Efficacy of Pregabalin for Diabetic Pruritus - A Randomized Controlled Study.
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorPost Graduate Institute of Medical Education and Research, Chandigarh
About this trial
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 criteria
Qualifiers
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*
Disqualifiers
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.
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).
Severe psychiatric disorders that may interfere with the evaluation of pruritus or adherence to the study protocol.
Trial design
Treatments tested in this trial
- Pregabalin 75 mg
- Placebo Oral Capsule
Treatment groups
46 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov