CompletedPhase 4

Gabapentin Versus Loratadine in Uremic Pruritus

Pakistan64 participantsStarted 2022-05-01

Plain-language 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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Four weeks

Trial details

NCT IDNCT05750875

SponsorKing Edward Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-10-31

View on ClinicalTrials.gov More Pruritus trials