Tinnitus, SubjectivePhase 2NCT05646693
Effect of Combined Antioxidant Therapy on Oxidative Stress Markers and Inflammatory Cytokines in Patients With Tinnitus
A Phase 2 study testing Drusen Mega® and Sertraline in people with Tinnitus, Subjective and Tinnitus, Bilateral, run by University of Guadalajara at 1 site in Mexico.
Trial summary
The main objective of our study is to evaluate the effect of combinated antioxidants therapy with Adepsique® (amitriptyline, perphenazine, and diazepam) on patients with tinnitus chronic symptoms, evaluating the levels of inflammatory cytokines and oxidative stress in blood. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Tinnitus, Subjective, Tinnitus, Bilateral, Antioxidant Therapy
- What is being tested?
- Drusen Mega® and Sertraline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteMexico
- Study dates
- 1 Dec 2022to 31 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female with subjective chronic tinnitus (unilateral or bilateral)
- Patients with normal audiometry or identification of hearing loss up to a medium degree (20-70 dB)
- Patients with evidence of endotic tinnitus
- Patients who have or do not have social medical security
- Females of childbearing age with a negative pregnancy test and use of oral contraceptives
- Patients under pharmacological management with a period of stable medication (≥3 months) for chronic degenerative diseases and under good metabolic control (according to ADA 2022 criteria) through primary intervention
Who cannot join
- Presence of tinnitus secondary to head trauma, acoustic trauma, or sudden hearing loss
- History or presence of Ménière's disease, otosclerosis, acute or chronic otitis media
- Active gastrointestinal haemorrhagic disease
- History or presence of cancer (any type) or submission to radio and/or chemotherapy
- Autoimmune disease (any)
- History of severe cardiovascular disease (myocardial infarction, stroke, severe peripheral vascular disease)
Show all 21Show fewer
- Benign prostatic hyperplasia
- Blood dyscrasias and/or bleeding diathesis
- Thyroid disease (any)
- Temporomandibular joint dysfunction
- Neurodegenerative processes
- Hepatic and renal failure
- Closed or open angle glaucoma
- Intake of any medication belonging to the following families (Anticoagulants, Benzodiazepines, ASA diuretics, Aminoglycosides, Chemotherapeutics, Acetylsalicylic Acid, Quinine, MAOIs)
- Intake of antioxidants in the last 6 months
- Hypersensitivity to vitamins that constitute the antioxidant intervention, or any medication belonging to the Adepsique formulation
- Pregnancy, lactation
- History of disease due to COVID-19 infection in the last 6 months
- Diet rich in antioxidants that exceeds the concentrations of the daily nutritional recommendations of the Dietary Reference Intake
- Participation in another clinical trial
- Drug abuse, smoking (daily consumption during the last month of 5 to 10 cigarettes) and/or alcoholism
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Institute of Experimental and Clinical Therapeutics,
Guadalajara, Jalisco, 44340
Adolfo D. Rodriguez-Carrizalez, PhD, +52 33 10585200 ext. 33658, adolfo.rodriguez@academicos.udg.mx
Uriel A. Ibarra-Díaz, MD, +52 33 14654244, uriel.ibarra1323@alumnos.udg.mx
About this study
Official title: Effect of Combined Antioxidant Therapy on Oxidative Stress Markers and Inflammatory in Patients With Chronic Subjective Endotic Tinnitus
The main objective of our study is to evaluate the effect of combinated antioxidants therapy with Adepsique® (amitriptyline, perphenazine, and diazepam) on patients with tinnitus chronic symptoms, evaluating the levels of inflammatory cytokines and oxidative stress in blood.
The researchers intend to include 58 patients, divided into two intervention groups, who will be randomly assigned a pill with antioxidants or placebo, and the patient must eat one pill per day for 3 months.
In the study, the clinical characteristics of tinnitus, inflammatory cytokines and oxidative stress markers will be evaluated, before, during and after the intervention with antioxidant therapy. Subsequently, the clinical and sample results will be evaluated to compare the effects between them.
