Effect of Combined Antioxidant Therapy on Oxidative Stress Markers and Inflammatory Cytokines in … (NCT05646693) | Clinical Trial Compass
UnknownPhase 2
Effect of Combined Antioxidant Therapy on Oxidative Stress Markers and Inflammatory Cytokines in Patients With Tinnitus
Mexico58 participantsStarted 2022-12-01
Plain-language 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.
Who can participate
Age range
25 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
* …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in levels of Superoxide Dismutase (SOD)
Timeframe: 90 days
2
Change from baseline in levels of Catalase (CAT)
Timeframe: 90 days
3
Change from baseline in levels of Glutathione Peroxidase (GPx)
Timeframe: 90 days
4
Change from baseline in levels of Malondialdehyde (MDA)
Timeframe: 90 days
5
Change from baseline in levels of Oxidized Low-Density Lipoprotein LDL (oxLDL)
Timeframe: 90 days
6
Change from baseline in levels of Tumor Necrosis Factor Alpha (TNF-a)
Timeframe: 90 days
7
Change from baseline in levels of Interleukin 8 (IL-8)