Clinical Study of Wuling Capsule in the Treatment of Chronic Tinnitus With Emotional Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- the change of severity of tinnitus
研究概览
简要总结
To evaluate the effect of psychological/mental factors on the severity of subjective tinnitus, to observe the efficacy and safety of Wuling capsule in the treatment of chronic subjective tinnitus with emotional disorders, and to evaluate the control rate of tinnitus complications, such as depression, anxiety and insomnia, and the improvement of patients'quality of life.
详细描述
To evaluate the effect of psychological/mental factors on the severity of subjective tinnitus, to observe the efficacy and safety of Wuling capsule in the treatment of chronic subjective tinnitus with emotional disorders, and to evaluate the control rate of tinnitus complications, such as depression, anxiety and insomnia, and the improvement of patients'quality of life. Patients with chronic tinnitus complicated with mild to moderate anxiety or depression were randomly divided into two groups. The experimental group was given oral treatment with Wuling capsule, and the control group was given gurusu treatment. The improvement of tinnitus, sleep, anxiety and depression in patients was evaluated at 2,4 and 8 weeks after treatment, respectively, and the efficacy of Wuling capsule in improving tinnitus combined with anxiety, depression and tinnitus was analyzed。
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
- None
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
- •Tinnitus with a history longer than 6 months;
- •7 < HAMD score < 24 and / or 7 < HAMA score < 21;
- •No antianxiety, depression or antipsychotic treatment within 2 weeks.
排除标准
- •objective tinnitus;
- •tinnitus with defined causes;
- •accompanied with acute infection, acute trauma, perioperative, chronic disease in the acute stage;
- •with mental illness family history;
- •HAMD score greater than 24 points or HAMA score greater than 21 points;
研究组 & 干预措施
Wuling Capsule group
Patients who were treated with Wuling Caspule
干预措施: Wuling Capsule (Drug)
Oryzanol group
Patients who were treated with oryzanol
干预措施: Oryzanol (Drug)
结局指标
主要结局
the change of severity of tinnitus
时间窗: 8 weeks
tinnitus handicap index is to evaluate the severity of tinnitus
次要结局
- the change of anxiety level(8 weeks)
- the change of depression level(8 weeks)