Could a nerve pain drug stop diabetic itching?
NCT ID NCT06790537
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether pregabalin, a drug used for nerve pain, can reduce chronic itching in people with type 2 diabetes. 46 adults will receive either pregabalin plus moisturizer or a placebo plus moisturizer for 12 weeks. Researchers will measure itching severity and quality of life at follow-up visits.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- pregabalin
- What this could lead to
- If it works, this could offer a new treatment option for chronic itching in people with diabetes.
- What could go wrong
- This is a small, early-phase trial with only 46 participants, so results may not apply to everyone. Pregabalin can cause dizziness and drowsiness.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
About 46 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Apr 2025
- Expected to finish
-
Jun 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Diabetic pruritus are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
2 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Department of Endocrinology , PGIMER, Chandigarh
NOT_YET_RECRUITINGChandigarh, Chandigarh, 160012, India
-
Department of Endocrinology , PGIMER, Chandigarh
RECRUITINGChandigarh, Chandigarh, 160012, India
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Heartbeat test aims to catch hidden nerve damage in diabetes
- Can Home-Delivered meals help control diabetes?
- New pill takes aim at stubborn blood sugar
- Gene therapy shots aim to save legs from amputation in diabetes
- New pill takes aim at blood sugar in diabetes
- Can AI-Tailored heat warnings shield chronic disease patients from dangerous temperatures?