Clinical trial NCT04800107: Effect of Highly Bioavailable Curcumin on Subjective Tinnitus
Official title: Effect of Highly Bioavailable Curcumin on Subjective Tinnitus
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Tinnitus, Subjective
Keywords: Curcumin
Anti-inflammatory compound
Turmeric
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2021-03-16
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the effectiveness of highly bioavailable curcumin in suppressing subjective tinnitus based on pre- and post-treatment evaluations using the validated Tinnitus Functional Index (TFI) and Tinnitus Handicap Inventory (THI) surveys.

Detailed description: Subjects with severe, subjective tinnitus due to sensorineural hearing loss will complete both TFI and THI surveys prior to starting therapy. Subjects will then be randomized to a treatment or placebo group. The treatment group will be provided with a supply of capsules containing 500 mg of curcumin-phosphatidylcholine combined with 250 mg of boswellia-phosphatidylcholine, which increases curcumin bioavailability. Subjects in the treatment arm will be instructed to take 1 capsule by mouth twice daily for 30 days. Placebo group subjects will be provided with a placebo compound with instructions to take the same number of capsules by mouth for the same period of time. Both the active compound and the placebo will be provided by Smartceuticals, Inc (910 W. Van Buren St. Ste 100-376 Chicago, IL 60607) to the outpatient pharmacy at Ascension Providence Park (Novi, MI), which will be responsible for storage, distribution and tracking. After 30 days, patients will be asked to return bottles to the pharmacy with any unused capsules to confirm and monitor compliance. Placebo and active agent capsules and bottles will be identical in appearance with the exception of a unique alphanumeric code on the bottle label that identifies whether the distributed capsules contain active agent or placebo. This code will be matched to the participating subject by the pharmacy and will be used at the end of the study to determine which treatment arm each subject was in. To facilitate blinding, the master list of alphanumeric codes will be maintained by the manufacturer. At the completion of therapy, subjects from both groups will re-take the TFI and THI.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Adults with subjective tinnitus due to another cause
* Sensitivity or allergy to test compounds
* Use of other off-label medications, substances, treatments specifically for tinnitus mitigation (e.g., anti-depressant/anxiety medications, GABA-inhibitors, psychiatric-based interventions/counseling)
* Pregnancy
* Patients taking anticoagulants to minimize risk of drug-drug interactions.

Primary outcomes:
measure: Mean change on the Tinnitus Functional Index (TFI)
timeFrame: Evaluate at the beginning of the trial and at the end of the 30 day treatment period.
Secondary outcomes:
measure: Determine Changes in the Tinnitus Handicap Inventory (THI)
timeFrame: Evaluate at the beginning of the trial and at the end of the 30 day treatment period.
Other outcomes:
Locations:
city: Farmington Hills
country: United States
facility: Michigan Ear Institute
state: Michigan
city: Novi
country: United States
facility: Michigan Ear Institute
state: Michigan
city: Royal Oak
country: United States
facility: Michigan Ear Institute
state: Michigan
Study officials:
affiliation: Michigan Ear Institute
name: Seilish Babu, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Gupta SC, Patchva S, Aggarwal BB. Therapeutic roles of curcumin: lessons learned from clinical trials. AAPS J. 2013 Jan;15(1):195-218. doi: 10.1208/s12248-012-9432-8. Epub 2012 Nov 10.
citation: Castaneda R, Natarajan S, Jeong SY, Hong BN, Kang TH. Traditional oriental medicine for sensorineural hearing loss: Can ethnopharmacology contribute to potential drug discovery? J Ethnopharmacol. 2019 Mar 1;231:409-428. doi: 10.1016/j.jep.2018.11.016. Epub 2018 Nov 12.
citation: Meikle MB, Henry JA, Griest SE, Stewart BJ, Abrams HB, McArdle R, Myers PJ, Newman CW, Sandridge S, Turk DC, Folmer RL, Frederick EJ, House JW, Jacobson GP, Kinney SE, Martin WH, Nagler SM, Reich GE, Searchfield G, Sweetow R, Vernon JA. The tinnitus functional index: development of a new clinical measure for chronic, intrusive tinnitus. Ear Hear. 2012 Mar-Apr;33(2):153-76. doi: 10.1097/AUD.0b013e31822f67c0.
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