Tinnitus, SubjectiveNCT04800107
Effect of Highly Bioavailable Curcumin on Subjective Tinnitus
A study testing Curcumin-phosphatidylcholine in people with Tinnitus, Subjective, run by Henry Ford Health System at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Tinnitus, Subjective
- What is being tested?
- Curcumin-phosphatidylcholine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- 6 Jan 2021to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with subjective tinnitus due to sensorineural hearing loss as determined by routine audiogram.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Michigan Ear Institute
Farmington Hills, Michigan, 48334
Michigan Ear Institute
Novi, Michigan, 48374
Michigan Ear Institute
Royal Oak, Michigan, 48073
About this study
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.
Read the 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.
- Conditions
- Tinnitus, Subjective
- Being tested
- Curcumin-phosphatidylcholine, Placebo capsule
- Keywords
- Curcumin, Anti-inflammatory compound, Turmeric
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curcumin-phosphatidylcholineBiological
Also called Tumeric
500 mg of curcumin-phosphatidylcholine combined with 250 mg of boswellia-phosphatidyl
Placebo capsuleBiological
Placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: Placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change on the Tinnitus Functional Index (TFI)
Administer the TFI survey
Measured: 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)
Measure the Tinnitus Handicap Inventory.
Measured: Evaluate at the beginning of the trial and at the end of the 30 day treatment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start6 Jan 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Why it stopped: Study was not pursued after joint venture completed with Henry Ford Health.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Tinnitus, SubjectiveStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Seilish Babu, MD, Principal investigator, Michigan Ear Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04800107
- Sponsor's protocol ID
- 1682516
- Status last verified
- Sep 2026
- First submitted
- 10 Mar 2021
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28688549Haryuna 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.
PubMed 27746842Soyalic 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.
PubMed 27619052Mirzaei 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.
PubMed 27930973Yamaguchi 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.
PubMed 28826625Gupta 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.
PubMed 23143785Castaneda 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.
PubMed 30439402Meikle 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.
PubMed 22156949Zeman 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.
PubMed 21493265
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Highly Bioavailable Curcumin on Subjective Tinnitus
- ClinicalTrials.gov ID
- NCT04800107
- Acronym / sponsor ID
- 1682516
- Conditions
- Tinnitus, Subjective
- Keywords
- Curcumin, Anti-inflammatory compound, Turmeric
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was not pursued after joint venture completed with Henry Ford Health.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 6 Jan 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Biological: Curcumin-phosphatidylcholineSubjects 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. |
| Placebo Group | Placebo comparator | Biological: Placebo capsuleSubjects will be provided with a placebo compound with instructions to take 1 capsule by mouth twice daily for 30 days. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults with subjective tinnitus due to sensorineural hearing loss as determined by routine audiogram.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Curcumin-phosphatidylcholineAlso: Tumeric500 mg of curcumin-phosphatidylcholine combined with 250 mg of boswellia-phosphatidyl | Biological | Treatment Group |
| Placebo capsulePlacebo capsule | Biological | Placebo Group |
Primary outcome
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
1 secondary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Background: PubMed 28688549Soyalic 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.
- Background: PubMed 27746842Haryuna 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.
- Background: PubMed 27619052Soyalic 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.
- Background: PubMed 27930973Mirzaei 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.
- Background: PubMed 28826625Yamaguchi 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.
- Background: PubMed 23143785Gupta 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.
- Background: PubMed 30439402Castaneda 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.
- Background: PubMed 22156949Meikle 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.
- Background: PubMed 21493265Zeman 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.
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COMPARISON OF MANUAL THERAPY, TINNITUS RETRAINING THERAPY
Somatosensory Tinnitus, Subjektif tınnitus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seilish Babu, MD principal investigator
Michigan Ear Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Curcumin-phosphatidylcholine in people with Tinnitus, Subjective, run by Henry Ford Health System at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04800107, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.