Short-term Oral Prednisone for Acute Subjective Tinnitus (STOP-FAST)

Eye & ENT Hospital of Fudan University

Status: Completed

Conditions: Tinnitus, Subjective

Treatments: Drug: Ginkgo Biloba Extract; Drug: Prednisone tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT05591144

STOP for AST

Details and patient eligibility

About

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.

Full description

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

Enrollment: 146 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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), of which the average value of hearing threshold at 500, 1000, 2000, 4000 Hz in better ear was less than 20 decibels;
4. a score of more than 16 points on the Tinnitus Handicap Inventory (THI), which indicates that the level of tinnitus exceeds mild severity;
5. a state of good general condition.

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 renal insufficiency, tumorous condition, alcohol abuse, pregnancy, or taking estrogen-containing oral contraceptive steroids);
7. auditory hallucinations or other conditions deemed inappropriate for inclusion by the investigator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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146 participants in 2 patient groups, including a placebo group

STOP group

Experimental group

Description:

a 10mg/d tapering 14-day course of oral prednisone intervention (the initial dose: 1mg/kg/day, max 60mg/day) in combination with ginkgo biloba agent (120mg, three times/day)

Treatment:

Drug: Prednisone tablet

Drug: Ginkgo Biloba Extract

placebol group

Placebo Comparator group

Description:

Patients took oral standardized Ginkgo biloba extracts (120 mg daily) three times a day.

Treatment:

Drug: Ginkgo Biloba Extract