleep questionnaire People who have recived vitamins C, E, or multi-vitamins containing vitamin C, E or fish oil during the two months before the study A history of mental illness, severe heart and respiratory disease, or a history of infectious disease three months before the study began. Taking immunosuppressive drugs in the last two months. Patients who have undergone kidney transplantation and returned to hemodialysis. N18 G25.81 G47.00 Chronic kidney disease (CKD) Restless legs syndrome Insomnia, unspecified Rehabilitation Rehabilitation Intervention group: People who need dialysis which referring to dialysis department of Sanandaj Tohid Medical CenterThe intervention group received a 5-cc (500 milligram) vial of vitamin C from the Daropakhsh company Control group: People who need dialysis which referring to dialysis department of Sanandaj Tohid Medical Center. In the control group, 5 cc normal saline was given as a placebo for injection three times a week at the end of each dialysis session and intravenously for eight weeks. Itching. Timepoint: At the start of the study and after 8 weeks receiving the drug. Method of measurement: Level of itching according to VAS criteria. Restless leg syndrome. Timepoint: At the start of the study and after 8 weeks receiving the drug. Method of measurement: history taking and Clinical Evaluation. Sleep Quality. Timepoint: At the start of the study and after 8 weeks receiving the drug. Method of measurement: Pittsburgh Sleep Quality Standards Questionnaire (PSQI). Sanandaj University of Medical Sciences Approved 2016-04-08 Ethics committee of Kurdistan University of Medical Sciences pasdaran Blvd, opposite Shadi Hotel, Kurdistan University of Medical Sciences, Sanandaj, Management of Medical Researches and Information. POB 6617713446 sanandaj Kurdistan Iran (Islamic Republic of)