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IRCT20080916001256N3 IRCT 2021-03-14 Mashhad University of Medical Sciences The effect of energizing water on kidney function in patients with chronic kidney disease Assessing the effect of energetic water on kidney function in moderate to severe chronic kidney disease (CKD) patients 2021-04-10 anticipated 30 Complete https://irct.ir/trial/53982 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The permuted block technique was used to select patients in each of the treatment and control groups. Random blocks with variable sizes of 4 to 6 with a random sequence of colored leaves are designed in Random Allocation Software and are provided to the secretary in sealed packages.Each block consists of two to three people from the intervention group and two or three people from the control group. For each patient, one of the envelopes will be opened and the sheet on top is handed to the patient. According to the color of the paper, the patient will be categorized in one of the groups and will be registered in the relevant color list, Blinding description: The therapist and the patient do not know the type of the water and for both of them Water should be sent in exactly the same package and in equal volume. 2-3 Chronic Kidney disease. Intervention 1: Intervention group: Patients with moderate to severe CKD (GFR between 15 and 60) who meet the inclusion criteria after obtaining informed consent enter to study. They receive 1000 cc energetic water daily for three months, in addition to the usual treatments. Necessary tests are performed first and before treatment, in the middle of treatment and then at the end of three months. Kidney ultrasound will be performed at the beginning and end of the study. Intervention 2: Control group: Patients with moderate to severe CKD (GFR between 15 and 60) who meet the inclusion criteria after obtaining informed consent enter to study. They receive 1000 cc normal water daily for three months, in addition to the usual treatments. Necessary tests are performed first and before treatment, in the middle of treatment and then at the end of three months. Kidney ultrasound will be performed at the beginning and end of the study. Yes - There is a plan to make this available What will be shared: Unidentifiable data from individuals and related information will be shared with other researchers. Study protocol, data analysis program, etc, will be shared. When: Access to data is always available. To whom: All researchers are allowed to use. Conditions: The data can be used to research and provide new solutions by citing the source. Where to obtain: See the email of the researcher or the journal in which the article has been published How to obtain: Search in the Internet by using keywords and selecting titles or requesting them by sending an email to the researcher Comments:
public Dr Elahe Monazah
Ghaem Hospital, AhmadAbad Ave.
Mashhad Iran (Islamic Republic of) 91766-99199 +98 51 3801 2742 eli.mnzh@gmail.com Mashhad University of Medical Sciences scientific Dr Maryam Hami
Ghaem Hospital, AhmadAbad Ave.
Mashhad Iran (Islamic Republic of) 91766-99199 +98 51 3801 2738 hamim@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Chronic Kidney disease (CKD) patients( moderate to severe) Having informed consent to enter the study 18 years 60 years Both Uncontrolled Diabetes Mellitus (Hb A1C>7 & Fsting Blood Sugar>130 mg/dl) Uncontrolled hypertension ( systolic Blood pressure>160 & diastolic Blood Pressure >100 mmHg) Malignancies Obstructive Uropathy Stage 5 Chronic Kidney disease (CKD) active infection intake of Nephrotoxic drugs severe Congestive Heart Failure (Ejection Fraction<40%) Liver failure (cirrhosis) Poly cystic Kidney disease Pregnancy Renal transplantation Dissatisfaction with continued cooperation Smoking and drugs abuse Breastfeeding Accompanied by acute kidney diseases N18 Chronic kidney disease (CKD) Treatment - Other Treatment - Other Intervention group: Patients with moderate to severe CKD (GFR between 15 and 60) who meet the inclusion criteria after obtaining informed consent enter to study. They receive 1000 cc energetic water daily for three months, in addition to the usual treatments. Necessary tests are performed first and before treatment, in the middle of treatment and then at the end of three months. Kidney ultrasound will be performed at the beginning and end of the study. Control group: Patients with moderate to severe CKD (GFR between 15 and 60) who meet the inclusion criteria after obtaining informed consent enter to study. They receive 1000 cc normal water daily for three months, in addition to the usual treatments. Necessary tests are performed first and before treatment, in the middle of treatment and then at the end of three months. Kidney ultrasound will be performed at the beginning and end of the study. ُSerum Creatinine. Timepoint: 0-45-90 days. Method of measurement: Laboratory. Serum Lipid. Timepoint: 0-45-90 days. Method of measurement: Laboratory. Urine Protein. Timepoint: 0-45-90 days. Method of measurement: Laboratory. Hematuria. Timepoint: 0-45-90 days. Method of measurement: Laboratory. Serum Uric Acid. Timepoint: 0-45-90 days. Method of measurement: Laboratory. C-Reactive Protein (CRP). Timepoint: 0-45-90 days. Method of measurement: Laboratory. Liver Function test. Timepoint: 0-45-90 days. Method of measurement: Laboratory. Mashhad University of Medical Sciences Approved 2021-01-16 Ethics Committee of Mashhad University Of Medical sciences Vice President of Research, Ghoreshi building, Daneshgah st. Mashhad Razavi Khorasan Iran (Islamic Republic of)