Ignite Creation Date:
2024-05-06 @ 3:55 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04800107
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-04-20
First Post:
2021-03-10
Brief Title:
Effect of Highly Bioavailable Curcumin on Subjective Tinnitus
Sponsor:
Ascension South East Michigan
Organization:
Ascension South East Michigan
Study Overview
Official Title:
Effect of Highly Bioavailable Curcumin on Subjective Tinnitus
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None