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IRCT20220516054879N8 IRCT 2023-11-04 Rasht University of Medical Sciences Effects of topical Gabapentin 6% cream and placebo on uremic pruritus in hemodialysis patients Study of the effect of 6 % Gabapentin topical cream on uremic pruritus in maintenance hemodialysis patients a randomized double-blind placebo controlled clinical trial 2023-10-20 anticipated 68 Complete https://irct.ir/trial/73260 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be entered into each of the 2 drug (A) and placebo (B) treatment groups using the block randomization method with a ratio of 1:1. Randomization will be done in such a way that each patient will be assigned number 1 to 68. Then a table that has 17 rows called blocks and each block will have 4 parts and each part will be named A and B will be considered. In the next step, the numbers are placed in each house in order. After all the numbers are placed in the blocks, the people who have numbers in house A will receive the drug and the people who have numbers in house B will receive placebo. The website https://www.sealedenvelope.com is used for randomization. For allocation concealment, opaque-sealed envelopes will be used, Blinding description: This is a double-blind study. The type of treatment will be placed inside a sealed envelope and delivered to the nurse and statistical analyst. The researcher and the participant will be blind. 3 Uremic pruritus. Intervention 1: Intervention group: Receiving a 6% gabapentin topical cream once a day for 1 month. Intervention 2: Control group: Receiving a placebo (cold cream) once a day for 1 month. No - There is not a plan to make this available Justification or reason for not sharing IPD is Patient privacy and ethical principles
public Maryam Shahrokhi
17shahrivar Hospital, Shahid Siadati Street, Namjoo Street
Rasht Iran (Islamic Republic of) 4144654379 +98 13 3336 9019 shahrokhi.mail85@gmail.com Rasht University of Medical Sciences scientific Maryam Shahrokhi
17shahrivar Hospital, Shahid Siadati Street, Namjoo Street
Rasht Iran (Islamic Republic of) 4144654379 +98 13 3336 9019 shahrokhi.mail85@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) Patients over 18 years old who are undergoing hemodialysis treatment (at least 2 times a week and for at least 8 weeks). Patients who scored higher than 5 in the 11-point VAS scale. Obtaining informed consent 18 years no limit Both Patients who have been treated with antihistamines and emollients. Patient sensitivity to gabapentin or placebo Pregnancy Breastfeeding L29.9 Pruritus, unspecified Treatment - Drugs Placebo Intervention group: Receiving a 6% gabapentin topical cream once a day for 1 month Control group: Receiving a placebo (cold cream) once a day for 1 month Duration of itching during the day and night. Timepoint: The duration of itching during the day and night is measured at the beginning of the study and then in the second and fourth weeks. Method of measurement: Based on questions from the patient using the 5D-itch questionnaire. Intensity of itching. Timepoint: The intensity of itching is measured at the beginning of the study and then in the second and fourth weeks. Method of measurement: Based on questions from the patient using the 5D-itch questionnaire. Sleep quality. Timepoint: The effect of itching on sleep quality is measured at the beginning of the study and then in the second and fourth weeks. Method of measurement: Based on questions from the patient using the 5D-itch questionnaire. Quality of social relationships. Timepoint: The effect of itching on the quality of social relationships is measured at the beginning of the study and then in the second and fourth weeks. Method of measurement: Based on questions from the patient using the 5D-itch questionnaire. Quality of presence at work or home. Timepoint: The effect of itching on the quality of being at work or at home is measured at the beginning of the study and then in the second and fourth weeks. Method of measurement: Based on questions from the patient using the 5D-itch questionnaire. The number of areas affected by itching. Timepoint: The effect of the number of areas affected by itching is measured at the beginning of the study and then in the second and fourth weeks. Method of measurement: Based on questions from the patient using the 5D-itch questionnaire. General condition of uremic itching in patients during one month. Timepoint: The general condition of uremic itching of patients is measured at the beginning of the treatment and then in the second and fourth weeks. Method of measurement: Based on asking the patient using the VAS scale. Rasht University of Medical Sciences Approved 2023-10-18 Ethics committee of Guilan University of Medical Sciences Deputy of research and technology, In front of 17 shahrivar hospital, Shaid siadati street,Namjoo street, Rasht Rasht Guilan Iran (Islamic Republic of)