Neuropathic Pain ManagementNCT07377409
Beneficial Effects of Supplementation With CRONILIEF™ (Palmitoylethanolamide Phospholipids) in Diabetic Subjects With Neuropathic Pain.
A study testing Cronilief™ (300 mg) in people with Neuropathic Pain Management and Diabetic Neuropathies, Painful, run by Azienda di Servizi alla Persona di Pavia.
Trial summary
This study aims to evaluate the potential benefit of an oral nutritional supplement based on CRONILIEF™ (Palmitoylethanolamide Phospholipids) in diabetic subjects with neuropathic pain, compared to a placebo. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neuropathic Pain Management, Diabetic Neuropathies, Painful, Palmitoylethanolamide
- What is being tested?
- Cronilief™ (300 mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2026to 15 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
About this study
Official title: Randomised, Placebo-controlled Study to Evaluate the Beneficial Effects of Supplementation With CRONILIEF™ (Palmitoylethanolamide Phospholipids), in Addition to Standard Therapy, in Diabetic Subjects With Neuropathic Pain.
This study aims to evaluate the potential benefit of an oral nutritional supplement based on CRONILIEF™ (Palmitoylethanolamide Phospholipids) in diabetic subjects with neuropathic pain, compared to a placebo.
- Being tested
- Cronilief™ (300 mg), Placebo
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cronilief™ (300 mg)Dietary supplement
- Week 1: Cronilief™ (300 mg), 2 tablets per day, single administration
- Weeks 2-8: Cronilief™ (300 mg), 1 tablet per day
PlaceboDietary supplement
- Week 1: Placebo, 2 tablets per day, single administration
- Weeks 2-8: Placebo, 1 tablet per day.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Cronilief™ supplementation | Experimental | Cronilief™ (300 mg) supplementation Receives: Dietary Supplement: Cronilief™ (300 mg) |
| Group B: Placebo | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate specific symptoms of neuropathic pain in diabetic subjects
Evaluate the effectiveness of Cronilief™ supplementation versus placebo, in combination with standard therapy, in improving specific symptoms of neuropathic pain in diabetic subjects after 8 weeks of supplementation, using the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) questionnaire as an assessment tool.
The LANSS score ranges from 0 to 24, with higher scores indicating a greater neuropathic pain component (worse outcome). A score ≥12 is indicative of neuropathic pain.
Measured: Baseline (T0), 4 week (T1), 8 week (T2) and one month after the end of integration
Secondary outcomes (3)
Evaluate sleep quality
Assess the impact of Cronilief™ supplementation on sleep quality, measured using the Pittsburgh Sleep Quality Index (PSQI). The PSQI total score ranges from 0 to 21, with higher scores indicating worse sleep quality (poorer outcome). A total score >5 is indicative of poor sleep quality.
Measured: Baseline (T0), 4 week (T1), 8 week (T2) and one month after the end of integration
Evaluate emotional states
Assess the impact of Cronilief™ supplementation on emotional states related to stress, anxiety and depression through the administration of the Depression Anxiety Stress Scales (DASS-21).
The DASS-21 consists of three subscales (Depression, Anxiety, Stress), each ranging from 0 to 21. Higher scores indicate greater severity of symptoms (worse outcome).
Measured: Baseline (T0), 4 week (T1), 8 week (T2) and one month after the end of integration
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Assess the safety of Cronilief™ by monitoring AEs (Adverse Events) and SAEs (Serious Adverse Events) evaluated by investigators and reported in accordance with current regulations.
Measured: Baseline (T0), 4 week (T1), 8 week (T2) and one month after the end of integration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start15 Sep 2026 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic Pain ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda di Servizi alla Persona di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07377409
- Sponsor's protocol ID
- 1812/28082025
- Status last verified
- Jan 2026
- First submitted
- 22 Jan 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Placebo-controlled Study to Evaluate the Beneficial Effects of Supplementation With CRONILIEF™ (Palmitoylethanolamide Phospholipids), in Addition to Standard Therapy, in Diabetic Subjects With Neuropathic Pain.
- ClinicalTrials.gov ID
- NCT07377409
- Acronym / sponsor ID
- 1812/28082025
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Azienda di Servizi alla Persona di PaviaUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the potential benefit of an oral nutritional supplement based on CRONILIEF™ (Palmitoylethanolamide Phospholipids) in diabetic subjects with neuropathic pain, compared to a placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Cronilief™ supplementation | Experimental | Dietary Supplement: Cronilief™ (300 mg)Cronilief™ (300 mg) supplementation |
| Group B: Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cronilief™ (300 mg)* Week 1: Cronilief™ (300 mg), 2 tablets per day, single administration * Weeks 2-8: Cronilief™ (300 mg), 1 tablet per day | Dietary supplement | Group A: Cronilief™ supplementation |
| Placebo* Week 1: Placebo, 2 tablets per day, single administration * Weeks 2-8: Placebo, 1 tablet per day. | Dietary supplement | Group B: Placebo |
Primary outcome
Evaluate specific symptoms of neuropathic pain in diabetic subjects
Time frame: Baseline (T0), 4 week (T1), 8 week (T2) and one month after the end of integration
Evaluate the effectiveness of Cronilief™ supplementation versus placebo, in combination with standard therapy, in improving specific symptoms of neuropathic pain in diabetic subjects after 8 weeks of supplementation, using the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) questionnaire as an assessment tool. The LANSS score ranges from 0 to 24, with higher scores indicating a greater neuropathic pain component (worse outcome). A score ≥12 is indicative of neuropathic pain.
3 secondary outcomes
Evaluate sleep quality
Time frame: Baseline (T0), 4 week (T1), 8 week (T2) and one month after the end of integration
Evaluate emotional states
Time frame: Baseline (T0), 4 week (T1), 8 week (T2) and one month after the end of integration
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Baseline (T0), 4 week (T1), 8 week (T2) and one month after the end of integration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Cronilief™ (300 mg) in people with Neuropathic Pain Management and Diabetic Neuropathies, Painful, run by Azienda di Servizi alla Persona di Pavia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate specific symptoms of neuropathic pain in diabetic subjects (time frame: Baseline (T0), 4 week (T1), 8 week (T2) and one month after the end of integration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.