Read the detailed description
Tinnitus is a pathology defined as the perception of a sound without an external acoustic stimulus. About 15 to 20% of the world population suffers from this pathology.It is classified according to the time of presentation (acute or chronic); in the existence of an internal source measurable and perceptible by the patient and the physician (objective) or where the source does not exist and is only perceived by the patient (subjective), the latter being the most common. And, in the place where they originate, exotic (outside the ear), endotic (within the auditory apparatus), and central (within the cerebral cortex without lesion of the auditory apparatus). As well as the influence it presents in daily life, being mild, moderate, severe or catastrophic.
Within the pathophysiology, the influence of different proinflammatory cytokines such as IL-6, TNF-α, β-2GP1, IL-1, among others, is described; as well as markers of oxidative stress and elevated levels of ROS, which annul defense mechanisms against oxidative damage, and induce damage to DNA, lipids, and membrane proteins.ncreased levels of nitric oxide, peroxynitrite, nuclear transcriptional factor Kappa-B (NF-κB), glutamate (N-methyl D-aspartate) receptors, and calcium cause hair cell damage. On the other hand, reduced levels of antioxidant enzymes such as superoxide dismutase, glutathione peroxidase, glutathione reductase, catalase, and glutathione transferase perpetuate cell damage.
The diagnosis is based mainly on ruling out etiological factors, associated symptoms or existing comorbidities that cause tinnitus secondarily, as well as a detailed clinical history, measurement of hearing quality, and demonstration of the imbalance of neurotransmitters and proinflammatory molecules.
Because it is a multifactorial entity, the definitive treatment has not yet been developed. Extensive pharmacological therapies, from the use of NSAIDs to antidepressant and antipsychotic drugs, have been tried with ambiguous, inconsistent and inconclusive results. Alternative therapies with multivitamins and antioxidants have shown probable utility in the treatment of tinnitus, however, the existing evidence is of poor and conflicting quality.The latter reduce oxidative stress through different means; through the destruction of free radicals by donating electrons to the unpaired states of these radicals. Another means is through the catalysis of free radicals, converting them into harmless molecules (water and oxygen). Lastly, they support reducing chronic inflammation secondarily by decreasing the rate of auditory hairy cell apoptosis.
- Conditions
- Tinnitus, Subjective, Tinnitus, Bilateral, Antioxidant Therapy, Psychiatric Drugs, Oxidative Stress, Inflammatory Cytokines
- Being tested
- Drusen Mega®, Sertraline, Placebo
- Keywords
- Tinnitus
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drusen Mega®Dietary supplement
Also called Multivitamins
It consists of a dietary supplement composed of Vitamin C 60.0mg, Vitamin E 30.0mg, Zinc 12.5mg, Copper 1.0mg, Astaxanthin 4.0mg, Zeaxanthin 2.0mg, Lutein 10.0mg and Omega 3 Acids 500.0mg. It is suggested to consume one capsule per day, preferably with food. This supplement is indicated for nutritional deficiencies and in patients with ophthalmological pathologies.
SertralineDrug
Also called Sertraline Hydrochloride
It consists of a drug capsule composed of Sertraline Hydrochloride 50mg. In adults it is suggested to consume one to four capsule(s) per day, administering (preferably) the highest dose in the evening, before going to bed. This drug is indicated in the treatment of depressive states with anxiety or moderate to severe agitation, which are accompanied by tension, excitement, insomnia, obsessive and hypochondriac traits. It is also indicated in obsessive-compulsive disorder, panic attacks, stress disorder, post-traumatic disorder, social anxiety disorder and used to relieve the symptoms of premenstrual dysphoric disorder.
