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

NCT06790537 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2026-01-05

No results posted yet for this study

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.

Conditions

  • Diabetic Pruritus
  • Efficacy of Pregabalin in Controlling Diabetic Pruritus Severity

Interventions

DRUG

Pregabalin 75 mg

75 mg of pregabalin will be given at night for the intervention group along with emollient local application

OTHER

Placebo Oral Capsule

placebo capsule will be identical in appearance to the pregabalin capsule. it will be given at the same time of the day like pregabalin. same Emollient which is used in the Intervention arm will be applied locally on the areas of itching, morning after bathing .

Sponsors & Collaborators

  • Post Graduate Institute of Medical Education and Research, Chandigarh

    lead OTHER

Principal Investigators

  • Ashu Rastogi, DM ENDOCRINOLOGY · Post Graduate Institute of Medical Education and Research, Chandigarh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-17
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06790537 on ClinicalTrials.gov