Efficacy of Pregabalin for Diabetic Pruritus - A Randomized Controlled Study.

NCT06790537 | Recruiting Phase 4 DMC

• 1 other identifier: PREDICT
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Diabetic Pruritus; Efficacy of Pregabalin in Controlling Diabetic Pruritus Severity

Keywords

Efficacy of pregabalin for control of generalised pruritus in Diabetic patients

Outcome Measures

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.

  12 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

Pregabalin with emollient group. Pregabalin 75 mg one dose at night plus emollient application in the morning after bathing.

Drug: Pregabalin 75 mg

placebo arm

PLACEBO COMPARATOR

Placebo pill identical in appearance to the pregabalin capsule and standard treatment with emollient application locally on the areas of itching .

Other: Placebo Oral Capsule

Interventions

Pregabalin 75 mg DRUG

75 mg of pregabalin will be given at night for the intervention group along with emollient local application

Intervention group

Placebo Oral Capsule OTHER

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 .

placebo arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (2)

Department of Endocrinology , PGIMER, Chandigarh

Chandigarh, Chandigarh, 160012, India

NOT YET RECRUITING

Department of Endocrinology , PGIMER, Chandigarh

Chandigarh, Chandigarh, 160012, India

RECRUITING

MeSH Terms

Interventions

Pregabalin

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Ashu Rastogi, DM ENDOCRINOLOGY

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

KARTHIK N Dr, MBBS DNB General medicine

CONTACT

+91 9492115369; nalam.karthik8788@gmail.com

Ashu Rastogi, DM Endocrinology

CONTACT

9781001046; ashuendo@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 18, 2025
• First Posted: January 24, 2025
• Study Start: April 17, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 5, 2026

Record last verified: 2025-01

Locations

IN (2)