Different Dosing Regimens of STOP-AST
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: dose-tapering regimen The dose selection of oral prednisone is the maximum daily dose for 4 days, followed by a taper every 2 days |
Drug: Prednisone tablet
Prednisone acetate tablet (5 mg prednisone acetate per tablet) was provided
Other Names:
Drug: Ginkgo Biloba Extract
Ginkgo biloba extract (EGb) is a compound drug derived from Ginkgo biloba trees native to China.
Other Names:
|
| Experimental: no taper regimen The dose selection of oral prednisone is the maximum daily dose, applied for 5 consecutive days |
Drug: Prednisone tablet
Prednisone acetate tablet (5 mg prednisone acetate per tablet) was provided
Other Names:
Drug: Ginkgo Biloba Extract
Ginkgo biloba extract (EGb) is a compound drug derived from Ginkgo biloba trees native to China.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- tinnitus handicap inventory (THI) [one week from baseline]
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
- tinnitus handicap inventory (THI) [two weeks from baseline]
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
- tinnitus handicap inventory (THI) [one month from baseline]
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
Secondary Outcome Measures
- visual analog scale (VAS) [one week from baseline]
mark the severity of tinnitus on a horizontal scale from 0 to 10. The higher the score, the more severe the symptoms.
- visual analog scale (VAS) [two weeks from baseline]
mark the severity of tinnitus on a horizontal scale from 0 to 10. The higher the score, the more severe the symptoms.
- visual analog scale (VAS) [one month from baseline]
mark the severity of tinnitus on a horizontal scale from 0 to 10. The higher the score, the more severe the symptoms.
- the Athens Insomnia Scale-8 (AIS-8) [one week from baseline]
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).
- the Athens Insomnia Scale-8 (AIS-8) [two weeks from baseline]
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).
- the Athens Insomnia Scale-8 (AIS-8) [one month from baseline]
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).
Eligibility Criteria
Criteria
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:
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a reduced distortion product otoacoustic emissions (DPOAE) amplitude in individuals with normal Pure tone audiometry (PTA) results;
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more than a PTA threshold > 20 dB with frequencies between 125 and 8000 Hz, but not exhibited idiopathic sudden sensorineural hearing loss;
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a state of good general condition;
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with good adherence to participation and signed informed consent.
Exclusion Criteria:
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active middle ear pathology;
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patients who had received treatment for their current condition prior to the study;
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both the PTA and DPOAE with normal outcomes;
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hearing implants;
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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).
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Eye & ENT Hospital of Fudan University
Investigators
- Principal Investigator: Shan Sun, Eye and ENT Hospital of Fudan University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- different STOP-AST regimens