TinnitusTiniPEANCT06718452
Tinnitus and Treatment With umPEA-LUT
A study testing PEA-LUT 2 sachet day and umPEALUT + Rutin + 5 hTp in people with Tinnitus and Neuroinflammation, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial summary
Tinnitus can have different causes. From a peripheral point of view, the sensation of hearing a not present sound can be indicative of damage in the cells of the cochlea. Damage at this level can arise from traumatic, vascular, toxic origins or be caused by systemic pathologies. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Tinnitus, Neuroinflammation
- What is being tested?
- PEA-LUT 2 sachet day and umPEALUT + Rutin + 5 hTp
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 20 Apr 2026to 31 Dec 2026
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with tinnitus not under treatment at least for 30 days
Who cannot join
- Stroke in the last year
- Uncontrolled diabetes,
- Uncontrolled hypertension,
- Severe psychiatric disorders,
- Severe cognitive decline,
- Previous surgery of the brain or audio-vestibular nerves
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Vanvitelli ENT department
Naples, Campania, 80138
Giovanni Motta, MD, 081 566 6432, giovannimotta95@yahoo.it
About this study
Official title: Treatment of Tinnitus Targeting Neuroinflammation. umPEALUT as Possible Option
Tinnitus can have different causes. From a peripheral point of view, the sensation of hearing a not present sound can be indicative of damage in the cells of the cochlea. Damage at this level can arise from traumatic, vascular, toxic origins or be caused by systemic pathologies. However, all the previous causes have a common denominator, the presence of reactive oxygen species (ROS), in the cochlea which determines the damage and the consequent death of the hair cells into the ear. The sound (tinnitus) that the patient perceives is generated by the spontaneous movement of the cilia of the hair cells; this phenomenon arises when these cells begin to be damaged.
Tinnitus can be also caused by a retrocochlear disorder such as damage of the auditory nerve (inflammatory and tumor cause). In case of an inflammatory origin, the factors released during inflammation can locally damage the nerves and spread into the cochlea destroying the hair cells.
Read more
Tinnitus can also originate from damage in the central auditory pathway. In this case, the problem persistent. It is important to keep in mind that although initially the tinnitus may originate from a damage inside the cochlea, after 6 months of persistence chronicizes causing an activation (without stimulus) of the upper auditory areas. This zone of "hypersensitivity" is therefore responsible for chronic tinnitus.
In addition to the overmentioned medical causes, tinnitus can also be sign of psychiatric/psychological disorders, in those cases in whom there is an involvement of the hypothalamus, as showed by neuropsychological studies. Tinnitus can be temporary and disappear spontaneously or, in the most of cases, be persistent and extremely annoying/stressful for the patient. At night in particular, in the absence of noise, the patient suffers more the presence of this ghost sound, which in some occasions prevents sleep. Insomnia negatively impacts on tinnitus increasing its duration and intensity, thus establishing a perpetual cycle of stress into the brain. The latter phenomenon worses and chronicizes the symptom .
Stress causes inflammation with ROS increase, which can affect both the peripheral and central auditory pathways. Recently, it has been shown that tinnitus can be a symptom of neuro-inflammatory pathologies such as, for example, Multiple Sclerosis.
The effects of inflammation on the hair cells are identifiable only through electrophysiological studies or from the temporal bone.
Keeping on mind inflammation and neuro-inflammation and considering the exchange between cerebrospinal fluid and perilymph , we speculate that the use of a molecule capable of reducing inflammation and modulating the action of mast cells and microglia, could be an effective tool to resolve tinnitus; moreover, thanks to its powerful action at the level of neuro-inflammation, it could reduce the hyper-activity in the upper auditory tracts, thus reducing/abolishing noise.
umPeaLut combines palmitoylethanolamide, which modulates the activity of mast cells, macrophages and microglia and luteolin, a bioflanoid extracted from fruits with anti-oxidant properties, able to improve microcirculation. Because the alterations of the ear microcirculation can be an additional cause of tinnitus, we believe that luteolin content can be an ulterior benefit.
