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

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.

Conditions

• Tinnitus, Subjective
• Tinnitus, Bilateral
• Antioxidant Therapy
• Psychiatric Drugs
• Oxidative Stress
• Inflammatory Cytokines
• SSRI

Interventions

DIETARY_SUPPLEMENT

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.

DRUG

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.

DRUG

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.

Sponsors & Collaborators

• Institute of Experimental and Clinical Therapeutics

  collaborator UNKNOWN

• Hospital Civil de Guadalajara

  collaborator OTHER

• University of Guadalajara

  lead OTHER

Principal Investigators

• Adolfo D Rodríguez-Carrizalez, MD / PhD · University of Guadalajara

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

25 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-12-01

Primary Completion

2023-12-31

Completion

2024-12-31

Countries

• Mexico

Study Locations