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IRCT20110906007494N33 IRCT 2020-09-15 Mazandaran University of Medical Sciences The Effect of topical lipogel containing herbal extracts of Ziziphus jujuba and Echium amoenum on pruritus severity in hemodialysis patient Trial comparison of the effect of cutaneous lipogels containing Jujube and Echium amoenum plant extracts with placebo on the severity of pruritus in hemodialysis patients. 2020-10-11 anticipated 50 Complete https://irct.ir/trial/49967 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Supportive, Randomization description: Eligible patients will be randomly divided into two groups, group A and group B, using random number generation and computer software. With the computer program, the Randomization Blocked permuation method is applied and random blocks will be selected so that we will have 8 blocks of size 6 and one block of size 2. The patient number will be recorded on the medicine can, Blinding description: The researcher who evaluates the pruritus and also the patients do not know the contents of the medicine cans, only the pharmacist knows the contents of the cans. 3 Pruritus in hemodialysis patients. Intervention 1: Intervention group: Due to the fact that the study is a cross-over method, there are 25 people in each group. A group of 25 people with jujube and Echium amoenum lipogel will be replaced with a lipogel and placebo group after a two-week wash out period. Patients by unit FTU (one (FTU) is equal to the index finger to the first finger joint, lipogel removed from the tube with a diameter of 0.5 cm depending on the level of itching twice a day (morning (9 am) - night) 9 nights) so that a thin layer of lipogel is rubbed and spread on the itchy area of ​​the body for one minute and the amount of medicine used on each part of the body is recorded based on the fingerprint scale. The drug is stopped for two weeks for washout. Intervention 2: Control group: Patients who received placebo in the first stage of the drug (Ziziphus jujuba and Echium amoenum ) and the group who received the drug are given placebo and again patients in terms of severity of pruritus, distribution of pruritus and drug side effects for one week and up to four per week The following week, they are examined during a telephone call with patients. No - There is not a plan to make this available Justification or reason for not sharing IPD is no more information
public Dr.Masoumeh Bagheri Nesami
Vice chancellor for research, No 2 building, Mazandran University of Medical Sciences, Moalem street, Moalem square
Sari Iran (Islamic Republic of) 4815733971 +98 11 3565 2616 az_faraji200@yahoo.com Mazandaran University of Medical Sciences scientific Masoume Bagheri Nesami
Mazandaran University of Medical Sciences, Basij highway, Joibar three way, Imam square
Sari Iran (Islamic Republic of) 4816715793 +98 11 3565 2616 az_faraji200@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Hemodialysis patients aged 18 years and older End-stage renal disease undergoing regular dialysis treatment at least two or three times a week for six months Having itching in the last two weeks and having an itching intensity score using the Usipovich Itching Intensity Scale (ISS) in the range of severe and moderate pruritus Full alertness and ability to communicate Parathyroid hormone (PTH), <300 Phosphor(P) <6 18 years no limit Both Existence of wounds in the limbs Generalized limb edema (more than one plus (+1) Pregnancy Breastfeeding Other chronic diseases and cancer Taking other topical medications and antihistamines History of any allergies (skin, especially to plant compounds) L29.9 Pruritus, unspecified Treatment - Drugs Treatment - Drugs Intervention group: Due to the fact that the study is a cross-over method, there are 25 people in each group. A group of 25 people with jujube and Echium amoenum lipogel will be replaced with a lipogel and placebo group after a two-week wash out period. Patients by unit FTU (one (FTU) is equal to the index finger to the first finger joint, lipogel removed from the tube with a diameter of 0.5 cm depending on the level of itching twice a day (morning (9 am) - night) 9 nights) so that a thin layer of lipogel is rubbed and spread on the itchy area of ​​the body for one minute and the amount of medicine used on each part of the body is recorded based on the fingerprint scale. The drug is stopped for two weeks for washout. Control group: Patients who received placebo in the first stage of the drug (Ziziphus jujuba and Echium amoenum ) and the group who received the drug are given placebo and again patients in terms of severity of pruritus, distribution of pruritus and drug side effects for one week and up to four per week The following week, they are examined during a telephone call with patients. Pruritus. Timepoint: The first visit; the first, second, third and fourth weeks after starting to use lipogels. Method of measurement: Itching 48-point scale. Mazandaran University of Medical Sciences Approved 2020-07-21 Ethics Committee of Mazandaran University of Medical Sciences Vice chancellor for research, No 2 building, Mazandran University of Medical Sciences, Moalem street, Moalem square Sari Mazandaran Iran (Islamic Republic of)