Although various attempts have been made to use a mono-molecule, recent studies have shown that combination of several elements could reduce tinnitus ; PeaLut, in its ultra-micronized form with high bioavailability, could be the perfect solution.
This study aims at evaluating the efficacy of umPEALUT as a therapeutic treatment of tinnitus in a sample of adults.
Read the detailed description
Longitudinal study on 100 patients
Patients between 18 and 70 years of age, not affected by systemic disorders (hypertension, diabetes, neurological disorders, previous stroke) or known psychological/psychiatric disorders will be included.
The patients will be evaluated at three observation times: T0 before treatment at the time of enrollment, T3 after 3 months and T6 after six months of treatment.
All patients, at each check-point will be screened as following: 1) three questionnaire to evaluate Tinnitus and 2) audiometric examination and acuphenometry.
Patients will be randomized into three groups, one group (CONTROL) that will use placebo, one (TREATMENT1 ) group that will use umPEALUT 2 sachets for day, and the other group (TREATMENT 2) umPEALUT 2 sachets par day combined to 120 mg of Rutin and 100 of 5-hTP.
EXPECTED RESULTS
Patients treated with umPEALUT compared to the control group will present an improvement of the symptom due to the anti-ROS action of luteolin and the neuro-immuno-modulating action of PEA. However the combination of umPEALUt with rutin and 5hTp will have better results than treatment with umPEALUT alone and control.
The changes induced by the treatment will be identifiable through the improvement of the symptom (responses to the questionnaire) and the changes in the subjective auditory test.
Specifically, patients in group 1 will present better final values than group 2, although group 2 will, however, present improvements compared to the control.
- Conditions
- Tinnitus, Neuroinflammation
- Being tested
- PEA-LUT 2 sachet day, Placebo, umPEALUT + Rutin + 5 hTp
- Keywords
- Tinnitus, Neuroinflammation, Palmitoyetanolamide, Luteolin, Ultramicronized, Vascular, Central, Peripheral, Auditory cortex, Inner ear
- Medical subject headings
- Tinnitus, Neuroinflammatory Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEA-LUT 2 sachet dayDietary supplement
1 sachet two times a day to be sublingually absorbed
PlaceboDietary supplement
Same administration of PEA-LUT
umPEALUT + Rutin + 5 hTpCombination product
People in this group will be treated by 2 sachets par day of umPEALUT associated to 120 mg of rutin and 100 mg of 5 hTp
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Patients in this group will be treated using placebo Receives: Dietary Supplement: Placebo |
| Ultramicronized PEALUT Double dose | Experimental | umPEALUT 2 sachet/day every day for 60 days Receives: Dietary Supplement: PEA-LUT 2 sachet day |
| TREATMENT 2 | Experimental | umPEALUT 2 sachets day + 120 mg Rutin +100 mg 5 hTp Receives: Combination Product: umPEALUT + Rutin + 5 hTp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tinnitus
Tinnitus questionnaire
Measured: At Enrollement, after 3 months of treatment, after 6 months of treatment (end of the therapy)
Secondary outcomes (1)
Auditory test
Pure Tone Auditory test
Measured: Enrollement (T0) and after 6 months (end of the therapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start20 Apr 2026 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for TinnitusStudies 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
- Model description
- Longitudinal study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Collaborators
- Federico II University
- Responsible party
- Principal investigator, Arianna Di Stadio, University of Campania Luigi Vanvitelli
- Investigators
- Arianna Di Stadio, MD, PhD, MSc, Study chair, Vanvitelli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06718452
- Sponsor's protocol ID
- UniLINK2026
- Other IDs
- University LINK
- Acronym
- TiniPEA
- Status last verified
- Feb 2026
- First submitted
- 28 Nov 2024
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We are thinking about put everything in a repository
Publications
Polanski JF, Soares AD, de Mendonca Cruz OL. Antioxidant therapy in the elderly with tinnitus. Braz J Otorhinolaryngol. 2016 May-Jun;82(3):269-74. doi: 10.1016/j.bjorl.2015.04.016. Epub 2015 Oct 17.
