Effect of Highly Bioavailable Curcumin on Subjective Tinnitus

April 18, 2023 updated by: Ascension South East Michigan
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • Michigan Ear Institute
      • Novi, Michigan, United States, 48374
        • Michigan Ear Institute
      • Royal Oak, Michigan, United States, 48073
        • Michigan Ear Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change on the Tinnitus Functional Index (TFI)
Time Frame: Evaluate at the beginning of the trial and at the end of the 30 day treatment period.
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)
Time Frame: Evaluate at the beginning of the trial and at the end of the 30 day treatment period.
Measure the Tinnitus Handicap Inventory.
Evaluate at the beginning of the trial and at the end of the 30 day treatment period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ascension South East Michigan

Investigators

  • Principal Investigator: Seilish Babu, MD, Michigan Ear Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2021

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

March 10, 2021

First Submitted That Met QC Criteria

March 15, 2021

First Posted (Actual)

March 16, 2021

Study Record Updates

Last Update Posted (Actual)

April 20, 2023

Last Update Submitted That Met QC Criteria

April 18, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1682516

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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