Clinical Trial

Efficacy of Pregabalin for Diabetic Pruritus - A Randomized Controlled Study.

Study acronym: PREDICT
Recruiting Phase 4
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Record status
This record was last updated January 5, 2026 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
Brief Summary: The goal of this randomized controlled study is to learn if pregabalin combined with emollients can reduce pruritus (itching) in people with Type 2 Diabetes Mellitus. The main questions it aims to answer are: Does pregabalin combined with emollients reduce pruritus severity compared to a placebo combined with emollients? What is the impact of pregabalin on the quality of life of participants suffering from diabetic pruritus? we will compare pregabalin plus emollient to a placebo plus emollient to see if pregabalin works better for reducing pruritus. Participants will: Receive either pregabalin 75 mg daily along with emollient therapy or a placebo along with emollient therapy. Visit the clinic at weeks 4, 8, and 12 for follow-up assessments, including: Pruritus severity using the Visual Analog Scale (VAS) and 5-D Itch Scale. Patient Global Impression of Change (PGIC) to measure overall improvement. This study will help determine if pregabalin, a drug used for neuropathic pain, can be an effective treatment for pruritus in people with diabetes.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-01-18.
Status change: Not Yet Recruiting → Recruiting 2025-12-30
Trial Details
NCT Number NCT06790537
Lead Sponsor Post Graduate Institute of Medical Education and Research, Chandigarh
Conditions Diabetic Pruritus, Efficacy of Pregabalin in Controlling Diabetic Pruritus Severity
Enrollment 46 participants
Start Date 2025-04-17
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-01-05