PubMed 26547700Petridou AI, Zagora ET, Petridis P, Korres GS, Gazouli M, Xenelis I, Kyrodimos E, Kontothanasi G, Kaliora AC. The Effect of Antioxidant Supplementation in Patients with Tinnitus and Normal Hearing or Hearing Loss: A Randomized, Double-Blind, Placebo Controlled Trial. Nutrients. 2019 Dec 12;11(12):3037. doi: 10.3390/nu11123037.
PubMed 31842394Wicinski M, Socha M, Walczak M, Wodkiewicz E, Malinowski B, Rewerski S, Gorski K, Pawlak-Osinska K. Beneficial Effects of Resveratrol Administration-Focus on Potential Biochemical Mechanisms in Cardiovascular Conditions. Nutrients. 2018 Nov 21;10(11):1813. doi: 10.3390/nu10111813.
PubMed 30469326Facchinetti R, Valenza M, Bronzuoli MR, Menegoni G, Ratano P, Steardo L, Campolongo P, Scuderi C. Looking for a Treatment for the Early Stage of Alzheimer's Disease: Preclinical Evidence with Co-Ultramicronized Palmitoylethanolamide and Luteolin. Int J Mol Sci. 2020 May 27;21(11):3802. doi: 10.3390/ijms21113802.
PubMed 32471239Di Stadio A, Ralli M. Inner ear involvement in multiple sclerosis: An underestimated condition? Mult Scler. 2018 Aug;24(9):1264-1265. doi: 10.1177/1352458517750010. No abstract available.
PubMed 30015600Albanese M, Di Girolamo S, Silvani L, Ciaschi E, Chiaramonte B, Conti M, Passali FM, Di Gioia B, Mercuri NB, Di Stadio A. Distortion Product Otoacoustic Emissions and Their Suppression as Predictors of Peripheral Auditory Damage in Migraine: A Case-Control Study. J Clin Med. 2021 Oct 27;10(21):5007. doi: 10.3390/jcm10215007.
PubMed 34768526Cronlein T, Langguth B, Geisler P, Hajak G. Tinnitus and insomnia. Prog Brain Res. 2007;166:227-33. doi: 10.1016/S0079-6123(07)66021-X.
PubMed 17956787Mazurek B, Szczepek AJ, Hebert S. Stress and tinnitus. HNO. 2015 Apr;63(4):258-65. doi: 10.1007/s00106-014-2973-7.
PubMed 25862619Xu Y, Shi Y, Yao J, Yang H, Ding Z, Chen QQ, Liu Y, Chen W. Altered brain functional connectivity and correlation with psychological status in patients with unilateral pulsatile tinnitus. Neurosci Lett. 2019 Jul 13;705:235-245. doi: 10.1016/j.neulet.2019.04.046. Epub 2019 Apr 28.
PubMed 31042571Andersson G. Psychological aspects of tinnitus and the application of cognitive-behavioral therapy. Clin Psychol Rev. 2002 Sep;22(7):977-90. doi: 10.1016/s0272-7358(01)00124-6.
PubMed 12238249Shulman A, Wang W, Luo H, Bao S, Searchfield G, Zhang J. Neuroinflammation and Tinnitus. Curr Top Behav Neurosci. 2021;51:161-174. doi: 10.1007/7854_2021_238.
PubMed 34282564Galazyuk AV, Wenstrup JJ, Hamid MA. Tinnitus and underlying brain mechanisms. Curr Opin Otolaryngol Head Neck Surg. 2012 Oct;20(5):409-15. doi: 10.1097/MOO.0b013e3283577b81.
PubMed 22931904Savastano M, Brescia G, Marioni G. Antioxidant therapy in idiopathic tinnitus: preliminary outcomes. Arch Med Res. 2007 May;38(4):456-9. doi: 10.1016/j.arcmed.2006.12.004. Epub 2007 Mar 12.
