Effect of Highly Bioavailable Curcumin on Subjective Tinnitus

Tinnitus, Subjective Clinical Trial

Official title:

Effect of Highly Bioavailable Curcumin on Subjective Tinnitus

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04800107
• Other study ID #: 1682516
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 6, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2023
• Source: Ascension South East Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 110
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tinnitus
• Tinnitus, Subjective

Intervention

Biological:
• Curcumin-phosphatidylcholine
500 mg of curcumin-phosphatidylcholine combined with 250 mg of boswellia-phosphatidyl
• Placebo capsule
Placebo capsule

Locations

Country	Name	City	State
United States	Michigan Ear Institute	Farmington Hills	Michigan
United States	Michigan Ear Institute	Novi	Michigan
United States	Michigan Ear Institute	Royal Oak	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Ascension South East Michigan

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Ear Hear. 2012 May;33(3):443. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.