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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.
Researchers will compare the intervention group and placebo-control group to see whether short-term systemic steroid therapy is effective for acute tinnitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STOP group | Experimental | 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) |
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| placebol group | Placebo Comparator | Patients took oral standardized Ginkgo biloba extracts (120 mg daily) three times a day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisone tablet | Drug | The dose selection of oral prednisone is the maximum daily dose based on weight for 4 days, followed by a taper every 2 days, with the maximum duration to 14 days. |
| 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. | 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. | four 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. | twelve weeks from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| visual analog scale (VAS) | The subjective perception of tinnitus loudness will be evaluated using a Visual Analog Scale (VAS). Participants will be instructed to rate the perceived loudness of their tinnitus on a scale ranging from 0, indicating "no loudness," to 10, representing "maximum imaginable loudness." Higher scores on this scale will correspond to greater perceived loudness of tinnitus symptoms. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shan Sun | Eye and ENT Hospital of Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye and ENT Hospital of Fudan University | Shanghai | China |
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| ID | Term |
|---|---|
| D014012 | Tinnitus |
| 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 |
| D000096983 | Ginkgo Extract |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Ginkgo Biloba Extract | Drug | Ginkgo biloba extracts are traditional Chinese medicine, which can improve microcirculation and provide good ameliorating effects for the treatment of tinnitus |
|
|
| two weeks from baseline |
| visual analog scale (VAS) | The subjective perception of tinnitus loudness will be evaluated using a Visual Analog Scale (VAS). Participants will be instructed to rate the perceived loudness of their tinnitus on a scale ranging from 0, indicating "no loudness," to 10, representing "maximum imaginable loudness." Higher scores on this scale will correspond to greater perceived loudness of tinnitus symptoms. | four weeks from baseline |
| visual analog scale (VAS) | The subjective perception of tinnitus loudness will be evaluated using a Visual Analog Scale (VAS). Participants will be instructed to rate the perceived loudness of their tinnitus on a scale ranging from 0, indicating "no loudness," to 10, representing "maximum imaginable loudness." Higher scores on this scale will correspond to greater perceived loudness of tinnitus symptoms. | twelve 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). | 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). | four 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). | twelve weeks 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 |
| D010936 | Plant Extracts |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |