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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Pregabalin 75 mg
Drug75 mg of pregabalin will be given at night for the intervention group along with emollient local application
Placebo Oral Capsule
Other interventionplacebo 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 .
Treatment groups
46 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 1 intervention
Group B: placebo armPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
• Mean change in VAS (Visual analogue scale)scores from baseline to week 12 between the two groups.
For all patients baseline VAS score will be assessed , then for both the intervention groups , follow up VAS scores will be noted at week 4, 8 and 12 weeks. Mean change in VAS scores in both the groups before and after the intervention will be the Primary outcome.
Time frame
12 weeksSponsors and contacts
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Source ClinicalTrials.gov