Actively Recruiting
Efficacy of Pregabalin for Diabetic Pruritus - A Randomized Controlled Study.
Led by Post Graduate Institute of Medical Education and Research, Chandigarh · Updated on 2026-01-05
46
Participants Needed
2
Research Sites
62 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Efficacy of Pregabalin for Diabetic Pruritus - A Randomized Controlled Study.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults older than 18 years with Type 2 Diabetes Mellitus
- HbA1c less than 10% with stable medication for at least 1 month before enrollment
- Chronic itching lasting six weeks or longer
- Itching affecting two or more major body areas as per the 5-D Itch Scale
- Baseline Visual Analog Scale (VAS) score of 5 or higher
You will not qualify if you...
- Type 1 Diabetes Mellitus, gestational diabetes, pregnant or breastfeeding women
- Itching lasting less than six weeks
- Itching caused by conditions like severe kidney disease (CKD stage IV/V), liver disease, viral hepatitis, HIV, uncontrolled thyroid disorders, or myeloproliferative disorders
- Itching caused by primary skin diseases such as eczema, psoriasis, lichen planus, or other skin disorders with lesions
- Recent use (within 2 weeks) of systemic medications affecting itching, including gabapentins, tricyclic antidepressants, antihistamines, corticosteroids, or calcineurin inhibitors
- Known allergy or hypersensitivity to pregabalin or emollients
- Severe psychiatric disorders that could affect study participation or evaluation
- Immunocompromised status such as post-transplant or on immunosuppressive therapy
- Itching due to other causes like notalgia paresthetica, post-burn pruritus, or opioid-induced pruritus
- Substance abuse disorders
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Department of Endocrinology , PGIMER, Chandigarh
Chandigarh, Chandigarh, India, 160012
Not Yet Recruiting
2
Department of Endocrinology , PGIMER, Chandigarh
Chandigarh, Chandigarh, India, 160012
Actively Recruiting
Research Team
K
KARTHIK N Dr, MBBS DNB General medicine
CONTACT
A
Ashu Rastogi, DM Endocrinology
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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