Curcumin for Tinnitus

Recruiting at 2 trial locations

Overseen By Karl Doerfer, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Henry Ford Health System

Must not be taking: Antidepressants, GABA-inhibitors, Anticoagulants

Disqualifiers: Pregnancy, Allergy, Other tinnitus causes, others

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

110 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using medications specifically for tinnitus or taking anticoagulants.

What data supports the effectiveness of the treatment Highly Bioavailable Curcumin for tinnitus?

Research shows that curcumin, known for its antioxidant properties, can protect against ear damage in animal studies and reduce discomfort in tinnitus patients when used as part of antioxidant therapy. ^{1 2 3 4 5}

Is curcumin safe for human use?

Curcumin is generally safe for humans when taken by mouth in doses up to 8,000 mg per day for 3 months, with no significant toxicity reported. However, excessive intake may have adverse effects on the kidneys, heart, liver, blood, and immune system. ^{6 7 8 9 10}

How does the drug curcumin differ from other treatments for tinnitus?

Curcumin, especially in its highly bioavailable form, is unique because it has shown potential in protecting against hearing loss by reducing oxidative stress and inflammation in the ear, which are not typical targets of standard tinnitus treatments. This makes it a novel option compared to existing therapies that often focus on symptom management rather than addressing underlying cellular damage. ^{1 4 11 12 13}

Research Team

Seilish Babu, MD

Principal Investigator

Michigan Ear Institute

Eligibility Criteria

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.

Inclusion Criteria

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

Exclusion Criteria

You are sensitive or allergic to the test drugs.

I am not using off-label treatments for tinnitus.

I am on blood thinners to avoid medication interactions.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the active compound or placebo for 30 days

4 weeks

1 visit (in-person) at the start, 1 visit (in-person) at the end

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Highly Bioavailable Curcumin

Trial Overview 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.

Participant Groups

Group I: Treatment Group Experimental Treatment 1 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 Group Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Henry Ford Health System

Lead Sponsor

Trials

334

Recruited

2,197,000+

Ascension South East Michigan

Lead Sponsor

Trials

19

Recruited

32,400+

Findings from Research

Curcumin, the active component in turmeric, shows promise in treating various health issues, including inflammation, cancer, and neurodegenerative diseases, but faces challenges in clinical application due to low solubility and poor bioavailability.

Despite its potential benefits, excessive intake of curcumin can lead to adverse effects on organs such as the kidneys, heart, and liver, highlighting the need for caution and further research before widespread clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comprehensive Review on the Benefits and Problems of Curcumin with Respect to Human Health. Liu, S., Liu, J., He, L., et al.[2022]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Curcumin protects against acoustic trauma in the rat cochlea. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

The Anti-Inflammatory and Antioxidant Effects of Curcumin in Middle Ear Infection. [2018]

3. Iran pubmed.ncbi.nlm.nih.gov

Curcumin Prevents Ototoxicity Induced by Cisplatin as Evaluated with OAE. [2023]

4. Ireland pubmed.ncbi.nlm.nih.gov

Intraperitoneal curcumin and vitamin E combination for the treatment of cisplatin-induced ototoxicity in rats. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

The Effect of Antioxidant Supplementation in Patients with Tinnitus and Normal Hearing or Hearing Loss: A Randomized, Double-Blind, Placebo Controlled Trial. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Pharmacokinetics, Pharmacodynamics, and PKPD Modeling of Curcumin in Regulating Antioxidant and Epigenetic Gene Expression in Healthy Human Volunteers. [2020]

7. Switzerland pubmed.ncbi.nlm.nih.gov

A Comprehensive Review on the Benefits and Problems of Curcumin with Respect to Human Health. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Nanoparticle-Formulated Curcumin Prevents Posttherapeutic Disease Reactivation and Reinfection with Mycobacterium tuberculosis following Isoniazid Therapy. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Nose-to-brain delivery of self-assembled curcumin-lactoferrin nanoparticles: Characterization, neuroprotective effect and in vivo pharmacokinetic study. [2023]

10. Greece pubmed.ncbi.nlm.nih.gov

Phase I clinical trial of curcumin, a chemopreventive agent, in patients with high-risk or pre-malignant lesions. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Curcumin-Encapsulated Chitosan-Coated Nanoformulation as an Improved Otoprotective Strategy for Ototoxic Hearing Loss. [2022]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Dose-dependent bioavailability indicators for curcumin and two of its novel derivatives. [2014]

13. Japan pubmed.ncbi.nlm.nih.gov

Preventive effect of curcumin and its highly bioavailable preparation on hearing loss induced by single or repeated exposure to noise: A comparative and mechanistic study. [2022]