PlaceboDrug
Also called Magnesium Oxide
It consists of a placebo capsule composed of Magnesium Oxide 100mg. This component is inert in the dose at which it will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Drusen Mega® + Sertraline | Experimental | It will consist of 29 patients with Chronic Subjetive Endotic Tinnitus. Patients will eat one capsule of antioxidant therapy (Drusen Mega®) and one capsule of sertraline per day in the night for 3 months. Receives: Dietary Supplement: Drusen Mega®; Drug: Sertraline |
| Placebo + Sertraline | Placebo comparator | It will consist of 29 patients with Chronic Subjetive Endotic Tinnitus. Patients will eat one capsule of placebo (Magnesium Oxide 100mg) per day in the morning and one capsule of sertraline per day in the night for 3 months. Receives: Drug: Sertraline; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in levels of Superoxide Dismutase (SOD)
Standard blood sampling will be collected through a catheter in an antecubital vein in tubes without EDTA, centrifuged and serum will placed in an eppendorf tube at -80 celsius degrees. The enzyme concentration will be determined with multiplex bead immunoassays technique and reported in microunits per milliliter units (mUI/mL)
Measured: 90 days
Change from baseline in levels of Catalase (CAT)
Standard blood sampling will be collected through a catheter in an antecubital vein in tubes without EDTA, centrifuged and serum will placed in an eppendorf tube at -80 celsius degrees. The enzyme concentration will be determined with multiplex bead immunoassays technique and reported in microunits per milliliter units (mUI/mL)
Measured: 90 days
Change from baseline in levels of Glutathione Peroxidase (GPx)
Standard blood sampling will be collected through a catheter in an antecubital vein in tubes without EDTA, centrifuged and serum will placed in an eppendorf tube at -80 celsius degrees. The enzyme concentration will be determined with multiplex bead immunoassays technique and reported in microunits per milliliter units (mUI/mL)
Measured: 90 days
Change from baseline in levels of Malondialdehyde (MDA)
Standard blood sampling will be collected through a catheter in an antecubital vein in tubes without EDTA, centrifuged and serum will placed in an eppendorf tube at -80 celsius degrees. The enzyme concentration will be determined with multiplex bead immunoassays technique and reported in microunits per milliliter units (mUI/mL)
Measured: 90 days
Change from baseline in levels of Oxidized Low-Density Lipoprotein LDL (oxLDL)
Standard blood sampling will be collected through a catheter in an antecubital vein in tubes without EDTA, centrifuged and serum will placed in an eppendorf tube at -80 celsius degrees. The enzyme concentration will be determined with multiplex bead immunoassays technique and reported in nanograms per milliliter units (ng/mL)
Measured: 90 days
Change from baseline in levels of Tumor Necrosis Factor Alpha (TNF-a)
Standard blood sampling will be collected through a catheter in an antecubital vein in tubes without EDTA, centrifuged and serum will placed in an eppendorf tube at -80 celsius degrees. The cytokine concentration will be determined with multiplex bead immunoassays technique and reported in picogram per milliliter units (pg/mL)
Measured: 90 days
Change from baseline in levels of Interleukin 8 (IL-8)
Standard blood sampling will be collected through a catheter in an antecubital vein in tubes without EDTA, centrifuged and serum will placed in an eppendorf tube at -80 celsius degrees. The cytokine concentration will be determined with multiplex bead immunoassays technique and reported in picogram per milliliter units (pg/mL)
Measured: 90 days
Change from baseline in levels of Interleukin 6 (IL-6)
Standard blood sampling will be collected through a catheter in an antecubital vein in tubes without EDTA, centrifuged and serum will placed in an eppendorf tube at -80 celsius degrees. The cytokine concentration will be determined with multiplex bead immunoassays technique and reported in picogram per milliliter units (pg/mL)
Measured: 90 days
Change from baseline in levels of Gamma Interferon (IFN-γ)
Standard blood sampling will be collected through a catheter in an antecubital vein in tubes without EDTA, centrifuged and serum will placed in an eppendorf tube at -80 celsius degrees. The cytokine concentration will be determined with multiplex bead immunoassays technique and reported in picogram per milliliter units (pg/mL)
