Efficacy of Pregabalin for Diabetic Pruritus - A Randomized Controlled Study.
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.
• Adults (\>18 years) with Type 2 Diabetes Mellitus
• HbA1c \<10% and on stable medication for at least 1 month before enrolment.
• Presence of chronic pruritus (lasting for six weeks or longer) \[2\].
• Generalized or localised pruritus affecting more than one major body area\*
• Baseline VAS score of ≥5 $ \*Pruritus including Generalized or localized pruritus as long as it involves two or more areas as per the 5D Itch Scale distribution \[Head/scalp, face, chest, abdomen, back, buttocks, thighs, lower legs, feet/toes, arms, palms, hands/fingers, groin, and clothing contact points (waistbands/undergarments).
⁃ $ Baseline VAS score of ≥5 is included to ensure sufficient severity of pruritus for measurable improvement.