Different Dosing Regimens of STOP-AST

Study Overview
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Brief Summary
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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.

Detailed Description
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The purpose of this clinical study was to investigate the efficacy and to compare two different oral doses of short-term systemic steroid therapy for acute tinnitus.

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

Conditions
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Hearing Loss, Tinnitus, Sensorineural Hearing Loss

Intervention / Treatment
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* Drug: Prednisone tablet
* Drug: Ginkgo Biloba Extract


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-60 years old; primary complaint of subjective tinnitus ≤ 1 months of duration; 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: a reduced distortion product otoacoustic emissions (DPOAE) amplitude in individuals with normal Pure tone audiometry (PTA) results; more than a PTA threshold > 20 dB with frequencies between 125 and 8000 Hz, but not exhibited idiopathic sudden sensorineural hearing loss; a state of good general condition; with good adherence to participation and signed informed consent. Exclusion Criteria: active middle ear pathology; patients who had received treatment for their current condition prior to the study; both the PTA and DPOAE with normal outcomes; hearing implants; 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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: dose-tapering regimen<br>The dose selection of oral prednisone is the maximum daily dose for 4 days, followed by a taper every 2 days | Drug: Prednisone tablet<br>* Prednisone acetate tablet (5 mg prednisone acetate per tablet) was provided<br>* Other names: Prednisone;Drug: Ginkgo Biloba Extract<br>* Ginkgo biloba extract (EGb) is a compound drug derived from Ginkgo biloba trees native to China.<br>* Other names: EGb;|
| Experimental: no taper regimen<br>The dose selection of oral prednisone is the maximum daily dose, applied for 5 consecutive days | Drug: Prednisone tablet<br>* Prednisone acetate tablet (5 mg prednisone acetate per tablet) was provided<br>* Other names: Prednisone;Drug: Ginkgo Biloba Extract<br>* Ginkgo biloba extract (EGb) is a compound drug derived from Ginkgo biloba trees native to China.<br>* Other names: EGb;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tinnitus handicap inventory (THI) | The THI is a self-administered test, including 25 questions with grades four categories of tinnitus severity: slight corresponding to a score of 0-16, mild (18-36), moderate (38-56), severe (58-100). The higher the score the more severe the tinnitus | one week from baseline | 
| tinnitus handicap inventory (THI) | The THI is a self-administered test, including 25 questions with grades four categories of tinnitus severity: slight corresponding to a score of 0-16, mild (18-36), moderate (38-56), severe (58-100). The higher the score the more severe the tinnitus | two weeks from baseline | 
| tinnitus handicap inventory (THI) | The THI is a self-administered test, including 25 questions with grades four categories of tinnitus severity: slight corresponding to a score of 0-16, mild (18-36), moderate (38-56), severe (58-100). The higher the score the more severe the tinnitus | one month from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analog scale (VAS) | mark the severity of tinnitus on a horizontal scale from 0 to 10. The higher the score, the more severe the symptoms. | one week from baseline | 
| visual analog scale (VAS) | mark the severity of tinnitus on a horizontal scale from 0 to 10. The higher the score, the more severe the symptoms. | two weeks from baseline | 
| visual analog scale (VAS) | mark the severity of tinnitus on a horizontal scale from 0 to 10. The higher the score, the more severe the symptoms. | one month from baseline | 
| the Athens Insomnia Scale-8 (AIS-8) | The AIS comprises eight items that commonly measure difficulties in falling asleep or maintaining sleep to quantify the presence of insomnia. The higher the AIS score, the lower the sleep quality and mental status. The AIS identifies three types of sleep disorders: no insomnia (score below 4), suspicious (4-6), and insomnia (score between 7-24). | one week from baseline | 
| the Athens Insomnia Scale-8 (AIS-8) | The AIS comprises eight items that commonly measure difficulties in falling asleep or maintaining sleep to quantify the presence of insomnia. The higher the AIS score, the lower the sleep quality and mental status. The AIS identifies three types of sleep disorders: no insomnia (score below 4), suspicious (4-6), and insomnia (score between 7-24). | two weeks from baseline | 
| the Athens Insomnia Scale-8 (AIS-8) | The AIS comprises eight items that commonly measure difficulties in falling asleep or maintaining sleep to quantify the presence of insomnia. The higher the AIS score, the lower the sleep quality and mental status. The AIS identifies three types of sleep disorders: no insomnia (score below 4), suspicious (4-6), and insomnia (score between 7-24). | one month from baseline |