Measured: 90 days
Change from baseline in levels of Nuclear Factor Kappa B (NF-κB)
Standard blood sampling will be collected through a catheter in an antecubital vein in tubes without EDTA, centrifuged and serum will placed in an eppendorf tube at -80 celsius degrees. The cytokine concentration will be determined with multiplex bead immunoassays technique and reported in nanogram per milliliter units (ng/mL)
Measured: 90 days
Secondary outcomes (5)
Change from baseline in Tinnitus Loudness (db) Assessment
Tinnitus screening tests will be conducted, using psychoacoustic techniques including pitch loudness matching within a soundproof booth. Patients will be given pairs of different tones in the non-tinnitus or less intense ear and will be asked to choose which tone is closest to the perceived tinnitus. This will be continued until a definite match will made. The results will be expressed in decibels
Measured: 90 days
Change from baseline in Tinnitus Frecuency (Hz) Assessment
Tinnitus screening tests will be conducted, using psychoacoustic techniques including pitch frequency matching within a soundproof booth. Patients will be given pairs of different tones in the non-tinnitus or less intense ear and will be asked to choose which tone is closest to the perceived tinnitus. This will be continued until a definite match will made. The results will be expressed in hertz.
Measured: 90 days
Change from baseline in Audiometric Assessment
Patients will undergo conventional pure tone audiometry and extended high frequency (EHF) audiometry to determine any hearing loss. The degree of hearing loss will be determined using the average of values in four consecutive frequencies (500-1000-2000-4000) and will be classified as normal hearing, little, mild, moderate or severe hearing loss.
Measured: 90 days
Change from baseline in Tinnitus Discomfort Assessment
Patients will complete the questionnaire Tinnitus Handicap Inventory (THI) which measure the subjective discomfort a patient experiences because of tinnitus. THI comprises 25 questions which are divided in functional, emotional, and catastrophic subscales. Total scores of THI range from 0 to 100.
Measured: 90 days
Change from baseline in levels of Otolin-1
Otolin-1 is a scaffold glycoprotein that connects the otoliths and matrix proteins of the otoconial nucleus with the sensory epithelium. Under normal conditions it is not found in peripheral blood, but in some hearing diseases it can be measured due to the loss of the blood-cochlear barrier. This will serve as an ear-specific marker.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start1 Dec 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Tinnitus, SubjectiveStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clinical Trial Phase II A, controlled with placebo
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Experimental and Clinical Therapeutics, Hospital Civil de Guadalajara
- Responsible party
- Principal investigator, Adolfo Daniel Rodriguez-Carrizalez, University of Guadalajara
- Investigators
- Adolfo D Rodríguez-Carrizalez, MD / PhD, Principal investigator, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05646693
- Sponsor's protocol ID
- ACSE202208/IIA
- Status last verified
- Apr 2023
- First submitted
- 25 Nov 2022
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD is not planned to be shared. The data is protected under the Mexican Federal Law for the Protection of Personal Data Held by Private Parties.
Publications
Henry JA, Dennis KC, Schechter MA. General review of tinnitus: prevalence, mechanisms, effects, and management. J Speech Lang Hear Res. 2005 Oct;48(5):1204-35. doi: 10.1044/1092-4388(2005/084).
PubMed 16411806Weber C, Arck P, Mazurek B, Klapp BF. Impact of a relaxation training on psychometric and immunologic parameters in tinnitus sufferers. J Psychosom Res. 2002 Jan;52(1):29-33. doi: 10.1016/s0022-3999(01)00281-1.
PubMed 11801262Gomaa NA, Jimoh Z, Campbell S, Zenke JK, Szczepek AJ. Biomarkers for Inner Ear Disorders: Scoping Review on the Role of Biomarkers in Hearing and Balance Disorders. Diagnostics (Basel). 2020 Dec 29;11(1):42. doi: 10.3390/diagnostics11010042.
