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Effect of Highly Bioavailable Curcumin on Subjective Tinnitus

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ClinicalTrials.gov Identifier: NCT04800107
Recruitment Status : Recruiting
First Posted : March 16, 2021
Last Update Posted : March 16, 2021
Sponsor:
Information provided by (Responsible Party):
Ascension South East Michigan

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.

Condition or disease Intervention/treatment Phase
Tinnitus, Subjective Biological: Curcumin-phosphatidylcholine Biological: Placebo capsule Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Subjects will be randomized to a treatment or placebo group after completing both the TFI and THI surveys.
Primary Purpose: Treatment
Official Title: Effect of Highly Bioavailable Curcumin on Subjective Tinnitus
Actual Study Start Date : January 6, 2021
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus
Drug Information available for: Curcumin

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 Name: 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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04800107


Contacts
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Contact: Seilish Babu, MD (248) 865-4444 sbabu@michiganear.com
Contact: Karl Doerfer, MD (248) 865-4444 kdoerfer@gmail.com

Locations
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United States, Michigan
Michigan Ear Institute Recruiting
Farmington Hills, Michigan, United States, 48334
Contact: Seilesh Babu, M.D.    248-865-4444    sbabu@michiganear.com   
Contact: Karl Doerfer, MD    (248) 865-4444    kdoerfer@gmail.com   
Michigan Ear Institute Recruiting
Novi, Michigan, United States, 48374
Contact: Seilish Babu, MD    248-865-4444    sbabu@michiganear.com   
Contact: Karl Doerfer, MD    (248) 865-4444    kdoerfer@gmail.com   
Michigan Ear Institute Recruiting
Royal Oak, Michigan, United States, 48073
Contact: SeIlish Babu, MD    248-865-4444    sbabu@michiganear.com   
Contact: Karl Doerfer, MD    (248) 865-4444    kdoerfer@gmail.com   
Sponsors and Collaborators
Ascension South East Michigan
Investigators
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Principal Investigator: Seilish Babu, MD Michigan Ear Institute
Publications:

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Responsible Party: Ascension South East Michigan
ClinicalTrials.gov Identifier: NCT04800107    
Other Study ID Numbers: 1682516
First Posted: March 16, 2021    Key Record Dates
Last Update Posted: March 16, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ascension South East Michigan:
Curcumin
Anti-inflammatory compound
Turmeric
Additional relevant MeSH terms:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action