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IRCT20201228049866N1 IRCT 2021-01-06 Yasouj University of Medical Sciences The effect of watercress on hemodialysis patients The effect of hydroalcoholic extract of Nasturtium officinale on level of vitamin C and E, protein carbonyl and inflammatory markers in chronic hemodialysis patients. 2021-01-20 anticipated 75 Complete https://irct.ir/trial/53340 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Patients undergoing chronic hemodialysis referred to Shahid Beheshti Hospital in Yasouj are randomly divided into two groups (control group and intervention group) with a ratio of 1.1. The amount of 500 mg of hydroalcoholic extract of watercress and placebo is given daily to the intervention and control groups for 4 weeks, respectively. Patients' weight and height were measured by a nurse who was blind to the groups. In serum samples taken at the beginning and end of the dialysis session, serum levels of carbonyl protein, inflammatory markers, and vitamins E and C are determined, Randomization description: In this study, we will use the Restricted randomization method of the randomization Random allocation rule method. For this purpose, first determine a total sample size, then randomly assign a set of them to the intervention group and the rest to the control group.35balls for the intervention group and 35balls for the control group are placed in a lottery container and then the balls are randomly removed from the container without replacement and the created sequence is recorded, Blinding description: Capsules are individually packed envelopes and have an identification number. Capsules and envelopes of Nasturtium officinale extract and placebo are offered in exactly the same appearance and packaging, which will blind the participants and the researcher. 3 Patients undergoing chronic hemodialysis. Intervention 1: Intervention group: During a four weeks’ period, the patients in intervention group take 500 mg hydroalcoholic extract of WC once a day and those in control group receive drug-like (capsule color, packing) containing 500 mg of white flour. Hydroalcoholic extract of WC dose select according to previous clinical and pharmacologic studies. At the end of each week, the patient’s drug box control for confounding drugs. The patients check for WC side effects based on the dialysis frequency of at least three times a week. Patients monitor weekly for drug use for the assurance of clinical research, and they ask to bring the empty container. Intervention 2: Control group: Take a placebo of 500 mg daily for 4 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more informtion
public Amir Hossein Doustimotlagh
Saheli Ave., Imam Sajjad Hospital, Yasouj University of Medical Sciences
Yasuj Iran (Islamic Republic of) 7591994799 +98 74 3334 6070 amirhosseindoustimotlagh@gmail.com Yasouj University of Medical Sciences scientific Amir Hossein Doustimotlagh
Saheli Ave., Imam Sajjad Hospital, Yasouj University of Medical Sciences
Yasuj Iran (Islamic Republic of) 7591994799 +98 74 3334 6070 amirhosseindoustimotlagh@gmail.com Yasouj University of Medical Sciences Iran (Islamic Republic of) 18 years of age and older Receive hemodialysis at least twice a week for about 3 months Negative history of taking drugs affecting inflammatory markers such as corticosteroids and nonsteroidal anti-inflammatory drugs (NSAIDs) in a recent month Absence of active infectious diseases, malignant and other obvious inflammatory diseases No history of taking tonics and anti-inflammatory drugs 18 years 65 years Both Causes unpredictable drug side effects Patients who refused to cooperate and continue the study and received the drug for less than 4 weeks Development of active infectious diseases, cirrhosis and congestive heart failure and malignancy during the study and the need for kidney transplantation Malnutrition and cachexia (body mass index less than 18 kg / m2) Albumin less than 3 Z49.31 Encounter for adequacy testing for hemodialysis Treatment - Other N/A Intervention group: During a four weeks’ period, the patients in intervention group take 500 mg hydroalcoholic extract of WC once a day and those in control group receive drug-like (capsule color, packing) containing 500 mg of white flour. Hydroalcoholic extract of WC dose select according to previous clinical and pharmacologic studies. At the end of each week, the patient’s drug box control for confounding drugs. The patients check for WC side effects based on the dialysis frequency of at least three times a week. Patients monitor weekly for drug use for the assurance of clinical research, and they ask to bring the empty container. Control group: Take a placebo of 500 mg daily for 4 weeks Blood urea nitrogen. Timepoint: 0-28 days. Method of measurement: Autoanalyzer. Triglyceride. Timepoint: 0-28 days. Method of measurement: Autoanalyzer. Cholestrol. Timepoint: 0-28 days. Method of measurement: Autoanalyzer. Protein carbonyl. Timepoint: 0-28 days. Method of measurement: colorimetric. Interleukin 6. Timepoint: 0-28 days. Method of measurement: Sandwich Enzyme-Linked ImmunoSorbent Assay. Tumor Necrosis Factor Alpha(TNF-α). Timepoint: 0-28 days. Method of measurement: Sandwich Enzyme-Linked ImmunoSorbent Assay. Vitamin E. Timepoint: 0-28 days. Method of measurement: High-performance liquid. Vitamin C. Timepoint: 0-28 days. Method of measurement: High-performance liquid. Yasouj University of Medical Sciences Approved 2019-11-02 Ethics comittee of Yasuj University of Medical Sciences Saheli Ave., Imam Sajjad Hospital, Yasouj University of Medical Sciences Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)