Eligibility
18+
All Sexes
What conditions do you have?
Select
Study Summary
This trial will study whether highly bioavailable curcumin can help to reduce tinnitus symptoms.
Eligible Conditions
- Tinnitus, Subjective
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 1 Secondary · Reporting Duration: Evaluate at the beginning of the trial and at the end of the 30 day treatment period.
Day 30
Determine Changes in the Tinnitus Handicap Inventory (THI)
Mean change on the Tinnitus Functional Index (TFI)
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Treatment Group
1 of 2
Placebo Group
1 of 2
Experimental Treatment
Non-Treatment Group
110 Total Participants · 2 Treatment Groups
Primary Treatment: Curcumin-phosphatidylcholine · Has Placebo Group · N/A
Treatment Group
Biological
Experimental Group · 1 Intervention: Curcumin-phosphatidylcholine · Intervention Types: BiologicalPlacebo Group
Biological
PlaceboComparator Group · 1 Intervention: Placebo capsule · Intervention Types: BiologicalTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: evaluate at the beginning of the trial and at the end of the 30 day treatment period.
Who is running the clinical trial?
Ascension South East MichiganLead Sponsor
17 Previous Clinical Trials
3,080 Total Patients Enrolled
Seilish Babu, MDPrincipal InvestigatorMichigan Ear Institute
1 Previous Clinical Trials
6 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 1 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
Who else is applying?
What state do they live in?
| Michigan | 76.8% |
| New York | 4.9% |
| Texas | 3.7% |
| Other | 14.6% |
How old are they?
| 18 - 65 | 78.3% |
| 65+ | 17.4% |
| < 18 | 4.3% |
What site did they apply to?
| Michigan Ear Institute | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 93.9% |
| Did not meet criteria | 6.1% |
References
- Castañeda, Rodrigo, Sathishkumar Natarajan, Seo Yule Jeong, Bin Na Hong, and Tong Ho Kang. 2019. “Traditional Oriental Medicine for Sensorineural Hearing Loss: Can Ethnopharmacology Contribute to Potential Drug Discovery?”. Journal of Ethnopharmacology. Elsevier BV. doi:10.1016/j.jep.2018.11.016.
- Mirzaei, Hamed, Abolfazl Shakeri, Bahman Rashidi, Amin Jalili, Zarrin Banikazemi, and Amirhossein Sahebkar. 2017. “Phytosomal Curcumin: A Review of Pharmacokinetic, Experimental and Clinical Studies”. Biomedicine & Pharmacotherapy. Elsevier BV. doi:10.1016/j.biopha.2016.11.098.
- Soyalıç, Harun, Fikret Gevrek, Sema Koç, Mustafa Avcu, Mehmet Metin, and İbrahim Aladağ. 2016. “Intraperitoneal Curcumin and Vitamin E Combination for the Treatment of Cisplatin-induced Ototoxicity in Rats”. International Journal of Pediatric Otorhinolaryngology. Elsevier BV. doi:10.1016/j.ijporl.2016.08.012.
- Zeman, Florian, Michael Koller, Ricardo Figueiredo, Andreia Aazevedo, Marcello Rates, Claudia Coelho, Tobias Kleinjung, Dirk de Ridder, Berthold Langguth, and Michael Landgrebe. 2011. “Tinnitus Handicap Inventory for Evaluating Treatment Effects”. Otolaryngology–head and Neck Surgery. SAGE Publications. doi:10.1177/0194599811403882.
- Yamaguchi, Taro, Masanori Yoneyama, Yusuke Onaka, Atsushi Imaizumi, and Kiyokazu Ogita. 2017. “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”. Journal of Pharmacological Sciences. Elsevier BV. doi:10.1016/j.jphs.2017.07.003.
- Gupta, Subash C., Sridevi Patchva, and Bharat B. Aggarwal. 2012. “Therapeutic Roles of Curcumin: Lessons Learned from Clinical Trials”. The AAPS Journal. Springer Science and Business Media LLC. doi:10.1208/s12248-012-9432-8.
- Haryuna, Tengku, Wibi Riawan, Ardyansyah Nasution, Suprapto Ma'at, Juliandi Harahap, and Indri Adriztina. 2016. “Curcumin Reduces the Noise-exposed Cochlear Fibroblasts Apoptosis”. International Archives of Otorhinolaryngology. Georg Thieme Verlag KG. doi:10.1055/s-0036-1579742.
- Meikle, Mary B., James A. Henry, Susan E. Griest, Barbara J. Stewart, Harvey B. Abrams, Rachel McArdle, Paula J. Myers, et al.. 2012. “The Tinnitus Functional Index”. Ear & Hearing. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/aud.0b013e31822f67c0.
- Soyalıç, Harun, Fikret Gevrek, and Serhat Karaman. 2017. “Curcumin Protects Against Acoustic Trauma in the Rat Cochlea”. International Journal of Pediatric Otorhinolaryngology. Elsevier BV. doi:10.1016/j.ijporl.2017.05.029.
- 2021. "Effect of Highly Bioavailable Curcumin on Subjective Tinnitus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04800107.
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