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IRCT20171009036672N2 IRCT 2022-12-24 Vice President of Research and Technology Mashhad University of Medical Sciences Moisturizing effect of 12% ammonium lactate lotion in the treatment of dry skin in dialysis patients Formulation and Evaluation of the Moisturizing Effect of Ammonium Lactate 12% Lotion on Dermatological Disease of the Uremic Patients 2022-03-20 anticipated 25 Complete https://irct.ir/trial/63159 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: A double-blind randomized comparative clinical trial was conducted to investigate the effectiveness of ammonium lactate 12% against placebo lotion without medicinal substance. A study in the form of a questionnaire design related to the complications of uremic itching and the effect of 12% ammonium lactate lotion, which was provided to the participants and was filled again four weeks later by them to compare the effect of the lotion. The randomization method was done in a simple way and randomly in two groups. The randomization unit was checked individually in two different groups. The randomization tool was filled in the form of a hand skin evaluation questionnaire (expression of uremic itching side effects) before and after using the drug and for four weeks. Finally, using statistical software, the percentage of patients' satisfaction with the drug was evaluated. The way of constructing the random sequence was that the patients were randomly selected in two different groups Concealment was done in such a way that the patients did not know about the use of drugs or placebos, and drug distribution was done by the researcher . In this way, the first group used the drug (ammonium lactate 12%) and the second group used a placebo, i.e. a 50% w/w paraffin emulsion in water, Blinding description: The method of blinding was done in such a way that the participants, the ward nurse and the clinical supervisor were not aware of the drug or placebo, and the drug distribution was done by the researcher. Also, the person evaluating the outcome and the person analyzing the data did not know how to distribute the drug and placebo among the patients. In this way, the first group of participants used the drug (ammonium lactate 12%) in one day without knowing the name, and the second group used a placebo, i.e. 50% w/w paraffin emulsion in water. Patients were randomly selected according to uremic pruritus problems: the first group used medicine and the second group used placebo In this double-blind study, patients in both groups are evaluated before treatment and one month after using a hand skin stereomicroscope with 3x magnification in terms of visual scoring to determine the level of skin moisture and overall skin damage. This system has 6 grades, from 6 (normal skin without crusting and skin irritation) to 0 (skin cracks and wide fissures, redness or occasional bleeding) by the researcher and the ward nurse. 2 Severe dry skin. Intervention 1: Intervention group: The effectiveness of ammonium lactate 12% was investigated. A study in the form of a questionnaire design related to the complications of uremic itching and the effect of the drug, which was given to the participants and filled again four weeks later by them to compare the effect of the lotion. Intervention 2: control group: Placebo, lotion, placebo without medicinal substance, a study in the form of a questionnaire design related to the effects of uremic itching and the effect of the placebo, which was given to the participants and filled again four weeks later by them to compare the effect of the lotion. Yes - There is a plan to make this available What will be shared: How to improve patients can be presented in the form of a table When: Access period starts from the summer of 1401 for 6 months To whom: Researchers working in academic and scientific institutions Conditions: Available for medical purposes and through a doctor Where to obtain: emails How to obtain: The data will be emailed to them within a week Comments:
public atoosa haghighizadeh
pharmacy school, ferdowsi university of mashhad, park sq., montazer blv.
mashhad Iran (Islamic Republic of) 9188617871 +98 51 3180 1126 atoosa.hz@gmail.com Mashhad University of Medical Sciences scientific omid rajabi
pharmacy school, ferdowsi university of mashhad, park sq., montazeri blv.
mashhad Iran (Islamic Republic of) 9188617871 +98 51 3180 1126 rajabio@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Uric patient treated with peritoneal dialysis Existence of dry skin no limit no limit Both History of sensitivity to any of the components of the product Reluctance to participate or continue the plan Existence of skin diseases except dryness Treatment - Drugs Placebo Intervention group: The effectiveness of ammonium lactate 12% was investigated. A study in the form of a questionnaire design related to the complications of uremic itching and the effect of the drug, which was given to the participants and filled again four weeks later by them to compare the effect of the lotion. control group: Placebo, lotion, placebo without medicinal substance, a study in the form of a questionnaire design related to the effects of uremic itching and the effect of the placebo, which was given to the participants and filled again four weeks later by them to compare the effect of the lotion. Determining skin moisture. Timepoint: Before starting treatment and 3 days after taking the drug for a month. Method of measurement: The system has 6 degrees, from a score of 6 normal skin without scales ﴾to 0 degrees﴿ skin cracks. General skin damage. Timepoint: Before starting treatment and 3 days after taking the drug for a month. Method of measurement: The system has 6 degrees, from a score of 6 normal skin without scales ﴾to 0 degrees﴿ extensive fissures redness or occasional bleeding. Vice President of Research and Technology Mashhad University of Medical Sciences Approved 2019-05-19 Ethics Committee in Mashhad university of Medical Sciences Research Research and Technology Vice-Chancellor, next to Hoize Cinema, Qurashi Building, Mashhad, University St. mashhad Razavi Khorasan Iran (Islamic Republic of)