Investigating the Efficacy of Short-term Oral Prednisone Therapy on Acute Subjective Tinnitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- tinnitus handicap inventory (THI)
研究概览
简要总结
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.
详细描述
Researchers will compare the intervention group and placebo-control group to see whether short-term systemic steroid therapy is effective 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-65 years old;
- •a primary complaint of frequent occurrences of subjective tinnitus lasting at least 5 minutes within the past 3 months ;
- •a definition of normal hearing in line with the World Report on Hearing (2021), of which the average value of hearing threshold at 500, 1000, 2000, 4000 Hz in better ear was less than 20 decibels;
- •a score of more than 16 points on the Tinnitus Handicap Inventory (THI), which indicates that the level of tinnitus exceeds mild severity;
- •a state of good general condition.
排除标准
- •had previous history of middle ear pathology, apparent history of noise exposure, noise trauma or head injury;
- •had received treatment for their current condition before the study;
- •taken oral steroids within 3 months before randomization;
- •had hearing implants;
- •had participated in other clinical trials and have not terminated the trials;
- •had a history of known corticosteroid contraindications (including osteoporosis, peptic ulcers, poorly controlled hypertension, diabetes, chronic liver or renal insufficiency, tumorous condition, alcohol abuse, pregnancy, or taking estrogen-containing oral contraceptive steroids);
- •auditory hallucinations or other conditions deemed inappropriate for inclusion by the investigator.
研究组 & 干预措施
STOP group
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)
干预措施: Prednisone tablet (Drug)
STOP group
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)
干预措施: Ginkgo Biloba Extract (Drug)
placebol group
Patients took oral standardized Ginkgo biloba extracts (120 mg daily) three times a day.
干预措施: Ginkgo Biloba Extract (Drug)
结局指标
主要结局
tinnitus handicap inventory (THI)
时间窗: twelve 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.
次要结局
- visual analog scale (VAS)(twelve weeks from baseline)
- the Athens Insomnia Scale-8 (AIS-8)(twelve weeks from baseline)