PubMed 17416295Naunton RF, Proctor L, Elpern BS. The audiologic signs of ninth nerve neurinoma. Arch Otolaryngol. 1968 Mar;87(3):222-7. doi: 10.1001/archotol.1968.00760060224002. No abstract available.
PubMed 5642369Di Stadio A, Dipietro L, Ralli M, Meneghello F, Minni A, Greco A, Stabile MR, Bernitsas E. Sudden hearing loss as an early detector of multiple sclerosis: a systematic review. Eur Rev Med Pharmacol Sci. 2018 Jul;22(14):4611-4624. doi: 10.26355/eurrev_201807_15520.
PubMed 30058696
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Tinnitus Targeting Neuroinflammation. umPEALUT as Possible Option
- ClinicalTrials.gov ID
- NCT06718452
- Acronym / sponsor ID
- TiniPEA / UniLINK2026
- Conditions
- Tinnitus, Neuroinflammation
- Keywords
- Tinnitus, Neuroinflammation, Palmitoyetanolamide, Luteolin, Ultramicronized, Vascular, Central, Peripheral
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Collaborators
- Federico II University
- Study start
- 20 Apr 2026 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Dec 2024 (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.
Tinnitus can have different causes. From a peripheral point of view, the sensation of hearing a not present sound can be indicative of damage in the cells of the cochlea. Damage at this level can arise from traumatic, vascular, toxic origins or be caused by systemic pathologies. However, all the previous causes have a common denominator, the presence of reactive oxygen species (ROS), in the cochlea which determines the damage and the consequent death of the hair cells into the ear. The sound (tinnitus) that the patient perceives is generated by the spontaneous movement of the cilia of the hair cells; this phenomenon arises when these cells begin to be damaged.
Tinnitus can be also caused by a retrocochlear disorder such as damage of the auditory nerve (inflammatory and tumor cause). In case of an inflammatory origin, the factors released during inflammation can locally damage the nerves and spread into the cochlea destroying the hair cells.
Tinnitus can also originate from damage in the central auditory pathway. In this case, the problem persistent. It is important to keep in mind that although initially the tinnitus may originate from a damage inside the cochlea, after 6 months of persistence chronicizes causing an activation (without stimulus) of the upper auditory areas. This zone of "hypersensitivity" is therefore responsible for chronic tinnitus.
In addition to the overmentioned medical causes, tinnitus can also be sign of psychiatric/psychological disorders, in those cases in whom there is an involvement of the hypothalamus, as showed by neuropsychological studies. Tinnitus can be temporary and disappear spontaneously or, in the most of cases, be persistent and extremely annoying/stressful for the patient. At night in particular, in the absence of noise, the patient suffers more the presence of this ghost sound, which in some occasions prevents sleep. Insomnia negatively impacts on tinnitus increasing its duration and intensity, thus establishing a perpetual cycle of stress into the brain. The latter phenomenon worses and chronicizes the symptom .
Stress causes inflammation with ROS increase, which can affect both the peripheral and central auditory pathways. Recently, it has been shown that tinnitus can be a symptom of neuro-inflammatory pathologies such as, for example, Multiple Sclerosis.
The effects of inflammation on the hair cells are identifiable only through electrophysiological studies or from the temporal bone.
Keeping on mind inflammation and neuro-inflammation and considering the exchange between cerebrospinal fluid and perilymph , we speculate that the use of a molecule capable of reducing inflammation and modulating the action of mast cells and microglia, could be an effective tool to resolve tinnitus; moreover, thanks to its powerful action at the level of neuro-inflammation, it could reduce the hyper-activity in the upper auditory tracts, thus reducing/abolishing noise.
umPeaLut combines palmitoylethanolamide, which modulates the activity of mast cells, macrophages and microglia and luteolin, a bioflanoid extracted from fruits with anti-oxidant properties, able to improve microcirculation. Because the alterations of the ear microcirculation can be an additional cause of tinnitus, we believe that luteolin content can be an ulterior benefit.
