Tinnitus, Subjective
Conditions
Brief summary
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.
Detailed description
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。
Interventions
DRUGWuling Capsule
take Wuling Capsule in experiment group for 2 months
DRUGOryzanol
take oryzanol in active comparator group for 2 months
Sponsors
Xijing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the change of severity of tinnitus | 8 weeks | tinnitus handicap index is to evaluate the severity of tinnitus |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the change of anxiety level | 8 weeks | Hamilton anxiety scale is to evaluate the anxiety level |
| the change of depression level | 8 weeks | Hamilton depression scale is to evaluate the depression level |
Countries
China
Outcome results
None listed