Clinical trial

Effect of Combined Antioxidant Therapy on Oxidative Stress Markers and Inflammatory in Patients With Chronic Subjective Endotic Tinnitus

Name

ACSE202208/IIA

Description

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.

Trial arms

Trial start

2022-12-01

Estimated PCD

2023-12-31

Trial end

2024-12-31

Status

Recruiting

Phase

Early phase I

Treatment

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.

Arms:

Drusen Mega® + Sertraline

Other names:

Multivitamins

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.

Arms:

Drusen Mega® + Sertraline, Placebo + Sertraline

Other names:

Sertraline Hydrochloride

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.

Arms:

Placebo + Sertraline

Other names:

Magnesium Oxide

Size

Primary endpoint

Change from baseline in levels of Superoxide Dismutase (SOD)

90 days

Change from baseline in levels of Catalase (CAT)

90 days

Change from baseline in levels of Glutathione Peroxidase (GPx)

90 days

Change from baseline in levels of Malondialdehyde (MDA)

90 days

Change from baseline in levels of Oxidized Low-Density Lipoprotein LDL (oxLDL)

90 days

Change from baseline in levels of Tumor Necrosis Factor Alpha (TNF-a)

90 days

Change from baseline in levels of Interleukin 8 (IL-8)

90 days

Change from baseline in levels of Interleukin 6 (IL-6)

90 days

Change from baseline in levels of Gamma Interferon (IFN-γ)

90 days

Change from baseline in levels of Nuclear Factor Kappa B (NF-κB)

90 days

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Clinical Trial Phase II A, controlled with placebo', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Double', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 58, 'type': 'ESTIMATED'}}

Updated at

2023-04-07

1 organization

1 product

1 drug

8 indications

Organization

University of Guadalajara

Product

Sertraline

Indication

Tinnitus