Gabapentin Versus Loratadine in Uremic Pruritus

Sponsor

King Edward Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT05750875

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

10.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pruritus Uremia Chronic Kidney Diseases	Drug: Loratadine Drug: Gabapentin	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Comparison of the Efficacy of Gabapentin With Loratadine in the Treatment of Uremic Pruritus in Patients of Chronic Kidney Disease

Actual Study Start Date :

May 1, 2022

Actual Primary Completion Date :

Oct 31, 2022

Actual Study Completion Date :

Oct 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Loratadine	Drug: Loratadine Participants were given loratadine 10mg, oral, daily, for 4 weeks
Active Comparator: Gabapentin	Drug: Gabapentin Participants were given gabapentin 100mg, oral, daily, for 4 weeks

Arm

Intervention/Treatment

Active Comparator: Loratadine

Drug: Loratadine

Participants were given loratadine 10mg, oral, daily, for 4 weeks

Active Comparator: Gabapentin

Drug: Gabapentin

Participants were given gabapentin 100mg, oral, daily, for 4 weeks

Outcome Measures

Primary Outcome Measures

Mean reduction in pruritus score, from baseline till 4 weeks, as measured on a numerical rating scale. [Four weeks]

Secondary Outcome Measures

Mean reduction in DLQI score, from baseline till 4 weeks, as measured by Dermatology Life Quality Index Questionnaire. [Four weeks]
Comparison of side effects of gabapentin and loratadine, as reported by the participants. [Four weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Chronic kidney disease, stage 3 and above, irrespective of dialysis status
Persistent pruritus, of moderate to very severe intensity (≥ 4 points on numerical rating scale), occurring at least 3 times a week, for at least 2 weeks, in a 1-month period.

Exclusion Criteria:

Chronic skin conditions such as eczema, psoriasis, etc.
Pruritus due to any other cause, such as metabolic abnormalities, liver disease, etc.
History of drugs causing pruritus such as opioids, etc
Pregnant patients
Preceding history of allergy to either gabapentin or loratadine.