Pregabalin with emollients for treating itching in type 2 diabetes
Efficacy of Pregabalin for Diabetic Pruritus - A Randomized Controlled Study.
This trial tests whether pregabalin taken with emollients can reduce bothersome itching in adults with type 2 diabetes.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Post Graduate Institute of Medical Education and Research, Chandigarh Academic / other |
| Locations | 2 sites (Chandigarh, Chandigarh and 1 other locations) |
| Trial ID | NCT06790537 on ClinicalTrials.gov |
What this trial studies
This is a randomized, double-blind, placebo-controlled Phase 4 trial comparing pregabalin 75 mg once daily plus emollient therapy to placebo plus emollient in adults with type 2 diabetes and chronic pruritus. Participants must have pruritus lasting at least six weeks with a baseline VAS score of ≥5 and will attend clinic visits at weeks 4, 8, and 12 for follow-up assessments. Primary outcomes include change in pruritus severity measured by the Visual Analog Scale and the 5-D Itch Scale, with secondary measures such as Patient Global Impression of Change and quality of life. Key exclusions include type 1 or gestational diabetes, pregnancy or breastfeeding, short-duration pruritus, or pruritus clearly due to other systemic causes.
Who should consider this trial
Good fit: Adults with type 2 diabetes on stable medication (HbA1c <10%), chronic pruritus for six weeks or longer affecting multiple body areas, and a baseline VAS score of at least 5.
Not a fit: People with type 1 or gestational diabetes, pregnant or breastfeeding individuals, those with pruritus under six weeks, or pruritus caused by other identified systemic conditions are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If effective, pregabalin plus emollients could provide a tolerable oral treatment that reduces chronic diabetic itching and improves patients' quality of life.
How similar studies have performed: Pregabalin has shown benefit in other neuropathic itch and pain conditions, but evidence specifically for diabetic pruritus is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Adults (\>18 years) with Type 2 Diabetes Mellitus
2. HbA1c \<10% and on stable medication for at least 1 month before enrolment.
3. Presence of chronic pruritus (lasting for six weeks or longer) \[2\].
4. Generalized or localised pruritus affecting more than one major body area\*
5. 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 Criteria:
1. Types of Diabetes:
o Gestational Diabetes, pregnant and breastfeeding women with T2DM, Type 1 DM.
2. 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).
3. 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.
4. Drug Hypersensitivity and Reactions:
o Known allergies or hypersensitivity to pregabalin or emollient.
5. 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.
6. People with Substance abuse disorders.
Where this trial is running
Chandigarh, Chandigarh and 1 other locations
- Department of Endocrinology , PGIMER, Chandigarh — Chandigarh, Chandigarh, India (Not_yet_recruiting)
- Department of Endocrinology , PGIMER, Chandigarh — Chandigarh, Chandigarh, India (Recruiting)
Study contacts
- Principal investigator: Ashu Rastogi, DM ENDOCRINOLOGY — Post Graduate Institute of Medical Education and Research, Chandigarh
- Study coordinator: KARTHIK N Dr, MBBS DNB General medicine
- Email: nalam.karthik8788@gmail.com
- Phone: +91 9492115369
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.