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Can a drug combo tame diabetic nerve pain with fewer side effects?

NCT ID NCT07785544

Symptom relief Sponsor: Bangladesh Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 25, 2026 · Last updated Aug 27, 2026 · Updated 2 times

Summary

This trial tests whether a lower dose of duloxetine combined with alpha-lipoic acid can relieve painful diabetic peripheral neuropathy as effectively as the standard higher dose of duloxetine alone. Adults with diabetes and nerve pain will be randomly assigned to one of the two treatments for nine weeks. The main goal is to see if the combination reduces pain scores as well as the standard treatment, while potentially offering better tolerability.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Duloxetine combined with alpha-lipoic acid
What this could lead to
If effective, this combination could offer a way to manage diabetic nerve pain with fewer side effects than standard-dose duloxetine.
What could go wrong
This is a relatively small trial, and the combination might not prove as effective as the standard dose. Duloxetine can cause side effects like nausea or dizziness.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 170 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 2027

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥18 years. * Diagnosed case of diabetes mellitus. * Diabetic peripheral neuropathy diagnosed clinically according to the Toronto Clinical Neuropathy Score (TCNS) criteria with a TCNS score ≥6, with painful neuropathy confirmed using the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Pain Scale with a score ≥12. * Duration of neuropathic symptoms ≥3 months. * Baseline Numerical Rating Scale (NRS) pain score ≥4. * Willingness to participate in the study and provide written informed consent. Exclusion Criteria: * Pain attributable to causes other than diabetic peripheral neuropathy, such as peripheral arterial disease (ischaemic pain), osteoarthritis, inflammatory arthritis, phantom limb pain, radiculopathy, or other chronic pain disorders. * Known vitamin B12 deficiency, hypothyroidism, chronic alcohol use, hereditary neuropathy, chemotherapy-induced neuropathy, HIV infection, or connective tissue disease. * Chronic kidney disease (CKD) stage ≥4. * Chronic liver disease or significant hepatic impairment (ALT \>3 times the upper normal limit). * Use of antidepressants, antiepileptic drugs, sedatives, antipsychotic drugs, or opioids within the preceding 4 weeks. * Pregnancy or lactation, or women planning pregnancy during the study period. * Known hypersensitivity or contraindication to duloxetine or alpha-lipoic acid. * Major depressive disorder as assessed by the Patient Health Questionnaire-9 (PHQ-9), cognitive impairment (MMSE \<24), active malignancy, or any serious medical condition that, in the opinion of the investigator, may interfere with study participation, treatment adherence, or outcome assessment.

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Conditions

The condition(s) this trial relates to.

diabetic neuropathy diabetic polyneuropathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Painful diabetic peripheral neuropathy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Chittagong Medical College Hospital (CMCH)

    Chittagong, 4203, Bangladesh

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