Effect of Highly Bioavailable Curcumin on Subjective Tinnitus

Ascension South East Michigan

Status: Active, not recruiting

Conditions: Tinnitus, Subjective

Treatments: Biological: Placebo capsule; Biological: Curcumin-phosphatidylcholine

Study type: Interventional

Funder types: Other

Identifiers

NCT04800107

1682516

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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110 participants in 2 patient groups, including a placebo group

Treatment Group

Experimental group

Description:

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.

Treatment:

Biological: Curcumin-phosphatidylcholine

Placebo Group

Placebo Comparator group

Description:

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

Treatment:

Biological: Placebo capsule