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IRCT20200727048229N1 IRCT 2021-01-18 Birjand University of Medical Sciences The Effect of Aloe Vera gel, Violet oil and Hydroxyzine on pruritus and dry skin of hemodialysis patients Comparison of topical effect of Aloe Vera gel and Violet oil with Hydroxyzine for pruritus and dry skin of hemodialysis patients 2021-01-04 anticipated 45 Complete https://irct.ir/trial/52553 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: All sample subjects are divided into three equal groups by simple randomized methods. first 45 cards (equal to the number of sample volumes) will be prepared. Then, one of the letters A, B or C will be written on each card (15 cards A, 15 cards B and 15 cards C). These cards will be placed inside a box. so, no one will be able to see the cards inside the box. After shuffling the cards by the researcher, patients are asked to randomly remove a card from the box (selected cards will not be returned to the box after selection). Thus, Participants are divided into three groups of 15 members A, B and C. Also, to determine the type of intervention for each group in each stage, another randomization will be done by the researcher. In this way, three cards are prepared and one of the numbers one, 2 and 3 will be written on each card. Numbers 1, 2 and 3 will belong to Aloe Vera gel, Violet oil and Hydroxyzine tablets, respectively. These cards will placed in a box and after shuffling, the researcher will randomly select a card for each group (the selected cards will not be returned to the box after selection). For example, the researcher for group A randomly selects a card from the box. This card contains the number one. So in the first stage, the intervention of group A will be the use of Aloe Vera gel. In the same way, this process will be repeated for the other two groups and the next steps, Blinding description: In this study, the assistant researcher will complete the questionnaires to prevent bias in the results. Thus, the assistant researcher will be unaware of the groupings and the type of interventions performed in each group and by each Patient. N/A Condition 1: Uremic Pruritus. Condition 2: Uremic pruritus. Condition 3: Skin dryness. Condition 4: Dialysis. Condition 5: Chronic kidney disease. Intervention 1: In the first group, patients will be treated by 94% of SEAGULL's Aloe Vera gel twice per day for two weeks. Patients will use 3-5 cc of Aloe Vera gel to suit the dry and itchy area. After Wash out period the second treatment period will be continued by Violet oil made by Noshad Company twice per day for two weeks. Patients will use 3-5 cc of Violet oil to suit the dry and itchy area and after second Wash out period, the subjects will receive 10 mg Hydroxyzine tablets once a day (at night) for 2 weeks. Intervention 2: In the second group, patients will be treated by Violet oil made by Noshad Company twice per day for two weeks. Patients will use 3-5 cc of Violet oil to suit the dry and itchy area. After Wash out period, second treatment period will be continued by 10 mg Hydroxyzine tablets once a day (at night) for 2 weeks and after Wash out period, the subjects will receive 94% of SEAGULL's Aloe Vera gel twice per day for two weeks. Patients will use 3-5 cc of Aloe Vera gel to suit the dry and itchy area. Intervention 3: In the third group, patients will be treated by 10 mg Hydroxyzine tablets once a day (at night) for 2 weeks. After Wash out period, second treatment period will be continued by 94% of SEAGULL's Aloe Vera gel twice per day for two weeks. Patients will use 3-5 cc of Aloe Vera gel to suit the dry and itchy area and after Wash out period, the subjects will receive Violet oil made by Noshad Company twice per day for two weeks. Patients will use 3-5 cc of Violet oil to suit the dry and itchy area. Yes - There is a plan to make this available What will be shared: The total potential data can be shared after unidentifiable people When: Start the access period 6 months after printing the results To whom: Only for researchers working in academic and scientific institutions Conditions: Health Centers Where to obtain: Faculty of Nursing and Midwifery of Birjand How to obtain: Immediately by visiting the Library of Birjand University Of Medical Science Comments:
public Nima- RezaAliZadeh
Moallem Blvd, Birjand university of medical sciences
Birjand Iran (Islamic Republic of) 9717953577 +98 13 4486 1278 nimarezaaliazdeh@gmail.com Birjand University of Medical Sciences scientific Dr. Ahmad Nasiri
Moallem Blvd, Birjand university of medical sciences