PubMed 33383894Solis-Angeles S, Juarez-Perez CA, Jimenez-Ramirez C, Cabello-Lopez A, Aguilar-Madrid G, Del Razo LM. Prestin and otolin-1 proteins in the hearing loss of adults chronically exposed to lead. Toxicol Appl Pharmacol. 2021 Sep 1;426:115651. doi: 10.1016/j.taap.2021.115651. Epub 2021 Jul 15.
PubMed 34273409Esmaili AA, Renton J. A review of tinnitus. Aust J Gen Pract. 2018 Apr;47(4):205-208. doi: 10.31128/AJGP-12-17-4420.
PubMed 29621860Celik M, Koyuncu I. A Comprehensive Study of Oxidative Stress in Tinnitus Patients. Indian J Otolaryngol Head Neck Surg. 2018 Dec;70(4):521-526. doi: 10.1007/s12070-018-1464-7. Epub 2018 Jul 27.
PubMed 30464909Polanski 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 26547700Pawlak-Osinska K, Kazmierczak H, Marzec M, Kupczyk D, Bilski R, Mikolajewska E, Mikolajewski D, Augustynska B. Assessment of the State of the Natural Antioxidant Barrier of a Body in Patients Complaining about the Presence of Tinnitus. Oxid Med Cell Longev. 2018 Oct 28;2018:1439575. doi: 10.1155/2018/1439575. eCollection 2018.
PubMed 30510615Petridou 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 31842394Baguley D, McFerran D, Hall D. Tinnitus. Lancet. 2013 Nov 9;382(9904):1600-7. doi: 10.1016/S0140-6736(13)60142-7. Epub 2013 Jul 2.
PubMed 23827090
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Combined Antioxidant Therapy on Oxidative Stress Markers and Inflammatory in Patients With Chronic Subjective Endotic Tinnitus
- ClinicalTrials.gov ID
- NCT05646693
- Acronym / sponsor ID
- ACSE202208/IIA
- Conditions
- Tinnitus, Subjective, Tinnitus, Bilateral, Antioxidant Therapy, Psychiatric Drugs, Oxidative Stress, Inflammatory Cytokines
- Keywords
- Tinnitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Collaborators
- Institute of Experimental and Clinical Therapeutics, Hospital Civil de Guadalajara
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 12 Dec 2022 (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.
The main objective of our study is to evaluate the effect of combinated antioxidants therapy with Adepsique® (amitriptyline, perphenazine, and diazepam) on patients with tinnitus chronic symptoms, evaluating the levels of inflammatory cytokines and oxidative stress in blood.
The researchers intend to include 58 patients, divided into two intervention groups, who will be randomly assigned a pill with antioxidants or placebo, and the patient must eat one pill per day for 3 months.
In the study, the clinical characteristics of tinnitus, inflammatory cytokines and oxidative stress markers will be evaluated, before, during and after the intervention with antioxidant therapy. Subsequently, the clinical and sample results will be evaluated to compare the effects between them.
Detailed description
Tinnitus is a pathology defined as the perception of a sound without an external acoustic stimulus. About 15 to 20% of the world population suffers from this pathology.It is classified according to the time of presentation (acute or chronic); in the existence of an internal source measurable and perceptible by the patient and the physician (objective) or where the source does not exist and is only perceived by the patient (subjective), the latter being the most common. And, in the place where they originate, exotic (outside the ear), endotic (within the auditory apparatus), and central (within the cerebral cortex without lesion of the auditory apparatus). As well as the influence it presents in daily life, being mild, moderate, severe or catastrophic.
Within the pathophysiology, the influence of different proinflammatory cytokines such as IL-6, TNF-α, β-2GP1, IL-1, among others, is described; as well as markers of oxidative stress and elevated levels of ROS, which annul defense mechanisms against oxidative damage, and induce damage to DNA, lipids, and membrane proteins.ncreased levels of nitric oxide, peroxynitrite, nuclear transcriptional factor Kappa-B (NF-κB), glutamate (N-methyl D-aspartate) receptors, and calcium cause hair cell damage. On the other hand, reduced levels of antioxidant enzymes such as superoxide dismutase, glutathione peroxidase, glutathione reductase, catalase, and glutathione transferase perpetuate cell damage.
