Short-term Oral Prednisone for Acute Subjective Tinnitus

Last updated: February 26, 2025
Sponsor: Eye & ENT Hospital of Fudan University
Overall Status: Completed

Phase

N/A

Condition

Tinnitus

Deafness

Hearing Loss

Treatment

Prednisone tablet

Ginkgo Biloba Extract

Clinical Study ID

NCT05591144
STOP for AST
  • Ages 18-65
  • All Genders

Study Summary

The goal of this clinical trial is to investigate the efficacy of oral steroids in the acute tinnitus population. Participants will receive appropriate dosages of short-term prednisone and/or oral Ginkgo Biloba tablets.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 18-65 years old;

  2. a primary complaint of frequent occurrences of subjective tinnitus lasting at least 5 minutes within the past 3 months ;

  3. a definition of normal hearing in line with the World Report on Hearing (2021), ofwhich the average value of hearing threshold at 500, 1000, 2000, 4000 Hz in betterear was less than 20 decibels;

  4. a score of more than 16 points on the Tinnitus Handicap Inventory (THI), whichindicates that the level of tinnitus exceeds mild severity;

  5. a state of good general condition.

Exclusion

Exclusion Criteria:

  1. had previous history of middle ear pathology, apparent history of noise exposure,noise trauma or head injury;

  2. had received treatment for their current condition before the study;

  3. taken oral steroids within 3 months before randomization;

  4. had hearing implants;

  5. had participated in other clinical trials and have not terminated the trials;

  6. had a history of known corticosteroid contraindications (including osteoporosis,peptic ulcers, poorly controlled hypertension, diabetes, chronic liver or renalinsufficiency, tumorous condition, alcohol abuse, pregnancy, or takingestrogen-containing oral contraceptive steroids);

  7. auditory hallucinations or other conditions deemed inappropriate for inclusion bythe investigator.

Study Design

Total Participants: 146
Treatment Group(s): 2
Primary Treatment: Prednisone tablet
Phase:
Study Start date:
October 30, 2022
Estimated Completion Date:
February 03, 2024

Study Description

Researchers will compare the intervention group and placebo-control group to see whether short-term systemic steroid therapy is effective for acute tinnitus.

Connect with a study center

  • Eye and ENT Hospital of Fudan University

    Shanghai,
    China

    Site Not Available

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