Although various attempts have been made to use a mono-molecule, recent studies have shown that combination of several elements could reduce tinnitus ; PeaLut, in its ultra-micronized form with high bioavailability, could be the perfect solution.
This study aims at evaluating the efficacy of umPEALUT as a therapeutic treatment of tinnitus in a sample of adults.
Detailed description
Longitudinal study on 100 patients
Patients between 18 and 70 years of age, not affected by systemic disorders (hypertension, diabetes, neurological disorders, previous stroke) or known psychological/psychiatric disorders will be included.
The patients will be evaluated at three observation times: T0 before treatment at the time of enrollment, T3 after 3 months and T6 after six months of treatment.
All patients, at each check-point will be screened as following: 1) three questionnaire to evaluate Tinnitus and 2) audiometric examination and acuphenometry.
Patients will be randomized into three groups, one group (CONTROL) that will use placebo, one (TREATMENT1 ) group that will use umPEALUT 2 sachets for day, and the other group (TREATMENT 2) umPEALUT 2 sachets par day combined to 120 mg of Rutin and 100 of 5-hTP.
EXPECTED RESULTS
Patients treated with umPEALUT compared to the control group will present an improvement of the symptom due to the anti-ROS action of luteolin and the neuro-immuno-modulating action of PEA. However the combination of umPEALUt with rutin and 5hTp will have better results than treatment with umPEALUT alone and control.
The changes induced by the treatment will be identifiable through the improvement of the symptom (responses to the questionnaire) and the changes in the subjective auditory test.
Specifically, patients in group 1 will present better final values than group 2, although group 2 will, however, present improvements compared to the control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Longitudinal study
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPatients in this group will be treated using placebo |
| Ultramicronized PEALUT Double dose | Experimental | Dietary Supplement: PEA-LUT 2 sachet dayumPEALUT 2 sachet/day every day for 60 days |
| TREATMENT 2 | Experimental | Combination Product: umPEALUT + Rutin + 5 hTpumPEALUT 2 sachets day + 120 mg Rutin +100 mg 5 hTp |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with tinnitus not under treatment at least for 30 days
Key exclusion criteria (6 listed)
- Stroke in the last year
- Uncontrolled diabetes,
- Uncontrolled hypertension,
- Severe psychiatric disorders,
- Severe cognitive decline,
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 |
|---|---|---|
| PEA-LUT 2 sachet day1 sachet two times a day to be sublingually absorbed | Dietary supplement | Ultramicronized PEALUT Double dose |
| PlaceboSame administration of PEA-LUT | Dietary supplement | Placebo |
| umPEALUT + Rutin + 5 hTpPeople in this group will be treated by 2 sachets par day of umPEALUT associated to 120 mg of rutin and 100 mg of 5 hTp | Combination product | TREATMENT 2 |
Primary outcome
Tinnitus
Time frame: At Enrollement, after 3 months of treatment, after 6 months of treatment (end of the therapy)
Tinnitus questionnaire
1 secondary outcome
Auditory test
Time frame: Enrollement (T0) and after 6 months (end of the therapy)
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 6 Feb 2026.
- Results publication: PubMed 26547700Polanski JF, Soares AD, de Mendonca Cruz OL. Antioxidant therapy in the elderly with tinnitus. Braz J Otorhinolaryngol. 2016 May-Jun;82(3):269-74. doi: 10.1016/j.bjorl.2015.04.016. Epub 2015 Oct 17.
- Results publication: PubMed 31842394Petridou AI, Zagora ET, Petridis P, Korres GS, Gazouli M, Xenelis I, Kyrodimos E, Kontothanasi G, Kaliora AC. The Effect of Antioxidant Supplementation in Patients with Tinnitus and Normal Hearing or Hearing Loss: A Randomized, Double-Blind, Placebo Controlled Trial. Nutrients. 2019 Dec 12;11(12):3037. doi: 10.3390/nu11123037.