The diagnosis is based mainly on ruling out etiological factors, associated symptoms or existing comorbidities that cause tinnitus secondarily, as well as a detailed clinical history, measurement of hearing quality, and demonstration of the imbalance of neurotransmitters and proinflammatory molecules.
Because it is a multifactorial entity, the definitive treatment has not yet been developed. Extensive pharmacological therapies, from the use of NSAIDs to antidepressant and antipsychotic drugs, have been tried with ambiguous, inconsistent and inconclusive results. Alternative therapies with multivitamins and antioxidants have shown probable utility in the treatment of tinnitus, however, the existing evidence is of poor and conflicting quality.The latter reduce oxidative stress through different means; through the destruction of free radicals by donating electrons to the unpaired states of these radicals. Another means is through the catalysis of free radicals, converting them into harmless molecules (water and oxygen). Lastly, they support reducing chronic inflammation secondarily by decreasing the rate of auditory hairy cell apoptosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Clinical Trial Phase II A, controlled with placebo
| Arm | Type | Receives |
|---|---|---|
| Drusen Mega® + Sertraline | Experimental | Dietary Supplement: Drusen Mega®, Drug: SertralineIt will consist of 29 patients with Chronic Subjetive Endotic Tinnitus. Patients will eat one capsule of antioxidant therapy (Drusen Mega®) and one capsule of sertraline per day in the night for 3 months. |
| Placebo + Sertraline | Placebo comparator | Drug: Sertraline, Drug: PlaceboIt will consist of 29 patients with Chronic Subjetive Endotic Tinnitus. Patients will eat one capsule of placebo (Magnesium Oxide 100mg) per day in the morning and one capsule of sertraline per day in the night for 3 months. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female with subjective chronic tinnitus (unilateral or bilateral)
- Patients with normal audiometry or identification of hearing loss up to a medium degree (20-70 dB)
- Patients with evidence of endotic tinnitus
- Patients who have or do not have social medical security
- Females of childbearing age with a negative pregnancy test and use of oral contraceptives
Key exclusion criteria (21 listed)
- Presence of tinnitus secondary to head trauma, acoustic trauma, or sudden hearing loss
- History or presence of Ménière's disease, otosclerosis, acute or chronic otitis media
- Active gastrointestinal haemorrhagic disease
- History or presence of cancer (any type) or submission to radio and/or chemotherapy
- Autoimmune disease (any)
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 |
|---|---|---|
| Drusen Mega®Also: MultivitaminsIt consists of a dietary supplement composed of Vitamin C 60.0mg, Vitamin E 30.0mg, Zinc 12.5mg, Copper 1.0mg, Astaxanthin 4.0mg, Zeaxanthin 2.0mg, Lutein 10.0mg and Omega 3 Acids 500.0mg. It is suggested to consume one capsule per day, preferably with food. This supplement is indicated for nutritional deficiencies and in patients with ophthalmological pathologies. | Dietary supplement | Drusen Mega® + Sertraline |
| SertralineAlso: Sertraline HydrochlorideIt consists of a drug capsule composed of Sertraline Hydrochloride 50mg. In adults it is suggested to consume one to four capsule(s) per day, administering (preferably) the highest dose in the evening, before going to bed. This drug is indicated in the treatment of depressive states with anxiety or moderate to severe agitation, which are accompanied by tension, excitement, insomnia, obsessive and hypochondriac traits. It is also indicated in obsessive-compulsive disorder, panic attacks, stress disorder, post-traumatic disorder, social anxiety disorder and used to relieve the symptoms of premenstrual dysphoric disorder. | Drug | Drusen Mega® + Sertraline, Placebo + Sertraline |
| PlaceboAlso: Magnesium OxideIt consists of a placebo capsule composed of Magnesium Oxide 100mg. This component is inert in the dose at which it will be administered. | Drug | Placebo + Sertraline |
Primary outcome
Change from baseline in levels of Superoxide Dismutase (SOD)
Time frame: 90 days
Standard blood sampling will be collected through a catheter in an antecubital vein in tubes without EDTA, centrifuged and serum will placed in an eppendorf tube at -80 celsius degrees. The enzyme concentration will be determined with multiplex bead immunoassays technique and reported in microunits per milliliter units (mUI/mL)
