Comparing Two Dosing Regimens of the Efficacy of Short-term Oral Prednisone Therapy on Acute Subjective Tinnitus

different STOP-AST regimens

The goal of this clinical trial is to learn about the different dose regimens of the efficacy of oral steroids in the acute tinnitus population. Participants will receive different appropriate dosages of prednisone tablets and oral Ginkgo Biloba tablets.

2023-11-10

2024-02-10

2024-11-30

Not yet recruiting

162

Inclusion Criteria: 1. 18-60 years old; 2. primary complaint of subjective tinnitus ≤ 1 months of duration; 3. a decline in auditory function by audiological assessments on the day of the test, of which the outcome must either satisfy one of the following conditions: 1. a reduced distortion product otoacoustic emissions (DPOAE) amplitude in individuals with normal Pure tone audiometry (PTA) results; 2. more than a PTA threshold \> 20 dB with frequencies between 125 and 8000 Hz, but not exhibited idiopathic sudden sensorineural hearing loss; 4. a state of good general condition; 5. with good adherence to participation and signed informed consent. Exclusion Criteria: 1. active middle ear pathology; 2. patients who had received treatment for their current condition prior to the study; 3. both the PTA and DPOAE with normal outcomes; 4. hearing implants; 5. history of known corticosteroids contraindications (including osteoporosis, peptic ulcers, poorly controlled hypertension, diabetes, chronic liver or renal insufficiency, tumorous condition, alcohol abuse, pregnant patients, and women on estrogen-containing oral contraceptive steroids).

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 162, 'type': 'ESTIMATED'}}

2023-11-13