Effect of Combined Antioxidant Therapy on Oxidative Stress Markers and Inflammatory Cytokines in Patients With Tinnitus

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

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.

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Guadalajara
• Collaborators: Hospital Civil de Guadalajara; Institute of Experimental and Clinical Therapeutics
• Treatments: Magnesium Oxide

Criteria

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 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)

• 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