Gabapentin Versus Loratadine in Uremic Pruritus
Condition: Pruritus; Uremia; Chronic Kidney Diseases
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Pruritus
Study type: Interventional
Phase: Phase 4

Summary: 
      The goal of this clinical trial is to compare the efficacy of gabapentin with loratadine in
      reducing the severity of uremic pruritus in patients of chronic kidney disease and to compare
      the side effects of both drugs. The main questions it aims to answer are:

        -  Which drug (gabapentin versus loratadine) is more effective in reducing the severity of
           uremic pruritus?

        -  Which drug (gabapentin versus loratadine) has fewer side effects?

      Participants were divided into two groups.Group A received loratadine 10mg daily and group B
      received gabapentin 100mg daily. Both groups were given treatment for 4 weeks.

        -  Participants were asked to grade the severity of pruritus on a numerical rating scale
           and also answer the Dermatology Life Quality Index Questionnaire (DLQI)

        -  Participants were also asked to report any side effects, if occurred.

      Researchers compared both groups with regards to improvement in pruritus severity, DLQI score
      and side effects.
    

Detailed description: 
      Informed written consent was taken from all the participants. Participants were asked to
      discontinue any topical or systemic antipruritic drugs, for least 1 week prior to the study.
      Demographic, clinical and laboratory data (complete blood count, renal function tests, liver
      function tests, serum electrolytes and ultrasound abdomen) was evaluated at baseline.
      Glomerular Filtration Rate (GFR) and stage of chronic kidney disease was calculated.
      Participants were randomly allocated to two groups. One group received loratadine 10mg daily
      and the other received gabapentin 100mg daily. Those participants undergoing hemodialysis
      received their respective dose after the dialysis session. Both groups were given treatment
      for 4 weeks. Participants were asked to grade the severity of pruritus on a numerical rating
      scale and also answer the Dermatology Life Quality Index Questionnaire.These proformas were
      filled once at the start of the study, at 2 weeks and then at the end of study i.e. 4 weeks.
      Participants were also asked to report any adverse events, if occurred.

      The Statistical Package for the Social Sciences (SPSS) version 25.0 was used to analyze the
      data. Qualitative data (like gender, dialysis status, etc.) was expressed in the form of
      frequency and percentages while quantitative data (like age, weight, serum creatinine levels,
      etc.) was represented as mean and standard deviations (Mean±SD). The reduction in scores of
      numerical rating scale and Dermatology Life Quality Index Questionnaire was calculated from
      baseline. Mean reduction in scores were compared between the two groups and independent
      sample t-test was applied. p-value <0.05 was considered as significant.
    

Intervention name(s): Loratadine; Gabapentin
Intervention type(s): Drug; Drug
Intervention description(s): Participants were given loratadine 10mg, oral, daily, for 4 weeks; Participants were given gabapentin 100mg, oral, daily, for 4 weeks
Intervention MeSH terms: Loratadine; Gabapentin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Efficacy; Gabapentin; Loratadine; Uremic Pruritus