Small Sample，Unicentric，Randomized, Controlled Clinical Study of Coenzyme I for Injection in the Treatment of Sudden Sensorineural Hearing Loss
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Pure Tone Average(PTA)
研究概览
简要总结
Sudden sensorineural hearing loss is one of the most common emergencies in otorhinolaryngology, and its incidence is increasing year by year and tends to be younger. At present, the pathogenesis of sudden deafness is not clear and the individual treatment effects vary significantly. In order to break through this specific treatment bottleneck, this project pioneered the clinical application of the co-regulator nicotinamide adenine dinucleotide (NAD+) in the treatment of sudden deafness. Therefore, this project intends to use pure tone audiometry, speech audiometry, tinnitus disability scale THI, tinnitus subjective visual analog score method VAS, ear fullness subjective visual analog score method VAS for data analysis, and explore the safety of coenzyme I for injection on sudden deafness and efficacy assessment.
详细描述
The recruited participants were patients with sudden hearing deafness, and the basic demographic data, including name, gender, age, medical history, etc., were collected. According to the inclusion and exclusion criteria, the patients were randomly divided into the experimental group and the control group. The experimental group was given conventional treatment + coenzyme I for injection, and the control group was given conventional treatment for 14 days. Baseline data were collected before treatment, and post-treatment data were collected on 3d, 7d, 14d，1m and 3m of treatment. Baseline data and post-treatment data included pure tone audiometry, speech audiometry, tinnitus THI scale, tinnitus VAS scale, tinnitus Stupid VAS scale.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18yrs.the 2019 American Sudden Deafness Guidelines are for patients with sudden deafness over 18 years of age;
- •Patients diagnosed with sudden deafness, i.e. unexplained sensorineural hearing loss occurring within 72 hours, with hearing threshold ≥30 in at least 3 consecutive frequencies, refer to the 2019 American Sudden Deafness Guidelines;
- •Unilateral sudden deafness;
- •Within 1 week of the onset of sudden deafness, no treatment in another hospital/our hospital;
- •No major neurological disease, serious systemic disease, family genetic history, major mental illness;
- •Informed and agreed to join the experiment, no plan to move out or go out within 1 month.
排除标准
- •Other diseases such as acoustic neuroma diagnosed by imaging;
- •Those who cannot tolerate NAD+;
- •Any other circumstances that the investigator believes should be excluded from this study；
- •Do not agree to join the experiment, plan to move out or go out within 1 month.
研究组 & 干预措施
Intervention Group
Procedure:Coenzyme I for Injection,5mg，im，qd；Nacl，2ml，im，qd.
干预措施: Coenzyme I for Injection + conventional treatment (Drug)
Control Group
Procedure: conventional treatment.
干预措施: Conventional treatment (Drug)
结局指标
主要结局
Pure Tone Average(PTA)
时间窗: Treatment day 90
Pure tone audiometry is the most basic and preferred hearing test method, which can qualitatively and quantitatively diagnose hearing loss, can reflect the entire auditory conduction pathway from the external ear to the auditory center, and is currently one of the subjective behavioral hearing tests that can accurately reflect hearing acuity. Includes pure tone air conduction hearing threshold test and pure tone bone hearing threshold test.
次要结局
- Tinnitus Handicap Inventory(Treatment day 90)
- Visual Analogue Scale of Tinnitus(Treatment day 90)
- Severity of ear fullness(Treatment day 90)
- Speech Recognition Rate(Treatment day 90)