Effect of Highly Bioavailable Curcumin on Subjective Tinnitus

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Highly Bioavailable Curcumin on Subjective Tinnitus

Conditions
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Tinnitus, Subjective

Intervention / Treatment
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* Biological: Curcumin-phosphatidylcholine
* Biological: Placebo capsule


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>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. | Biological: Curcumin-phosphatidylcholine<br>* 500 mg of curcumin-phosphatidylcholine combined with 250 mg of boswellia-phosphatidyl<br>* Other names: Tumeric;|
| Placebo Comparator: Placebo Group<br>Subjects will be provided with a placebo compound with instructions to take 1 capsule by mouth twice daily for 30 days. | Biological: Placebo capsule<br>* Placebo capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change on the Tinnitus Functional Index (TFI) | Administer the TFI survey | Evaluate at the beginning of the trial and at the end of the 30 day treatment period. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine Changes in the Tinnitus Handicap Inventory (THI) | Measure the Tinnitus Handicap Inventory. | Evaluate at the beginning of the trial and at the end of the 30 day treatment period. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Curcumin, Anti-inflammatory compound, Turmeric