What is the mechanism of action of this treatment?

Common treatments for tinnitus often include anti-inflammatory and antioxidant agents, such as highly bioavailable curcumin. These treatments work by reducing inflammation and oxidative stress in the auditory pathways, which are believed to contribute to tinnitus. By mitigating these underlying factors, these treatments can potentially decrease the severity of tinnitus symptoms. This is crucial for patients as it can improve their quality of life by reducing the constant ringing or buzzing in their ears, which can be debilitating and affect daily activities.

What side effects are associated with this type of intervention?

Common treatments for tinnitus with anti-inflammatory and antioxidant properties include curcumin, omega-3 fatty acids, and alpha-lipoic acid. Curcumin is generally well-tolerated but can cause gastrointestinal issues such as nausea and diarrhea in some individuals. Omega-3 fatty acids may lead to mild side effects like fishy aftertaste, belching, and gastrointestinal discomfort. Alpha-lipoic acid is also typically well-tolerated but can cause skin rash, nausea, and in rare cases, hypoglycemia. It is important to consult with a healthcare provider to tailor treatment to individual needs and monitor for any adverse effects.

What prior FDA approvals exist?

As of now, there are no FDA-approved drugs specifically for the treatment of tinnitus. Treatments often focus on managing symptoms rather than curing the condition. While highly bioavailable curcumin is being studied for its potential benefits due to its anti-inflammatory and antioxidant properties, similar treatments have not yet received FDA approval for tinnitus. Current management strategies include hearing aids, sound therapy, and cognitive behavioral therapy, which aim to alleviate the impact of tinnitus on patients' quality of life.

What other types of research exist?

Promising novel alternatives to Highly Bioavailable Curcumin for tinnitus patients include: 1) Bevacizumab, which has shown efficacy in reducing vestibular schwannomas and improving hearing in NF2 patients, potentially benefiting tinnitus symptoms. 2) Transcutaneous Trigeminal Nerve Stimulation (TTNS), which has been explored for ADHD but may have potential applications in tinnitus due to its neuromodulatory effects. 3) Melatonin, which has shown benefits in sleep improvement and may help with tinnitus-related sleep disturbances. Patients should discuss these options with their healthcare provider to determine the best course of action.

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Curcumin for Tinnitus

N/A

Waitlist Available

Led By Seilish Babu, MD

Research Sponsored by Ascension South East Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults with subjective tinnitus due to sensorineural hearing loss as determined by routine audiogram.

Be older than 18 years old

Must not have

Adults with subjective tinnitus due to another cause

Timeline

Screening 3 weeks

Treatment Varies

Follow Up evaluate at the beginning of the trial and at the end of the 30 day treatment period.

Summary

This trial tests a pill with curcumin and boswellia for people with severe tinnitus due to hearing loss. The pill is designed to reduce ear inflammation and potentially decrease the ringing sound.

Who is the study for?

This trial is for adults who have ringing in their ears (tinnitus) because of hearing loss from nerve damage. They must not be allergic to the test compounds, pregnant, using other tinnitus treatments like certain medications or counseling, or taking blood thinners.

What is being tested?

The study is testing if a form of curcumin that's easy for the body to use can help with tinnitus. Participants will either get this special curcumin or a placebo and answer surveys about their tinnitus before and after treatment.

What are the potential side effects?

Curcumin might cause digestive upset, headaches, rashes, or yellow stool. It could also interact with other drugs. However, since it's generally considered safe at low doses, serious side effects are rare.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have tinnitus due to hearing loss, confirmed by a hearing test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have tinnitus not caused by hearing loss.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ evaluate at the beginning of the trial and at the end of the 30 day treatment period.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~evaluate at the beginning of the trial and at the end of the 30 day treatment period.

This trial's timeline: 3 weeks for screening, Varies for treatment, and evaluate at the beginning of the trial and at the end of the 30 day treatment period. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean change on the Tinnitus Functional Index (TFI)

Secondary study objectives

Determine Changes in the Tinnitus Handicap Inventory (THI)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Treatment GroupExperimental Treatment1 Intervention

Subjects will be provided with a supply of capsules containing 500 mg of curcumin-phosphatidylcholine combined with 250 mg of boswellia-phosphatidyl. Subjects will take 1 capsule by mouth twice daily for 30 days.

Group II: Placebo GroupPlacebo Group1 Intervention

Subjects will be provided with a placebo compound with instructions to take 1 capsule by mouth twice daily for 30 days.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for tinnitus often include anti-inflammatory and antioxidant agents, such as highly bioavailable curcumin. These treatments work by reducing inflammation and oxidative stress in the auditory pathways, which are believed to contribute to tinnitus. By mitigating these underlying factors, these treatments can potentially decrease the severity of tinnitus symptoms. This is crucial for patients as it can improve their quality of life by reducing the constant ringing or buzzing in their ears, which can be debilitating and affect daily activities.