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Study aim
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Determination and comparison of serum phosphorus, serum calcium, serum PTH, serum sodium, serum potassium, serum creatinine, blood urea, serum albumin, serum triglycerides, ALT, AST, complete blood count and total bilirubin levels in two groups treated with paroxetine and sertraline.
Determination and comparison of pruritus in ESRD patients undergoing hemodialysis in two groups treated with paroxetine and sertraline.
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Design
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A phase 2, randomized, controlled clinical trial with parallel-group design, conducted on 62 patients. A random number table was used for randomization.
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Settings and conduct
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This randomized clinical trial will be conducted on 62 hemodialysis patients at Hajar Hospital. Using a random number table, participants will be randomly allocated into two groups: Group A: paroxetine 10 mg during the first week and 20 mg during the second to fourth weeks, and Group B: sertraline 25 mg during the first week and 50 mg during the following three weeks.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Informed consent of the patient to participate in the study, Ages 18 to 80 years, ESRD patients with mild, moderate, or severe pruritus, No alcohol consumption, At least four weeks after diagnosis
Exclusion criteria: Use of other antipruritic medications, history of skin diseases that may cause pruritus and not related to uremic pruritus, thyroid disease, liver disease, systemic lupus erythematosus, parathyroid hormone (PTH) > 450 pg/ml
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Intervention groups
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Group A : paroxetine 10 mg for the first week, 20 mg for the second, third and fourth weeks.
Group B: sertraline 25 mg for the first week and 50 mg for the remaining three weeks.
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Main outcome variables
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Serum phosphorus, serum calcium, serum PTH, serum sodium, serum potassium, serum creatinine, blood urea, serum albumin, serum triglycerides, ALT, AST, complete blood count and total bilirubin, and itching level