Oxidative Stress Clinical Trial
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.
Status | Recruiting |
Enrollment | 58 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 25 Years to 75 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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) - 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 |
Country | Name | City | State |
---|---|---|---|
Mexico | Institute of Experimental and Clinical Therapeutics, | Guadalajara | Jalisco |
Lead Sponsor | Collaborator |
---|---|
University of Guadalajara | Hospital Civil de Guadalajara, Institute of Experimental and Clinical Therapeutics |
Mexico,
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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. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | 90 days | |
Primary | 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) | 90 days | |
Primary | 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) | 90 days | |
Primary | 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) | 90 days | |
Primary | 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) | 90 days | |
Primary | 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) | 90 days | |
Primary | 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) | 90 days | |
Primary | 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) | 90 days | |
Primary | Change from baseline in levels of Gamma Interferon (IFN-?) | 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) | 90 days | |
Primary | Change from baseline in levels of Nuclear Factor Kappa B (NF-?B) | 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) | 90 days | |
Secondary | 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 | 90 days | |
Secondary | 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. | 90 days | |
Secondary | 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. | 90 days | |
Secondary | 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. | 90 days | |
Secondary | 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. | 90 days |
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