Birjand Iran (Islamic Republic of) 9717953577 +98 56 3238 1406 nimarezaalizadeh@gmail.com Birjand University of Medical Sciences Iran (Islamic Republic of) 20 Years and older The cause of dialysis is Chronic Renal Failure. Patients undergoing hemodialysis for at least three months Undergoing hemodialysis at least twice a week history of pruritus for at least 4 weeks The severity of Itching according to the VAS scale is ≥3. The severity of Dry skin according to VAS scale is ≥3. Do not use other treatments to relieve Itching and Dry skin during the study including Radiation Therapy, Acupuncture, Complementary Medicine, Topical treatments, Moisturizing. The patient does not attend another Clinical Trial within the next two months. The absence of Pruritic and non-Pruritic skin diseases such as Atopic Dermatitis, Chronic Liver and Biliary disease, HIV, Polycythemia, Skin Eczema, No Inflammatory Skin Lesions, the absence of known allergies (based on Expert doctor's opinion) The absence of Pregnancy and lactation Informed consent 20 years no limit Both Unwillingness to continue participation in the study for any reason Severe side effects like an allergic reaction to the Aloe Vera gel or Violet oil in patients during the intervention Patient leaving the dialysis center during the study period (due to death, emigration, kidney transplantation). Using other treatments to relieve pruritus during the study including Radiation Therapy, Acupuncture, Complementary Medicine, Topical Treatments Acute disease during the intervention Do not perform interventions for more than one week continuously. According to the researcher's diagnosis, the person is excluded from the study. L29 L29 L85.3 Z49.1 N18 Pruritus Pruritus Xerosis cutis Dialysis (renal) Chronic kidney disease (CKD) Treatment - Drugs Treatment - Drugs Treatment - Drugs In the first group, patients will be treated by 94% of SEAGULL's Aloe Vera gel twice per day for two weeks. Patients will use 3-5 cc of Aloe Vera gel to suit the dry and itchy area. After Wash out period the second treatment period will be continued by Violet oil made by Noshad Company twice per day for two weeks. Patients will use 3-5 cc of Violet oil to suit the dry and itchy area and after second Wash out period, the subjects will receive 10 mg Hydroxyzine tablets once a day (at night) for 2 weeks. In the second group, patients will be treated by Violet oil made by Noshad Company twice per day for two weeks. Patients will use 3-5 cc of Violet oil to suit the dry and itchy area. After Wash out period, second treatment period will be continued by 10 mg Hydroxyzine tablets once a day (at night) for 2 weeks and after Wash out period, the subjects will receive 94% of SEAGULL's Aloe Vera gel twice per day for two weeks. Patients will use 3-5 cc of Aloe Vera gel to suit the dry and itchy area. In the third group, patients will be treated by 10 mg Hydroxyzine tablets once a day (at night) for 2 weeks. After Wash out period, second treatment period will be continued by 94% of SEAGULL's Aloe Vera gel twice per day for two weeks. Patients will use 3-5 cc of Aloe Vera gel to suit the dry and itchy area and after Wash out period, the subjects will receive Violet oil made by Noshad Company twice per day for two weeks. Patients will use 3-5 cc of Violet oil to suit the dry and itchy area. Dimensions of Pruritus. Timepoint: The day before the intervention and the day after the intervention. Method of measurement: 5-D itch scale. Intensity of emotions with itching. Timepoint: The day before the intervention and the day after the intervention. Method of measurement: Researcher-made questionnaire (intensity of emotions with itching). The consequences of itching. Timepoint: The day before the intervention and the day after the intervention. Method of measurement: Researcher-made questionnaire (The consequences of itching). The severity of itching. Timepoint: The day before the intervention and the day after the intervention. Method of measurement: Visual Analogue Scale (VAS). The severity of dry skin. Timepoint: The day before the intervention and the day after the intervention. Method of measurement: Visual Analogue Scale (VAS). Quality of life. Timepoint: at weeks 0 and 8. Method of measurement: Dermatology Life Quality Iindex (DLQI). Satisfaction rate of each intervention. Timepoint: The day after the end of each intervention. Method of measurement: Visual Analogue Scale (VAS). Birjand University of Medical Sciences Approved 2020-12-27 Ethics committee of Birjand University of Medical Sciences Moallem Blvd, Birjand university of medical sciences Birjand South Khorasan Iran (Islamic Republic of)