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临床试验/NCT04800107
NCT04800107进行中(未招募)不适用

Effect of Highly Bioavailable Curcumin on Subjective Tinnitus

Ascension South East Michigan4 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2021年1月6日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
110
试验地点
4
主要终点
Mean change on the Tinnitus Functional Index (TFI)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

盲法说明

Subjects will be randomized to a treatment or placebo group after completing both the TFI and THI surveys.

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Mean change on the Tinnitus Functional Index (TFI)

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

Administer the TFI survey

次要结局

  • 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.)

研究者

发起方
Ascension South East Michigan
申办方类型
Other
责任方
Sponsor

研究点 (4)

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