Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2025-12-25 @ 1:12 AM
NCT ID:
NCT05646693
Eligibility 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 (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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
75 Years
Study:
NCT05646693
Study Brief:
Protocol Section:
NCT05646693