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Can a natural supplement soothe diabetic nerve pain?

NCT ID NCT07377409

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a dietary supplement called Cronilief (palmitoylethanolamide) can reduce nerve pain in people with diabetes when added to their usual treatment. Seventy adults with moderate nerve pain will take either the supplement or a placebo for 8 weeks. The goal is to see if it improves pain and sleep quality.

What this could mean

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

Active substance
Cronilief (palmitoylethanolamide phospholipids)
What this could lead to
If it works, this could offer a natural supplement option to help manage nerve pain in people with diabetes.
What could go wrong
This is a small, early-stage trial with only 70 people. The supplement may not work better than placebo, and results may not apply to everyone with diabetic nerve pain.

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 70 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jan 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 to 65 years

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: * Satisfactory metabolic compensation; * Presence of moderate symptoms of painful diabetic neuropathy as assessed by the LANSS questionnaire (score ≥12); * Taking antidiabetic drugs except insulin; * Subjects willing and able to comply with scheduled study visits, the treatment plan, and all procedures outlined in the study. Exclusion Criteria: * Previous intolerance to a component of the nutraceuticals tested; * Individuals with type I diabetes; * Uncontrolled diabetes, severe cardiovascular and cerebrovascular diseases; * Severe neuropathic symptoms as indicated by the LANSS score; * Individuals undergoing insulin treatment; * Peripheral neuropathy due to diseases other than diabetes mellitus; * History of malignant neoplasm in the 5 years prior to enrolment in the study; * Serious neurological, psychological or psychiatric disorders; * Clinical signs or history of significant impairment of hepatic or renal function, peptic ulcer or coagulation disorders; * Any clinically relevant or unstable disease (e.g., active malignancies, immune system disorders) whose sequelae or treatments could contraindicate participation in the study or interfere with the study's evaluation parameters, in the investigator's judgement; Any disease that could significantly affect the study's outcome, including, but not limited to, chronic medical conditions, psychological disorders, or substance abuse; * Alcohol or drug abuse; * Women of childbearing age who do not use established contraceptive methods; * Pregnancy and breastfeeding.

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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

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  1. The official record

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