Efficacy of Pregabalin for Diabetic Pruritus - A Randomized Controlled Study.
Post Graduate Institute of Medical Education and Research, Chandigarh
46 participants
Apr 17, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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.
Exclusion Criteria17
- Types of Diabetes:
- o Gestational Diabetes, pregnant and breastfeeding women with T2DM, Type 1 DM.
- Pruritus Duration and Causes:
- Pruritus of less than six weeks' duration.
- Pruritus associated with systemic conditions such as uraemia (CKD stage IV/V), cholestatic liver diseases, viral hepatitis, HIV infection, uncontrolled hypothyroidism* or hyperthyroidism\^, myeloproliferative disorders, Chronic venous insufficiency in legs or Postherpetic pruritus.
- *Uncontrolled hypothyroidism - T3 / T4 below the upper limit of normal.
- \^Uncontrolled hyperthyroidism- T3/T4 above the upper limit of normal.
- Pruritus due to primary dermatological disorders presenting with skin lesions (e.g., atopic dermatitis, eczema, psoriasis, allergic contact dermatitis, urticarial disorders, lichen planus, prurigo nodularis, asteatotic dermatitis).
- Use of Medications Affecting Pruritus:
- o Current or recent use (within 2 weeks before study initiation) of systemic treatments that may impact pruritus, including gabapentins (e.g., pregabalin, gabapentin), tricyclic antidepressants (TCA), antihistamines, corticosteroids, and calcineurin inhibitors.
- Rationale: Since these medications are commonly used for neuropathic pain or Pruritus which coexists with diabetic pruritus, their recent use may affect pruritus severity and treatment response. Patients using these drugs for neuropathic pain or other conditions should undergo a washout period of 2 weeks before study initiation.
- Drug Hypersensitivity and Reactions:
- o Known allergies or hypersensitivity to pregabalin or emollient.
- Psychiatric and Immunocompromised Status:
- Severe psychiatric disorders that may interfere with the evaluation of pruritus or adherence to the study protocol.
- Immunocompromised patients (e.g., post-transplant, immunosuppressive therapy). Pruritus due to Notalgia paresthetica or brachioradial pruritus, post burn pruritus, opioid-induced pruritus.
- People with Substance abuse disorders.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
75 mg of pregabalin will be given at night for the intervention group along with emollient local application
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 .
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06790537