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

Study acronym: PREDICT
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
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.

Record History

  1. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Study sites: 1 to 2
    • Primary completion date: May 2026 to Jun 30, 2026
    • Study completion date: Jun 2026 to Jun 30, 2026
    • Start date changed from estimate of Jan 2025 to Apr 17, 2025
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06790537
Lead Sponsor Post Graduate Institute of Medical Education and Research, Chandigarh
Conditions
(from sponsor)		 Diabetic Pruritus, Efficacy of Pregabalin in Controlling Diabetic Pruritus Severity
Enrollment 46 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov