CompletedNot Applicable

Short-term Oral Prednisone for Acute Subjective Tinnitus

China146 participantsStarted 2022-10-30

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 18-65 years old;
✓. a primary complaint of frequent occurrences of subjective tinnitus lasting at least 5 minutes within the past 3 months ;
✓. a definition of normal hearing in line with the World Report on Hearing (2021), of which the average value of hearing threshold at 500, 1000, 2000, 4000 Hz in better ear was less than 20 decibels;
✓. a score of more than 16 points on the Tinnitus Handicap Inventory (THI), which indicates that the level of tinnitus exceeds mild severity;
✓. a state of good general condition.

Exclusion criteria

✕. had previous history of middle ear pathology, apparent history of noise exposure, noise trauma or head injury;
✕. had received treatment for their current condition before the study;
✕. taken oral steroids within 3 months before randomization;
✕. had hearing implants;
✕. had participated in other clinical trials and have not terminated the trials;
✕. had a history of known corticosteroid contraindications (including osteoporosis, peptic ulcers, poorly controlled hypertension, diabetes, chronic liver or renal insufficiency, tumorous condition, alcohol abuse, pregnancy, or taking estrogen-containing oral contraceptive steroids);
✕. auditory hallucinations or other conditions deemed inappropriate for inclusion by the investigator.

What they're measuring

tinnitus handicap inventory (THI)

Timeframe: two weeks from baseline

tinnitus handicap inventory (THI)

Timeframe: four weeks from baseline

tinnitus handicap inventory (THI)

Timeframe: twelve weeks from baseline

Trial details

NCT IDNCT05591144

SponsorEye & ENT Hospital of Fudan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-01-22

View on ClinicalTrials.gov More Tinnitus, Subjective trials

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 18-65 years old;
✓. a primary complaint of frequent occurrences of subjective tinnitus lasting at least 5 minutes within the past 3 months ;
✓. a definition of normal hearing in line with the World Report on Hearing (2021), of which the average value of hearing threshold at 500, 1000, 2000, 4000 Hz in better ear was less than 20 decibels;
✓. a score of more than 16 points on the Tinnitus Handicap Inventory (THI), which indicates that the level of tinnitus exceeds mild severity;
✓. a state of good general condition.

Exclusion criteria

✕. had previous history of middle ear pathology, apparent history of noise exposure, noise trauma or head injury;
✕. had received treatment for their current condition before the study;
✕. taken oral steroids within 3 months before randomization;
✕. had hearing implants;
✕. had participated in other clinical trials and have not terminated the trials;
✕. had a history of known corticosteroid contraindications (including osteoporosis, peptic ulcers, poorly controlled hypertension, diabetes, chronic liver or renal insufficiency, tumorous condition, alcohol abuse, pregnancy, or taking estrogen-containing oral contraceptive steroids);
✕. auditory hallucinations or other conditions deemed inappropriate for inclusion by the investigator.