Change from baseline in levels of Catalase (CAT)
Time frame: 90 days
Standard blood sampling will be collected through a catheter in an antecubital vein in tubes without EDTA, centrifuged and serum will placed in an eppendorf tube at -80 celsius degrees. The enzyme concentration will be determined with multiplex bead immunoassays technique and reported in microunits per milliliter units (mUI/mL)
Change from baseline in levels of Glutathione Peroxidase (GPx)
Time frame: 90 days
Standard blood sampling will be collected through a catheter in an antecubital vein in tubes without EDTA, centrifuged and serum will placed in an eppendorf tube at -80 celsius degrees. The enzyme concentration will be determined with multiplex bead immunoassays technique and reported in microunits per milliliter units (mUI/mL)
Change from baseline in levels of Malondialdehyde (MDA)
Time frame: 90 days
Standard blood sampling will be collected through a catheter in an antecubital vein in tubes without EDTA, centrifuged and serum will placed in an eppendorf tube at -80 celsius degrees. The enzyme concentration will be determined with multiplex bead immunoassays technique and reported in microunits per milliliter units (mUI/mL)
Change from baseline in levels of Oxidized Low-Density Lipoprotein LDL (oxLDL)
Time frame: 90 days
Standard blood sampling will be collected through a catheter in an antecubital vein in tubes without EDTA, centrifuged and serum will placed in an eppendorf tube at -80 celsius degrees. The enzyme concentration will be determined with multiplex bead immunoassays technique and reported in nanograms per milliliter units (ng/mL)
Change from baseline in levels of Tumor Necrosis Factor Alpha (TNF-a)
Time frame: 90 days
Standard blood sampling will be collected through a catheter in an antecubital vein in tubes without EDTA, centrifuged and serum will placed in an eppendorf tube at -80 celsius degrees. The cytokine concentration will be determined with multiplex bead immunoassays technique and reported in picogram per milliliter units (pg/mL)
Change from baseline in levels of Interleukin 8 (IL-8)
Time frame: 90 days
Standard blood sampling will be collected through a catheter in an antecubital vein in tubes without EDTA, centrifuged and serum will placed in an eppendorf tube at -80 celsius degrees. The cytokine concentration will be determined with multiplex bead immunoassays technique and reported in picogram per milliliter units (pg/mL)
Change from baseline in levels of Interleukin 6 (IL-6)
Time frame: 90 days
Standard blood sampling will be collected through a catheter in an antecubital vein in tubes without EDTA, centrifuged and serum will placed in an eppendorf tube at -80 celsius degrees. The cytokine concentration will be determined with multiplex bead immunoassays technique and reported in picogram per milliliter units (pg/mL)
Change from baseline in levels of Gamma Interferon (IFN-γ)
Time frame: 90 days
Standard blood sampling will be collected through a catheter in an antecubital vein in tubes without EDTA, centrifuged and serum will placed in an eppendorf tube at -80 celsius degrees. The cytokine concentration will be determined with multiplex bead immunoassays technique and reported in picogram per milliliter units (pg/mL)
Change from baseline in levels of Nuclear Factor Kappa B (NF-κB)
Time frame: 90 days
Standard blood sampling will be collected through a catheter in an antecubital vein in tubes without EDTA, centrifuged and serum will placed in an eppendorf tube at -80 celsius degrees. The cytokine concentration will be determined with multiplex bead immunoassays technique and reported in nanogram per milliliter units (ng/mL)
5 secondary outcomes
Change from baseline in Tinnitus Loudness (db) Assessment
Time frame: 90 days
Change from baseline in Tinnitus Frecuency (Hz) Assessment
Time frame: 90 days
Change from baseline in Audiometric Assessment
Time frame: 90 days
Change from baseline in Tinnitus Discomfort Assessment
Time frame: 90 days
Change from baseline in levels of Otolin-1
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Background: PubMed 16411806Henry JA, Dennis KC, Schechter MA. General review of tinnitus: prevalence, mechanisms, effects, and management. J Speech Lang Hear Res. 2005 Oct;48(5):1204-35. doi: 10.1044/1092-4388(2005/084).
