Effect of Combined Antioxidant Therapy on Oxidative Stress Markers and Inflammatory Cytokines in Patients With Tinnitus
NCT ID: NCT05646693
Last Updated: 2023-04-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
58 participants
INTERVENTIONAL
2022-12-01
2024-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Drug-drug Interaction Study of Ozanimod With Tyramine to Evaluate the Effect on Pressor Response
NCT03694119
Evaluation of the Drug-drug Interaction Between Ticagrelor and Venlafaxine When Taken Together in Healthy Volunteers
NCT01350921
Pharmacokinetic Drug Interaction Study of Dapagliflozin and Valsartan or Simvastatin in Healthy Subjects
NCT00839683
Drug-Drug Interaction Study Between EDP-235, Itraconazole, Carbamazepine and Quinidine in Healthy Subjects.
NCT05594602
Drug Interaction Study of ZYN002 Transdermal Gel and Probe Substrates
NCT06930872
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Drusen Mega® + Sertraline
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.
Drusen Mega®
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.
Sertraline
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.
Placebo + Sertraline
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.
Sertraline
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.
Placebo
It consists of a placebo capsule composed of Magnesium Oxide 100mg. This component is inert in the dose at which it will be administered.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Drusen Mega®
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.
Sertraline
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.
Placebo
It consists of a placebo capsule composed of Magnesium Oxide 100mg. This component is inert in the dose at which it will be administered.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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)
* 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
25 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Institute of Experimental and Clinical Therapeutics
UNKNOWN
Hospital Civil de Guadalajara
OTHER
University of Guadalajara
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Adolfo Daniel Rodriguez-Carrizalez
Research Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Adolfo D Rodríguez-Carrizalez, MD / PhD
Role: PRINCIPAL_INVESTIGATOR
University of Guadalajara
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Institute of Experimental and Clinical Therapeutics,
Guadalajara, Jalisco, Mexico
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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).
Weber 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.
Gomaa 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.
Solis-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.
Esmaili AA, Renton J. A review of tinnitus. Aust J Gen Pract. 2018 Apr;47(4):205-208. doi: 10.31128/AJGP-12-17-4420.
Celik 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.
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.
Pawlak-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.
Petridou 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.
Baguley 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ACSE202208/IIA
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.