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Can a supplement stop the ringing? new trial targets brain inflammation in tinnitus

NCT ID NCT06718452

Symptom relief Sponsor: University of Campania Luigi Vanvitelli Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether umPEALUT, a supplement that reduces inflammation, can help people with tinnitus. The researchers believe that inflammation in the ear and brain may cause or worsen the phantom sounds. One hundred adults with tinnitus will receive either the supplement or a placebo for a period, and their symptoms will be tracked using questionnaires and hearing tests.

What this could mean

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

Active substance
umPEALUT (palmitoylethanolamide and luteolin) with or without rutin and 5-HTP
What this could lead to
If it works, this could point toward a new way to ease tinnitus by targeting inflammation in the brain and ear.
What could go wrong
This is an early, small trial with no phase designation. The supplement is not a proven treatment, and results may not apply to all tinnitus patients.

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 100 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Dec 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 to 70 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: \- Patients with tinnitus not under treatment at least for 30 days Exclusion Criteria: * Stroke in the last year * Uncontrolled diabetes, * Uncontrolled hypertension, * Severe psychiatric disorders, * Severe cognitive decline, * Previous surgery of the brain or audio-vestibular nerves

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Conditions

The condition(s) this trial relates to.

Neuroinflammatory Diseases neuronitis tinnitus

As listed by the trial registrant

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

Neuroinflammation Tinnitus

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

  • Vanvitelli ENT department

    Naples, Campania, 80138, Italy

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