- Background: PubMed 11801262Weber C, Arck P, Mazurek B, Klapp BF. Impact of a relaxation training on psychometric and immunologic parameters in tinnitus sufferers. J Psychosom Res. 2002 Jan;52(1):29-33. doi: 10.1016/s0022-3999(01)00281-1.
- Background: PubMed 33383894Gomaa NA, Jimoh Z, Campbell S, Zenke JK, Szczepek AJ. Biomarkers for Inner Ear Disorders: Scoping Review on the Role of Biomarkers in Hearing and Balance Disorders. Diagnostics (Basel). 2020 Dec 29;11(1):42. doi: 10.3390/diagnostics11010042.
- Background: PubMed 34273409Solis-Angeles S, Juarez-Perez CA, Jimenez-Ramirez C, Cabello-Lopez A, Aguilar-Madrid G, Del Razo LM. Prestin and otolin-1 proteins in the hearing loss of adults chronically exposed to lead. Toxicol Appl Pharmacol. 2021 Sep 1;426:115651. doi: 10.1016/j.taap.2021.115651. Epub 2021 Jul 15.
- Background: PubMed 29621860Esmaili AA, Renton J. A review of tinnitus. Aust J Gen Pract. 2018 Apr;47(4):205-208. doi: 10.31128/AJGP-12-17-4420.
- Background: PubMed 30464909Celik M, Koyuncu I. A Comprehensive Study of Oxidative Stress in Tinnitus Patients. Indian J Otolaryngol Head Neck Surg. 2018 Dec;70(4):521-526. doi: 10.1007/s12070-018-1464-7. Epub 2018 Jul 27.
- Background: 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.
- Background: PubMed 30510615Pawlak-Osinska K, Kazmierczak H, Marzec M, Kupczyk D, Bilski R, Mikolajewska E, Mikolajewski D, Augustynska B. Assessment of the State of the Natural Antioxidant Barrier of a Body in Patients Complaining about the Presence of Tinnitus. Oxid Med Cell Longev. 2018 Oct 28;2018:1439575. doi: 10.1155/2018/1439575. eCollection 2018.
- Background: 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 23827090Baguley D, McFerran D, Hall D. Tinnitus. Lancet. 2013 Nov 9;382(9904):1600-7. doi: 10.1016/S0140-6736(13)60142-7. Epub 2013 Jul 2.
- Individual participant dataSharing planned: No. IPD is not planned to be shared. The data is protected under the Mexican Federal Law for the Protection of Personal Data Held by Private Parties.
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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. This study is not recruiting at the moment.
Adolfo D Rodríguez-Carrizalez, MD / PhD principal investigator
University of Guadalajara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Drusen Mega® and Sertraline in people with Tinnitus, Subjective and Tinnitus, Bilateral, run by University of Guadalajara at 1 site in Mexico.
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 6 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 7 Apr 2023. 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 Mexico. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adolfo D. Rodríguez-Carrizalez, MD / PhD (+52 33 10585200, leinadkit@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in levels of Superoxide Dismutase (SOD) (time frame: 90 days). The study lists 10 primary outcomes in all. 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 NCT05646693, which also lists 10 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 7 Apr 2023.