Comparing Two Dosing Regimens of the Efficacy of Short-term Oral Prednisone Therapy on Acute Subjective Tinnitus
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 162
- 主要终点
- tinnitus handicap inventory (THI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
dose-tapering regimen
The dose selection of oral prednisone is the maximum daily dose for 4 days, followed by a taper every 2 days
干预措施: Prednisone tablet (Drug)
dose-tapering regimen
The dose selection of oral prednisone is the maximum daily dose for 4 days, followed by a taper every 2 days
干预措施: Ginkgo Biloba Extract (Drug)
no taper regimen
The dose selection of oral prednisone is the maximum daily dose, applied for 5 consecutive days
干预措施: Prednisone tablet (Drug)
no taper regimen
The dose selection of oral prednisone is the maximum daily dose, applied for 5 consecutive days
干预措施: Ginkgo Biloba Extract (Drug)
结局指标
主要结局
tinnitus handicap inventory (THI)
时间窗: 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
次要结局
- visual analog scale (VAS)(one month from baseline)
- the Athens Insomnia Scale-8 (AIS-8)(one month from baseline)