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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dose-tapering regimen | Active Comparator | The dose selection of oral prednisone is the maximum daily dose for 4 days, followed by a taper every 2 days |
|
| no taper regimen | Experimental | The dose selection of oral prednisone is the maximum daily dose, applied for 5 consecutive days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisone tablet | Drug | Prednisone acetate tablet (5 mg prednisone acetate per tablet) was provided |
|
| 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 |
| 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) |
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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 state of good general condition;
with good adherence to participation and signed informed consent.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shan Sun | Contact | +86-18917786102 | sunshine7896@126.com | |
| Peifan Li | Contact | +86-18373151369 | 20211260020@fudan.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Shan Sun | Eye and ENT Hospital of Fudan University | Principal Investigator |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D014012 | Tinnitus |
| D006319 | Hearing Loss, Sensorineural |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| ID | Term |
|---|---|
| D011241 | Prednisone |
| C063170 | Ginkgo biloba extract |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Ginkgo Biloba Extract | Drug | Ginkgo biloba extract (EGb) is a compound drug derived from Ginkgo biloba trees native to China. |
|
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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 |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |