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IRCT20191231045958N1 IRCT 2020-04-12 Mazandaran University of Medical Sciences The effect of locally administered Sambucus ebulus gel 5% on the severity and extention of pruritus in hemodialysis patients The effect of locally administered Sambucus ebulus gel 5% on the severity and extention of pruritus in hemodialysis patients 2020-04-20 anticipated 150 Complete https://irct.ir/trial/44648 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients were randomly assigned to each group using Permuted block Randomization as follows. We select 25 blocks of 6. The blocks will be from 120 different modes such as AABBCC, AABCBC, AACBCB, ABCABC, BABCAC, ACBBCA. In each block there will be two cases of group A and two cases of group B and two cases of group C. The computer program selects one randomly each time and the order of people in the groups is random, Blinding description: The person evaluating the severity of the itch is an unaware product. 2 Pruritus in hemodialysis patients. Intervention 1: The aim of this study was to investigate the effect of locally administered sambucus ebulus gel 5% on the severity and extention of pruritus hemodialysis patients.Three groups of patients are examined, in each group there are 50 hemodialysis patients. The first group uses sambucus ebulus 5% gel - the second group uses placebo gel and the third group is without intervention. sambucus ebulus gel prepared in the laboratory of Mazandaran University of Medical Sciences .After preparing the gel, Patients in both the intervention and placebo groups are taught to use the gel twice a day, morning and night, for 8 weeks.So as to cover the itchy area.Intervention group: Topical product containing 5% sambucus ebulus extract, twice daily for two months. Intervention 2: Control group: placebo gel. Fifty hemodialysis patients who are randomly assigned to this group use placebo gel prepared at the Faculty of Pharmacy, Mazandaran University. These patients are also taught to use the gel twice a day, morning and night, at home for 8 weeks to cover the itchy area. Intervention 3: Without intervention-This group was considered for the psychological dimension of drug use in patients with severe itching. Yes - There is a plan to make this available What will be shared: Patient data - Demographic information and itching score at each stage in each group When: Data will be available after the study and statistical analysis. To whom: There is no limit. Conditions: In order to conduct similar studies Where to obtain: Dr.Hedayat jafari How to obtain: 0 Comments:
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Sari Iran (Islamic Republic of) ۴۸۱۶۷۱۵۷۹۳ ۳۳۳۶۷۳۴۲ h_saberian@yahoo.com Mazandaran University of Medical Sciences scientific Hedayat jafari
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Sari Iran (Islamic Republic of) ۴۸۱۶۷۱۵۷۹۳ ۳۳۳۶۷۳۴۲ Hedayat2003@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients over 18 years who have been undergoing hemodialysis for more than 3 months Patients who have had itching at least 3 times in the last 2 weeks Despite drug use in the last month of treatment, no evidence of improvement was observed Patients undergo hemodialysis 3 days a week for 3–5 hours per session Have no skin problems other than uremic itching Patients who gave their written consent to participate in the project Patients who do not use another method to reduce the severity of itching Lack of systemic diseases such as liver cholestatic, hepatitis B, HIV thyroid disorders and women who are not pregnant and breastfeeding Lack of cognitive impairments that cannot answer questions 18 years no limit Both If the patient undergoes kidney transplantation during the study If there is allergy to sambucus ebulus gel Patients who do not wish to continue the study for personal reasons Patients with a phosphorus test range of more than 6 and a PTH of more than 300 L29.9 Pruritus, unspecified Treatment - Drugs Placebo Other The aim of this study was to investigate the effect of locally administered sambucus ebulus gel 5% on the severity and extention of pruritus hemodialysis patients.Three groups of patients are examined, in each group there are 50 hemodialysis patients. The first group uses sambucus ebulus 5% gel - the second group uses placebo gel and the third group is without intervention. sambucus ebulus gel prepared in the laboratory of Mazandaran University of Medical Sciences .After preparing the gel, Patients in both the intervention and placebo groups are taught to use the gel twice a day, morning and night, for 8 weeks.So as to cover the itchy area.Intervention group: Topical product containing 5% sambucus ebulus extract, twice daily for two months Control group: placebo gel. Fifty hemodialysis patients who are randomly assigned to this group use placebo gel prepared at the Faculty of Pharmacy, Mazandaran University. These patients are also taught to use the gel twice a day, morning and night, at home for 8 weeks to cover the itchy area. Without intervention-This group was considered for the psychological dimension of drug use in patients with severe itching. Pruritus. Timepoint: first visit-The fourth and eighth week after starting to use the gel. Method of measurement: 48-point scale for itching severity. Skin dryness. Timepoint: first week, The fourth and eighth week after starting to use the gel. Method of measurement: Examination. Mazandaran University of Medical Sciences Approved 2020-03-11 Ethics Committee of Mazandaran University of Medical Sciences Moalem Square Sari Mazandaran Iran (Islamic Republic of)