NCT04800107

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 6, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 16, 2021

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 20, 2023

Status Verified

April 1, 2023

Enrollment Period

5 years

First QC Date

March 10, 2021

Last Update Submit

April 18, 2023

Conditions

Tinnitus, Subjective

Keywords

CurcuminAnti-inflammatory compoundTurmeric

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Determine Changes in the Tinnitus Handicap Inventory (THI)

    Evaluate at the beginning of the trial and at the end of the 30 day treatment period.

Study Arms (2)

Treatment Group

EXPERIMENTAL

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

Placebo Group

PLACEBO COMPARATOR

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

Biological: Placebo capsule

Interventions

Curcumin-phosphatidylcholineBIOLOGICAL

500 mg of curcumin-phosphatidylcholine combined with 250 mg of boswellia-phosphatidyl

Also known as: Tumeric
Treatment Group
Placebo capsuleBIOLOGICAL

Placebo capsule

Placebo Group

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults with subjective tinnitus due to sensorineural hearing loss as determined by routine audiogram.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Michigan Ear Institute

Farmington Hills, Michigan, 48334, United States

Location

Michigan Ear Institute

Novi, Michigan, 48374, United States

Location

Michigan Ear Institute

Royal Oak, Michigan, 48073, United States

Location

Related Publications (9)

  • Soyalic H, Gevrek F, Karaman S. Curcumin protects against acoustic trauma in the rat cochlea. Int J Pediatr Otorhinolaryngol. 2017 Aug;99:100-106. doi: 10.1016/j.ijporl.2017.05.029. Epub 2017 Jun 5.

    PMID: 28688549BACKGROUND

  • Haryuna TS, Riawan W, Nasution A, Ma'at S, Harahap J, Adriztina I. Curcumin Reduces the Noise-Exposed Cochlear Fibroblasts Apoptosis. Int Arch Otorhinolaryngol. 2016 Oct;20(4):370-376. doi: 10.1055/s-0036-1579742. Epub 2016 Mar 4.

    PMID: 27746842BACKGROUND

  • Soyalic H, Gevrek F, Koc S, Avcu M, Metin M, Aladag I. Intraperitoneal curcumin and vitamin E combination for the treatment of cisplatin-induced ototoxicity in rats. Int J Pediatr Otorhinolaryngol. 2016 Oct;89:173-8. doi: 10.1016/j.ijporl.2016.08.012. Epub 2016 Aug 24.

    PMID: 27619052BACKGROUND

  • Mirzaei H, Shakeri A, Rashidi B, Jalili A, Banikazemi Z, Sahebkar A. Phytosomal curcumin: A review of pharmacokinetic, experimental and clinical studies. Biomed Pharmacother. 2017 Jan;85:102-112. doi: 10.1016/j.biopha.2016.11.098. Epub 2016 Dec 5.

    PMID: 27930973BACKGROUND

  • Yamaguchi T, Yoneyama M, Onaka Y, Imaizumi A, Ogita K. Preventive effect of curcumin and its highly bioavailable preparation on hearing loss induced by single or repeated exposure to noise: A comparative and mechanistic study. J Pharmacol Sci. 2017 Aug;134(4):225-233. doi: 10.1016/j.jphs.2017.07.003. Epub 2017 Aug 8.

    PMID: 28826625BACKGROUND

  • Gupta SC, Patchva S, Aggarwal BB. Therapeutic roles of curcumin: lessons learned from clinical trials. AAPS J. 2013 Jan;15(1):195-218. doi: 10.1208/s12248-012-9432-8. Epub 2012 Nov 10.

    PMID: 23143785BACKGROUND

  • Castaneda R, Natarajan S, Jeong SY, Hong BN, Kang TH. Traditional oriental medicine for sensorineural hearing loss: Can ethnopharmacology contribute to potential drug discovery? J Ethnopharmacol. 2019 Mar 1;231:409-428. doi: 10.1016/j.jep.2018.11.016. Epub 2018 Nov 12.

    PMID: 30439402BACKGROUND

  • Meikle MB, Henry JA, Griest SE, Stewart BJ, Abrams HB, McArdle R, Myers PJ, Newman CW, Sandridge S, Turk DC, Folmer RL, Frederick EJ, House JW, Jacobson GP, Kinney SE, Martin WH, Nagler SM, Reich GE, Searchfield G, Sweetow R, Vernon JA. The tinnitus functional index: development of a new clinical measure for chronic, intrusive tinnitus. Ear Hear. 2012 Mar-Apr;33(2):153-76. doi: 10.1097/AUD.0b013e31822f67c0.

    PMID: 22156949BACKGROUND

  • Zeman F, Koller M, Figueiredo R, Aazevedo A, Rates M, Coelho C, Kleinjung T, de Ridder D, Langguth B, Landgrebe M. Tinnitus handicap inventory for evaluating treatment effects: which changes are clinically relevant? Otolaryngol Head Neck Surg. 2011 Aug;145(2):282-7. doi: 10.1177/0194599811403882.

    PMID: 21493265BACKGROUND

MeSH Terms

Conditions

Tinnitus

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DiarylheptanoidsHeptanesAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Officials

  • Seilish Babu, MD

    Michigan Ear Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Subjects will be randomized to a treatment or placebo group after completing both the TFI and THI surveys.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2021

First Posted

March 16, 2021

Study Start

January 6, 2021

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

April 20, 2023

Record last verified: 2023-04

Locations

US(3)