- Results publication: PubMed 30469326Wicinski M, Socha M, Walczak M, Wodkiewicz E, Malinowski B, Rewerski S, Gorski K, Pawlak-Osinska K. Beneficial Effects of Resveratrol Administration-Focus on Potential Biochemical Mechanisms in Cardiovascular Conditions. Nutrients. 2018 Nov 21;10(11):1813. doi: 10.3390/nu10111813.
- Results publication: PubMed 32471239Facchinetti R, Valenza M, Bronzuoli MR, Menegoni G, Ratano P, Steardo L, Campolongo P, Scuderi C. Looking for a Treatment for the Early Stage of Alzheimer's Disease: Preclinical Evidence with Co-Ultramicronized Palmitoylethanolamide and Luteolin. Int J Mol Sci. 2020 May 27;21(11):3802. doi: 10.3390/ijms21113802.
- Results publication: PubMed 30015600Di Stadio A, Ralli M. Inner ear involvement in multiple sclerosis: An underestimated condition? Mult Scler. 2018 Aug;24(9):1264-1265. doi: 10.1177/1352458517750010. No abstract available.
- Results publication: PubMed 34768526Albanese M, Di Girolamo S, Silvani L, Ciaschi E, Chiaramonte B, Conti M, Passali FM, Di Gioia B, Mercuri NB, Di Stadio A. Distortion Product Otoacoustic Emissions and Their Suppression as Predictors of Peripheral Auditory Damage in Migraine: A Case-Control Study. J Clin Med. 2021 Oct 27;10(21):5007. doi: 10.3390/jcm10215007.
- Results publication: PubMed 17956787Cronlein T, Langguth B, Geisler P, Hajak G. Tinnitus and insomnia. Prog Brain Res. 2007;166:227-33. doi: 10.1016/S0079-6123(07)66021-X.
- Results publication: PubMed 25862619Mazurek B, Szczepek AJ, Hebert S. Stress and tinnitus. HNO. 2015 Apr;63(4):258-65. doi: 10.1007/s00106-014-2973-7.
- Results publication: PubMed 31042571Xu Y, Shi Y, Yao J, Yang H, Ding Z, Chen QQ, Liu Y, Chen W. Altered brain functional connectivity and correlation with psychological status in patients with unilateral pulsatile tinnitus. Neurosci Lett. 2019 Jul 13;705:235-245. doi: 10.1016/j.neulet.2019.04.046. Epub 2019 Apr 28.
- Results publication: PubMed 12238249Andersson G. Psychological aspects of tinnitus and the application of cognitive-behavioral therapy. Clin Psychol Rev. 2002 Sep;22(7):977-90. doi: 10.1016/s0272-7358(01)00124-6.
- Results publication: PubMed 34282564Shulman A, Wang W, Luo H, Bao S, Searchfield G, Zhang J. Neuroinflammation and Tinnitus. Curr Top Behav Neurosci. 2021;51:161-174. doi: 10.1007/7854_2021_238.
- Results publication: PubMed 22931904Galazyuk AV, Wenstrup JJ, Hamid MA. Tinnitus and underlying brain mechanisms. Curr Opin Otolaryngol Head Neck Surg. 2012 Oct;20(5):409-15. doi: 10.1097/MOO.0b013e3283577b81.
- Individual participant dataSharing planned: Undecided. We are thinking about put everything in a repository
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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.
Arianna Di Stadio, MD, PhD, MSc study chair
Vanvitelli University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEA-LUT 2 sachet day and umPEALUT + Rutin + 5 hTp in people with Tinnitus and Neuroinflammation, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
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 1 inclusion and 6 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 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tinnitus (time frame: At Enrollement, after 3 months of treatment, after 6 months of treatment (end of the therapy)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06718452, which also lists 22 linked publications.
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 6 Feb 2026.